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Trial record 3 of 12 for:    18779236 [PUBMED-IDS]

Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00406133
Recruitment Status : Completed
First Posted : December 4, 2006
Results First Posted : September 2, 2009
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
JDRF Artificial Pancreas Project
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Device: Continuous glucose monitor
Enrollment 451
Recruitment Details Participants were recruited from within the patient population of the study clinical centers.
Pre-assignment Details Participants completed a run-in phase wearing a blinded continuous glucose monitoring (CGM) device. Eligibility required that a sensor be worn for six out of seven days prior to randomization, with a minimum of 96 hours of glucose values with at least 24 hours overnight, and home blood glucose monitoring be performed at least three times daily.
Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
Hide Arm/Group Description Participants with baseline A1c >=7.0% who were randomized to CGM use Participants with baseline A1c >=7.0% who were randomized to standard care Participants with baseline A1c <7.0% who were randomized to CGM use Participants with baseline A1c <7.0% who were randomized to standard care
Period Title: Phase 1 (First 26 Week Period)
Started 165 157 67 62
Completed 162 155 67 60
Not Completed 3 2 0 2
Period Title: Phase 2 (Second 26 Week Period)
Started 159 [1] 155 67 60
Completed 157 152 67 60
Not Completed 2 3 0 0
[1]
3 subjects completed phase 1 but elected not to go into phase 2.
Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group Total
Hide Arm/Group Description Participants with baseline A1c >=7.0% who were randomized to CGM use Participants with baseline A1c >=7.0% who were randomized to standard care Participants with baseline A1c <7.0% who were randomized to CGM use Participants with baseline A1c <7.0% who were randomized to standard care Total of all reporting groups
Overall Number of Baseline Participants 165 157 67 62 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
8-14 years 56 58 18 11 143
15-24 years 57 53 15 18 143
>=25 years 52 46 34 33 165
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
Female
87
  52.7%
93
  59.2%
36
  53.7%
32
  51.6%
248
  55.0%
Male
78
  47.3%
64
  40.8%
31
  46.3%
30
  48.4%
203
  45.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
Non-Hispanic White 150 146 63 58 417
Other 15 11 4 4 34
College graduate (subject or primary care giver)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
College graduate 125 125 58 55 363
Other 40 32 9 7 88
Insulin modality  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
Pump 128 128 62 49 367
Multiple daily injections 37 29 5 13 84
One or more severe hypoglycemic events in last six months  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
One or more events 14 10 7 7 38
No events 151 147 60 55 413
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
8-14 years 6.2  (3.1) 5.3  (2.8) 4.9  (2.6) 4.4  (3.2) 5.5  (3.0)
15-24 years 9.5  (4.8) 8.8  (4.0) 8.7  (5.3) 8.1  (4.5) 9.0  (4.5)
>=25 years 23.6  (10.6) 21.8  (10.4) 25.6  (16.6) 28.6  (12.7) 24.5  (12.6)
Glycated hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 165 participants 157 participants 67 participants 62 participants 451 participants
7.9  (0.7) 7.8  (0.7) 6.4  (0.5) 6.5  (0.3) 7.4  (0.9)
1.Primary Outcome
Title Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort)
Hide Description The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c >=7.0% cohort).
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Mean (Standard Deviation)
Unit of Measure: Percent
8-14 years -0.37  (0.90) -0.22  (0.54)
15-24 years -0.18  (0.65) -0.21  (0.61)
>=25 years -0.50  (0.56) 0.02  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments

A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.

P value is for age 8-14 group.

Method ANCOVA
Comments Performed in each age group and adjusted for the baseline A1c and clinical center.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments

A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.

P value for age 15-24 group.

Method ANCOVA
Comments Performed in each age group and adjusted for the baseline A1c and clinical center.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments

A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.

P value is for age >=25 group.

