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Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes (BPK002)

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ClinicalTrials.gov Identifier: NCT00315939
Recruitment Status : Completed
First Posted : April 19, 2006
Results First Posted : September 9, 2014
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boris Kovatchev, PhD, University of Virginia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Diabetes Mellitus, Type 1
Interventions Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)
Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
Enrollment 120
Recruitment Details A total of 120 adults with type 1 diabetes were recruited through regional advertising. Inclusion criteria were age ≥18 years, type 1 diabetes defined by the American Diabetes Association criteria or physician judgment, and willingness to participate in the study for up to 12 months performing finger sticks four to five times per day.
Pre-assignment Details  
Arm/Group Title Experimental: Group A Order: SMBG, IBMF-1, IBMF-2 Experimental: Group B Order: IBMF-1, IBMF-2, SMBG
Hide Arm/Group Description Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
Period Title: Admission 1 (3 Months)
Started 59 61
Completed 56 55
Not Completed 3 6
Period Title: Admission 2 (3 Months)
Started 56 55
Completed 52 51
Not Completed 4 4
Period Title: Admission 3 (3 Months)
Started 52 51
Completed 48 49
Not Completed 4 2
Arm/Group Title Experimental: Group A Order: SMBG, IBMF-1, IBMF-2 Experimental: Group B Order: IBMF-1, IBMF-2, SMBG Total
Hide Arm/Group Description Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months. Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months. Total of all reporting groups
Overall Number of Baseline Participants 59 61 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 61 participants 120 participants
40.65  (14.84) 37.61  (13.78) 39.15  (14.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 61 participants 120 participants
Female
33
  55.9%
36
  59.0%
69
  57.5%
Male
26
  44.1%
25
  41.0%
51
  42.5%
1.Primary Outcome
Title Hemoglobin A1c
Hide Description [Not Specified]
Time Frame 1 year (each level lasted 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using “dropout” as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.
Arm/Group Title Experimental Groups A and B
Hide Arm/Group Description:

Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.

Each level continued for 3 months.

IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.

IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.

Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: percentage of glycated hemoglobin
Baseline 7.99  (1.48)
Post-Level 1 7.69  (1.30)
Post-Level 2 7.69  (1.33)
Post-Level 3 7.58  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Groups A and B
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Frequency of Severe Hypoglycemia
Hide Description Severe hypoglycemia (SH) was defined to subjects as "blood glucose so low that you could not treat yourself because you were stuporous or unconscious."
Time Frame 1 year (each level lasted 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using "dropout" as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.
Arm/Group Title Experimental Groups A and B
Hide Arm/Group Description:

Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.

Each level continued for 3 months.

IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.

IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.

Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: episodes/month/person
SH Baseline 0.09
SH Post-Level 1 0.21
SH Post-Level 2 0.15
SH Post-Level 3 0.02
Time Frame January 2006 - December 2009
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IBMF-1 IBMF-2
Hide Arm/Group Description IBMF-1 will use the OneTouch® UltraSmart® glucometer (LifeScan, Milpitas, CA) to collect routine SMBG data and the subject transfers the blood glucose (BG) value into a hand-held computer (HHC) for processing. As the subject checks BG on a daily basis, the IBMF-1 software calculates an estimate of HbA1c, acute risk for hypoglycemia and chronic risk for hypoglycemia. This information will be presented back to the subject. Specifically, (i) alarms for immediate action if BG<50 mg/dL is registered; (ii) a running HbA1c estimate (71); (iii) a warning to be more careful and measure BG more frequently over the next 24 hours if elevated acute risk for hypoglycemia is found, and (iv) an indication of the subject's chronic risk for hypoglycemia in one of 4 categories (minimal, low, moderate, and high). At moderate and high risk the subject will be prompted to consider altering his/her behavior. HbA1c and chronic risk change slowly (2-3 weeks), while acute risk can change daily. IBMF-2 retains level 2, but the HHC asks subjects to provide symptom ratings when BG (blood glucose) is low and at an equal number of matching euglycemic readings. From these data, the HHC estimates a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
All-Cause Mortality
IBMF-1 IBMF-2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IBMF-1 IBMF-2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/117 (0.00%)   0/107 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IBMF-1 IBMF-2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/117 (0.00%)   0/107 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Boris Kovatchev, PhD
Organization: University of Virginia
Phone: 434-924-5592
Responsible Party: Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier: NCT00315939     History of Changes
Other Study ID Numbers: 12126
First Submitted: April 18, 2006
First Posted: April 19, 2006
Results First Submitted: August 8, 2014
Results First Posted: September 9, 2014
Last Update Posted: September 18, 2014