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Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)

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ClinicalTrials.gov Identifier: NCT01030341
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : September 3, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Gastroparesis
Intervention Device: CGMS and insulin pump
Enrollment 45

Recruitment Details Forty-five patients (age 18-70 years) with diabetes for >2 years in poor glycemic control (HbA1c >8%) with gastroparesis were recruited from 7 centers of the GpCRC from February 2012 through May 2014. Patients had symptoms for >1 year with Gastroparesis Cardinal Symptom Index (GCSI) scores of ≥18.
Pre-assignment Details

Screening Phase-Baseline glycemic profiles were obtained with blinded sensors to acquire >216 hours of glycemic data over 2 weeks.

Run-In Phase:Participants received detailed instructions in operating the CSII device and had to demonstrate competency in CSII and CGM and electronic CGM data transfer to be enrolled.

Arm/Group Title All Participants
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Continuous glucose monitoring in conjunction with insulin pump

CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump

Period Title: Overall Study
Started 45 [1]
Completed 42 [2]
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             2
[1]
45 participants met all enrollment criteria by completing the screening and run-in phases
[2]
42 participants completed the study
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Continuous glucose monitoring in conjunction with insulin pump

CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
45  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
31
  68.9%
Male
14
  31.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Hispanic or Latino
11
  24.4%
Not Hispanic or Latino
34
  75.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
Known diabetes duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
21  (11)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 45 participants
29  (8)
Hemoglobin A1c  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 45 participants
9.4  (1.4)
2 hr gastric retention  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 45 participants
63  (20)
4 hr gastric retention  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 45 participants
32  (20)
GCSI score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 45 participants
3.3  (0.8)
[1]
Measure Description: The Gastroparesis Cardinal Symptom Index (GCSI) is the mean of 3 subscales: nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), and bloating (2 items). Subscale scores were calculated by averaging across items within a subscale. A 6-point Likert scale was used for scoring individual items ranging from 0 (none) to 5 (very severe).
PAGI-QOL   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 45 participants
2.4  (1.1)
[1]
Measure Description: The Patient Assessment of Upper Gastrointestinal Disorders-Quality of LIfe (PAGI-QOL) contains 30 items with 5 subscales: (1) daily activities; (2) clothing; (3) diet/food habits; (4) relationship; and (5) psychological well-being and distress. Items are scored on a 6-point Likert scale, with response options ranging from 0 (none) to 5 (all of the time). Subscale scores are calculated by averaging the item responses within a each subscale after reversing item scores. A total score is calculated by averaging subscale scores, with higher values indicating improved quality of life.
Volume of Water consumed for water load satiety test   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 45 participants
430  (207)
[1]
Measure Description: The Water Load Satiety Test involves drinking cool water over 5 minutes until full. The outcome of interest is the volume of water drank in mL.
Volume consumed in a liquid nutrient satiety test   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 45 participants
420  (258)
[1]
Measure Description: The liquid nutrient satiety test involves drinking Ensure in 5 minutes until full. The outcome of interest is the amount drank in mL.
1.Primary Outcome
Title Hypoglycemic Episodes
Hide Description The incidence rate (events / person-week) of mild/moderate (glucose level < 70 mg/dL) and severe (glucose < 50 mg/dL) hypoglycemic episodes during screening vs 24 week of follow-up visits while using a combination of continuous glucose monitoring system (CGMS) and insulin pump therapy.
Time Frame 4 weeks screening vs 24 weeks follow-up
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Hide Analysis Population Description
44 patients had non-missing data during screening phase and 37 had non-missing data during treatment phase
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Continuous glucose monitoring in conjunction with insulin pump

CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump

Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: event rate per person-week
Screening phase, hypoglycemia / person-week 1.9
Treatment phase, hypoglycemia / person-week 2.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (<50 mg/dL) during the screening phase and treatment phase respectively.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Type I error: 0.05; power: 0.9
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance: p < 0.05
Method Regression, Logistic
Comments Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (<70 mg/dL) during the screening phase and treatment phase respectively.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Type I error: 0.05; power: 0.9
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance: p < 0.05
Method Regression, Logistic
Comments Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: Difference of 0% in the frequencies of euglycemic excursions (70-180 mg/dL) during the screening phase and treatment phase respectively.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Type I error: 0.05; power: 0.9
Statistical Test of Hypothesis P-Value 0.005
Comments Threshold for statistical significance: p < 0.05
Method Regression, Logistic
Comments Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (>180 mg/dL) during the screening phase and treatment phase respectively.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Type I error: 0.05; power: 0.9
Statistical Test of Hypothesis P-Value 0.04
Comments Threshold for statistical significance: p < 0.05
Method Regression, Logistic
Comments Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (>300 mg/dL) during the screening phase and treatment phase respectively.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Type I error: 0.05; power: 0.9
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for statistical significance: p < 0.05
Method Regression, Logistic
Comments Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases
2.Secondary Outcome
Title Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Hide Description

To determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis as assessed by GCSI total score and mean score and quality of life as assessed by PAGI-QOL score in diabetics with gastroparesis.