Method ANCOVA
Comments Performed in each age group and adjusted for the baseline A1c and clinical center.
2.Primary Outcome
Title Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%)
Hide Description The primary outcome was the change in the time per day with glucose values <=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 66 60
Median (Inter-Quartile Range)
Unit of Measure: minutes/day
54
(28 to 108)
91
(27 to 188)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments P-value was for the comparison of RT-CGM group and Control group.
Method ANCOVA
Comments Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
3.Secondary Outcome
Title Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort)
Hide Description Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c >=7.0% cohort
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: subjects with event
8-14 years (>=1 Severe hypoglycemic event) 4 6
15-24 years (>=1 Severe hypoglycemic event) 3 5
>=25 years (>=1 Severe hypoglycemic event) 5 4
8-14 years (>=1 Severe hypo with seizure or coma) 0 0
15-24 years (>=1 Severe hypo with seizure or coma) 1 3
>=25 years (>=1 Severe hypo with seizure or coma) 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments P-value is for N(%) of subjects with >=1 severe hypo event in the 8-14 year age group.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments P-value is for N(%) of subjects with >=1 severe hypo event in the 15-24 year age group.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value is for N(%) of subjects with >=1 severe hypo event in the >=25 year age group.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the 8-14 year age group.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the 15-24 year age group.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the >=25 year age group.
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
Hide Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Mean (Standard Deviation)
Unit of Measure: minutes/day
8-14 years (Baseline) 646  (179) 710  (187)
8-14 years (26 Weeks) 750  (215) 746  (223)
15-24 years (Baseline) 691  (208) 697  (201)
15-24 years (26 Weeks) 761  (188) 761  (200)
>=25 years (Baseline) 854  (202) 811  (226)
>=25 years (26 Weeks) 986  (189) 840  (165)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort)
Hide Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Mean (Standard Deviation)
Unit of Measure: minutes/day
8-14 years (Baseline) 745  (200) 671  (206)
8-14 years (26 Weeks) 643  (231) 635  (240)
15-24 years (Baseline) 650  (227) 641  (198)
15-24 years (26 Weeks) 591  (226) 591  (203)
>=25 years (Baseline) 497  (216) 549  (248)
>=25 years (26 Weeks) 394  (200) 519  (185)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
6.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort
Hide Description Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Mean (Standard Deviation)
Unit of Measure: minutes/day
8-14 years (Baseline) 343  (177) 282  (151)
8-14 years (26 Weeks) 242  (167) 268  (172)
15-24 years (Baseline) 271  (162) 265  (157)
15-24 years (26 Weeks) 215  (154) 242  (187)
>=25 years (Baseline) 149  (112) 181  (150)
>=25 years (26 Weeks) 101  (116) 161  (103)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
7.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
Hide Description Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Mean (Standard Deviation)
Unit of Measure: minutes/day
8-14 years (Baseline) 49  (68) 59  (67)
8-14 years (26 Weeks) 47  (59) 59  (60)
15-24 years (Baseline) 99  (79) 102  (93)
15-24 years (26 Weeks) 88  (88) 88  (79)
>=25 years (Baseline) 89  (128) 80  (71)
>=25 years (26 Weeks) 60  (54) 81  (89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort RT-CGM Group, Primary Cohort Control Group
Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort RT-CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort RT-CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
8.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%)
Hide Description Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Mean (Standard Deviation)
Unit of Measure: minutes/day
8-14 years (Baseline) 17  (39) 18  (34)
8-14 years (26 Weeks) 10  (21) 13  (22)
15-24 years (Baseline) 37  (49) 42  (61)
15-24 years (26 Weeks) 29  (48) 31  (43)
>=25 years (Baseline) 32  (86) 22  (30)
>= 25 years (26 Weeks) 11  (19) 23  (37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
9.Secondary Outcome
Title Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%)
Hide Description Glucose variability was assessed by computing the absolute rate of change.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Mean (Standard Deviation)
Unit of Measure: Mean mg/dl/minute
8-14 years (Baseline) 0.84  (0.18) 0.83  (0.17)
8-14 years (26 Weeks) 0.82  (0.21) 0.83  (0.21)
15-24 years (Baseline) 0.85  (0.25) 0.86  (0.17)
15-24 years (26 Weeks) 0.84  (0.21) 0.87  (0.21)
>=25 years (Baseline) 0.73  (0.18) 0.72  (0.18)
>=25 years (26 Weeks) 0.68  (0.15) 0.74  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Glucose variability was assessed by computing the absolute rate of change.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.
Method ANCOVA
Comments Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.
10.Secondary Outcome
Title Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort)
Hide Description The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c <7.0% cohort), as determined by a central laboratory.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed according to Intention to Treat principle. Results based on non-missing data were reported. Imputation for missing data using Rubin's method did not alter the results (data not shown).
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 67 62
Mean (Standard Deviation)
Unit of Measure: Percent
0.02  (0.45) 0.33  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for baseline A1c and clinical center.
11.Secondary Outcome
Title Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
Hide Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 66 60
Median (Inter-Quartile Range)
Unit of Measure: minutes/day
1063
(948 to 1185)
949
(784 to 1106)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
Method ANCOVA
Comments Adjusted for baseline value, clinical center and type of continuous glucose monitor.
12.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%)
Hide Description Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 66 60
Median (Inter-Quartile Range)
Unit of Measure: minutes/day
283
(173 to 423)
341
(232 to 502)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments P-value representative of 13 and 26 weeks combined.
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort
Hide Description Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 66 60
Median (Inter-Quartile Range)
Unit of Measure: minutes/day
48
(11 to 103)
82
(22 to 149)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value representative of 13 and 26 weeks combined
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%)
Hide Description Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (<=50 mg/dL)
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 66 60
Median (Inter-Quartile Range)
Unit of Measure: minutes/day
4
(0 to 15)
8
(0 to 55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments P-value representative of 13 and 26 weeks combined.
Method ANCOVA
Comments [Not Specified]
15.Secondary Outcome
Title Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%)
Hide Description Glucose variability was assessed by computing the absolute rate of change.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 66 60
Median (Inter-Quartile Range)
Unit of Measure: mg/dl/min
0.66
(0.53 to 0.76)
0.66
(0.54 to 0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Glucose variability was assessed by computing the absolute rate of change.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments P-value representative of 13 and 26 weeks combined.
Method ANCOVA
Comments [Not Specified]
16.Secondary Outcome
Title Quality of Life
Hide Description Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants >= 18 years of age. Pools participants with baseline HbA1c <7.0% and >=7.0%.
Arm/Group Title CGM Group Control Group
Hide Arm/Group Description:
Participants who were randomized to CGM use
Participants randomized to SMBG
Overall Number of Participants Analyzed 120 106
Mean (Standard Deviation)
Unit of Measure: units on a scale
33.3  (11.5) 36.0  (13.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CGM Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments Nominal p-value not adjusted for multiple comparisons
Method ANCOVA
Comments [Not Specified]
17.Secondary Outcome
Title Cost-effectiveness of CGM.
Hide Description Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline A1c<7%.
Arm/Group Title CGM Group Control Group
Hide Arm/Group Description:
Participants randomized to CGM Use
Participants randomized to SMBG
Overall Number of Participants Analyzed 67 62
Measure Type: Number
Unit of Measure: dollars per QALY
70904 49438
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CGM Group, Control Group
Comments

ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups:

(mean cost[CGM] - mean cost [control]) / (mean QALY[CGM] - mean QALY[SMBG]).

Units are dollars per QALY.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of treatment differences
Estimated Value 408148
Confidence Interval (2-Sided) 95%
-176644 to 3475108
Estimation Comments [Not Specified]
18.Secondary Outcome
Title QALW
Hide Description Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged <18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline A1c <7.0%
Arm/Group Title CGM Group Control Group
Hide Arm/Group Description:
Participants who were randomized to CGM use
Participants randomized to SMBG
Overall Number of Participants Analyzed 67 62
Mean (Standard Error)
Unit of Measure: weeks
23.23  (0.81) 21.84  (0.66)
19.Secondary Outcome
Title Total Costs: Direct and Indirect Costs
Hide Description Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09–2042/DC1 (Table 1).
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline A1c < 7.0%
Arm/Group Title CGM Group Control Group
Hide Arm/Group Description:
Participants who were randomized to CGM use
Participants randomized to SMBG
Overall Number of Participants Analyzed 67 62
Mean (Standard Error)
Unit of Measure: dollars
31675  (6292) 20764  (4351)
20.Other Pre-specified Outcome
Title Relative Decrease in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
Hide Description A relative decrease in A1c level >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: participants
8-14 years 16 7
15-24 years 8 5
>=25 years 13 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments P-value for the 8-14 year old age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments P-value for the 15-24 year age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-value for the >=25 year age group
Method Regression, Logistic
Comments [Not Specified]
21.Other Pre-specified Outcome
Title Relative Increase in A1c Level by >=10% (for Cohort With Baseline HbA1c >=7.0%)
Hide Description A relative increase in A1c level by >=10% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: participants
8-14 years 5 2
15-24 years 2 2
>=25 years 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments P-value for 8-14 year old age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments P-value for the 15-24 year old age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments P-value for the >=25 year old age group
Method Regression, Logistic
Comments [Not Specified]
22.Other Pre-specified Outcome
Title Relative Decrease in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
Hide Description A relative decrease A1c level by >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: participants
8-14 years 30 18
15-24 years 20 19
>=25 years 24 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments P-value for the 8-14 year old age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments P-value for 15-24 year old age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for the >=25 year old age group
Method Regression, Logistic
Comments [Not Specified]
23.Other Pre-specified Outcome
Title Relative Increase in A1c Level by >=0.5% (for Cohort With Baseline HbA1c >=7.0%)
Hide Description A relative increase by in A1c level >=0.5% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HBA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: participants
8-14 years 12 7
15-24 years 7 7
>=25 years 0 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments P-value for 8-14 year age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments P-value for 15-24 year old age group.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments P-value for >=25 year old age group.
Method Regression, Logistic
Comments [Not Specified]
24.Other Pre-specified Outcome
Title 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c >=7.0%)
Hide Description A 26-week A1c level <7.0% was evaluated in logistic-regression models, adjusted for the baseline glycated hemoglobin level and clinical center.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: participants
8-14 years 15 7
15-24 years 8 9
>= 25 years 17 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments P-value for 8-14 year age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments P-value for 14-24 year age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments P-value for >=25 year age group
Method Regression, Logistic
Comments [Not Specified]
25.Other Pre-specified Outcome
Title Decrease in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