The outcome is assessed using the self-reported total GCSI score, which is computed as the average of the 3 subscores on the GCSI survey: 3-item postprandial fullness/early satiety subscore, the nausea/vomiting subscore (average of 3-items: nausea, retching, vomiting), and bloating subscore (average of 2-items: bloating, stomach visibly larger). Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the total score ranges from 0 to 5.

The self-reported PAGI-QOL total score which comprises 30 items scored from 0 (none of the time) to 5 (all of the time) the participant's QOL has been affected in the last 2 weeks.The total score is the mean of the 5 subscale scores and ranges from 0 (lowest QOL) to 5 (highest QOL) in past 2-weeks.

Time Frame Change from baseline (screening) vs 24 weeks of follow-up
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
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Continuous glucose monitoring in conjunction with insulin pump

CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump

Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change in total GCSI score, screening to 12 weeks -7.2  (8.2)
Change in total GCSI score, screening to 24 weeks -7.1  (9.1)
Change in GCSI composite, screening to 12 weeks -0.6  (0.9)
Change in GCSI composite, screening to 24 weeks -0.8  (1.0)
Change in PAGI-QOL score, screening to 12 weeks 0.7  (0.9)
Change in PAGI-QOL score, screening to 24 weeks 0.7  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: No difference in total GCSI score from screening to 12 weeks of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Mean change = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: No difference in total GCSI score from screening to 24 weeks of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Mean change = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Mean change = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Mean change = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Mean change = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Mean change = 0
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were categorized into 3 categories: (1) severe hypoglycemic events, (2) gastroparesis exacerbations which includes nausea, vomiting, abdominal pain and diarrhea and (3) other which includes cholecystectomy, bilateral otitis media, hyperglycemia, rash, dizziness, and retinal detachment.
 
Arm/Group Title All Participants
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Continuous glucose monitoring in conjunction with insulin pump

CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump

All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%) # Events
Total   16/45 (35.56%)    
Cardiac disorders   
Heart attack, screening/run-in phase  1/45 (2.22%)  1
Eye disorders   
Retinal detachment, screening/run-in phase  1/45 (2.22%)  1
Gastrointestinal disorders   
Severe gastroparesis exacerbation, screening/run-in phase  1/45 (2.22%)  2
Severe gastroparesis exacerbation, treatment phase  1/42 (2.38%)  1
Abdominal pain, nausea, vomiting, screening/run-in phase  1/45 (2.22%)  1
Abdominal pain, nausea, vomiting, treatment phase [1]  3/42 (7.14%)  3
General disorders   
Death of unknown cause, screening/run-in phase  1/45 (2.22%)  1
Metabolism and nutrition disorders   
Severe hypoglycemic events, screening/run-in phase  2/45 (4.44%)  2
Severe hypoglycemic events, treatment phase  6/42 (14.29%)  6
Severe hyperglycemic events, treatment phase  3/42 (7.14%)  3
Nervous system disorders   
Pain, numbness, paresthesia in hands, screening/run-in phase  1/45 (2.22%)  1
[1]
Also included anxiety in one case
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%) # Events
Total   12/45 (26.67%)    
Ear and labyrinth disorders   
Bilateral otitis externa, treatment phase [1]  1/42 (2.38%)  2
Gastrointestinal disorders   
Non-severe gastroparesis exacerbation, screening/run-in phase  2/45 (4.44%)  2
Non-severe gastroparesis exacerbation, treatment phase  2/42 (4.76%)  5
Abdominal pain, nausea, vomiting, screening/run-in phase [2]  2/45 (4.44%)  5
Abdominal pain, nausea, vomiting, treatment phase [3]  2/42 (4.76%)  2
Metabolism and nutrition disorders   
Non-severe hyperglycemia, screening/run-in phase  1/45 (2.22%)  1
Nervous system disorders   
Tingling, disorientation, dizziness, screening/run-in phase  1/45 (2.22%)  1
Skin and subcutaneous tissue disorders   
Pruritis/itching rash under CGMS site, screening/run-in phase  1/45 (2.22%)  1
Rash generalized over upper body at CGMS site, treatment phase  1/42 (2.38%)  1
Surgical and medical procedures   
Cholecystectomy, screening/run-in phase  1/45 (2.22%)  1
[1]
Also included vomiting and diarrhea in one case
[2]
Also included fever, cough, nasal congestion, and/or sore throat in some cases
[3]
Also included dizziness, fainting, and/or diarrhea in some cases
Our sample size and treatment durations were somewhat modest to compare severe hypoglycemic episodes and efficacy outcomes before and during treatment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Mark Van Natta
Organization: Johns Hopkins Data Coordinating Center
Phone: 410-614-1362
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01030341     History of Changes
Other Study ID Numbers: DK-GpCRC-3 GLUMIT-DG
U01DK073983 ( U.S. NIH Grant/Contract )
U01DK073975 ( U.S. NIH Grant/Contract )
U01DK073985 ( U.S. NIH Grant/Contract )
U01DK074035 ( U.S. NIH Grant/Contract )
U01DK074008 ( U.S. NIH Grant/Contract )
U01DK073974 ( U.S. NIH Grant/Contract )
U01DK074007 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2009
First Posted: December 11, 2009
Results First Submitted: April 5, 2017
Results First Posted: September 3, 2018
Last Update Posted: September 24, 2018