Hide Description Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 67 62
Measure Type: Number
Unit of Measure: participants
21 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
26.Other Pre-specified Outcome
Title Increase in A1c From Baseline by >=0.3% (for Cohort With Baseline HbA1c <7.0%)
Hide Description Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 67 62
Measure Type: Number
Unit of Measure: participants
19 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
27.Other Pre-specified Outcome
Title 26-week A1c Level <7.0% (for Cohort With Baseline HbA1c <7.0%)
Hide Description Other preplanned secondary outcomes included change in HbA1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline HbA1c and clinical center) and 26-week binary HbA1c outcomes evaluated similarly in logistic regression models.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c <7.0% who were randomized to CGM use
Participants with baseline HbA1c <7.0% who were randomized to standard care
Overall Number of Participants Analyzed 67 62
Measure Type: Number
Unit of Measure: participants
59 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
28.Post-Hoc Outcome
Title 26-week A1c Level <7.0%, With no Severe Hypoglycemic Events for Cohort With Baseline HbA1c >=7.0%)
Hide Description A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were performed according to the intention-to-treat principle.
Arm/Group Title Primary Cohort CGM Group Primary Cohort Control Group
Hide Arm/Group Description:
Participants with baseline HbA1c >=7.0% who were randomized to CGM use
Participants with baseline HbA1c >=7.0% who were randomized to standard care
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: participants
8-14 years 14 6
15-24 years 7 7
>=25 years 15 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments P-value for the 8-14 year age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments P-value for the 15-24 year old age group
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Primary Cohort CGM Group, Primary Cohort Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value for the >=25 year old age group
Method Regression, Logistic
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
Hide Arm/Group Description Participants with baseline A1c >=7.0% who were randomized to CGM use Participants with baseline A1c >=7.0% who were randomized to standard care Participants with baseline A1c <7.0% who were randomized to CGM use Participants with baseline A1c <7.0% who were randomized to standard care
All-Cause Mortality
Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/165 (4.24%)      12/157 (7.64%)      7/67 (10.45%)      7/62 (11.29%)    
Endocrine disorders         
Severe Hypoglycemia * [1]  7/165 (4.24%)  7 12/157 (7.64%)  12 7/67 (10.45%)  7 7/62 (11.29%)  7
*
Indicates events were collected by non-systematic assessment
[1]
Defined as an event that required assistance from another person to administer oral carbohydrate, glucagon, or other resuscitative actions.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Primary Cohort RT-CGM Group Primary Cohort Control Group Secondary Cohort RT-CGM Group Secondary Cohort Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/165 (2.42%)      3/157 (1.91%)      0/67 (0.00%)      0/62 (0.00%)    
Endocrine disorders         
Diabetic ketoacidosis *  0/165 (0.00%)  0 1/157 (0.64%)  1 0/67 (0.00%)  0 0/62 (0.00%)  0
General disorders         
Seizure not caused by hypoglycemia *  1/165 (0.61%)  1 0/157 (0.00%)  0 0/67 (0.00%)  0 0/62 (0.00%)  0
Injury, poisoning and procedural complications         
Dizziness during blood draw *  0/165 (0.00%)  0 1/157 (0.64%)  1 0/67 (0.00%)  0 0/62 (0.00%)  0
Kidney laceration *  0/165 (0.00%)  0 1/157 (0.64%)  1 0/67 (0.00%)  0 0/62 (0.00%)  0
Psychiatric disorders         
Anxiety and depression *  1/165 (0.61%)  1 0/157 (0.00%)  0 0/67 (0.00%)  0 0/62 (0.00%)  0
Skin and subcutaneous tissue disorders         
Cellulitis related to sensor use *  2/165 (1.21%)  2 0/157 (0.00%)  0 0/67 (0.00%)  0 0/62 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Roy W. Beck, M.D., Ph.D., Director
Organization: Jaeb Center for Health Research
Phone: 813-975-8690
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00406133     History of Changes
Other Study ID Numbers: 2006-2402
First Submitted: November 30, 2006
First Posted: December 4, 2006
Results First Submitted: May 11, 2009
Results First Posted: September 2, 2009
Last Update Posted: April 14, 2017