GLUMIT-DG: Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
Study Details
Study Description
Brief Summary
A pilot study to assess the safety, feasibility, and potential (uncontrolled) efficacy of continuous glucose monitoring (CGMS) in conjunction with an insulin pump to improve glycemic control for treatment of type 1 and type 2 diabetic patients with gastroparesis
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This multicenter, uncontrolled, open label treatment study is to assess the safety of CGMS in guiding insulin pump therapy for 24 weeks by measuring mild, moderate, and severe hypoglycemic episodes in patients with type 1 and type 2 diabetes and gastroparesis.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: CGMS and insulin pump Continuous glucose monitoring in conjunction with insulin pump |
Device: CGMS and insulin pump
Use of continuous glucose monitoring system and insulin pump
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Hypoglycemic Episodes [4 weeks screening vs 24 weeks follow-up]
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.
Secondary Outcome Measures
- Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score [Change from baseline (screening) vs 24 weeks of follow-up]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 - 70 years old at registration
-
Type 1 or Type 2 diabetes mellitus for at least 2 years
-
Symptoms of gastroparesis (nausea, vomiting, early satiety, bloating, fullness, discomfort) for at least 1 year prior to registration
-
Gastroparesis Cardinal Symptom Index (GCSI) score of 18
-
Delayed gastric emptying on gastric scintigraphy within 1 year of registration, defined as greater than 60% retention at 2 hours or greater than 10% retention at 4 hours
-
Hemoglobin A1c of at least 8.0% at registration regardless of current therapy. Individuals already receiving diabetes therapy via an insulin pump will be eligible for study participation if, in the opinion of the investigators, he/she may acquire additional benefit from continuous glucose monitoring that might improve glycemic control
-
Normal upper endoscopy within 1 year of registration
-
No clinical or imaging evidence of obstruction
-
Successful mastering of use of CGMS during the run-in period
Exclusion Criteria:
-
Prior gastric surgery including fundoplication
-
Other systemic disease potentially causative of gastrointestinal symptoms
-
Acute or chronic renal insufficiency with creatinine >1.5 mg/dL
-
Psychiatric disease or eating disorder
-
Pregnancy
-
Any other condition which, in the opinion of the investigators, would impede compliance or hinder completion of the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | California Pacific Medical Center | San Francisco | California | United States | 94115 |
2 | Stanford University | Stanford | California | United States | 94305-5187 |
3 | University of Michigan Medical Center | Ann Arbor | Michigan | United States | 48109 |
4 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
5 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
6 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
7 | Texas Tech University Health Sciences Center | El Paso | Texas | United States | 79905 |
Sponsors and Collaborators
- Johns Hopkins Bloomberg School of Public Health
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Study Director: Frank Hamilton, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- U01DK074008 GLUMIT-DG
- U01DK073983
- U01DK073975
- U01DK073985
- U01DK074035
- U01DK074008
- U01DK073974
- U01DK074007
Study Results
Participant Flow
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 Detail | 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 |
---|---|
Arm/Group Description | 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 |
COMPLETED | 42 |
NOT COMPLETED | 3 |
Baseline Characteristics
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | Continuous glucose monitoring in conjunction with insulin pump CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump |
Overall Participants | 45 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
45
(12)
|
Sex: Female, Male (Count of Participants) | |
Female |
31
68.9%
|
Male |
14
31.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
11
24.4%
|
Not Hispanic or Latino |
34
75.6%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
45
100%
|
Known diabetes duration (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
21
(11)
|
Body mass index (kg/m^2) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [kg/m^2] |
29
(8)
|
Hemoglobin A1c (percentage) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [percentage] |
9.4
(1.4)
|
2 hr gastric retention (percentage) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [percentage] |
63
(20)
|
4 hr gastric retention (percentage) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [percentage] |
32
(20)
|
GCSI score (units on a scale) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [units on a scale] |
3.3
(0.8)
|
PAGI-QOL (units on a scale) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [units on a scale] |
2.4
(1.1)
|
Volume of Water consumed for water load satiety test (mL) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [mL] |
430
(207)
|
Volume consumed in a liquid nutrient satiety test (mL) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [mL] |
420
(258)
|
Outcome Measures
Title | Hypoglycemic Episodes |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
44 patients had non-missing data during screening phase and 37 had non-missing data during treatment phase |
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | Continuous glucose monitoring in conjunction with insulin pump CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump |
Measure Participants | 44 |
Screening phase, hypoglycemia / person-week |
1.9
|
Treatment phase, hypoglycemia / person-week |
2.2
|
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 (legacy) | |
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 |
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 (legacy) | |
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 |
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 (legacy) | |
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 |
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 (legacy) | |
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 |
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 (legacy) | |
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 |
Title | Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | Continuous glucose monitoring in conjunction with insulin pump CGMS and insulin pump: Use of continuous glucose monitoring system and insulin pump |
Measure Participants | 45 |
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)
|
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 (legacy) | |
Comments | Mean change = 0 | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | paired t-test | |
Comments |
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 (legacy) | |
Comments | Mean change = 0 | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | paired t-test | |
Comments |
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 (legacy) | |
Comments | Mean change = 0 | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | paired t-test | |
Comments |
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 (legacy) | |
Comments | Mean change = 0 | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | paired t-test | |
Comments |
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 (legacy) | |
Comments | Mean change = 0 | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | paired t-test | |
Comments |
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 (legacy) | |
Comments | Mean change = 0 | |
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | paired t-test | |
Comments |
Adverse Events
Time Frame | ||
---|---|---|
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 | |
Arm/Group Description | 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 (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
All Participants | ||
Affected / at Risk (%) | # Events | |
Total | 16/45 (35.6%) | |
Cardiac disorders | ||
Heart attack, screening/run-in phase | 1/45 (2.2%) | 1 |
Eye disorders | ||
Retinal detachment, screening/run-in phase | 1/45 (2.2%) | 1 |
Gastrointestinal disorders | ||
Severe gastroparesis exacerbation, screening/run-in phase | 1/45 (2.2%) | 2 |
Severe gastroparesis exacerbation, treatment phase | 1/42 (2.4%) | 1 |
Abdominal pain, nausea, vomiting, screening/run-in phase | 1/45 (2.2%) | 1 |
Abdominal pain, nausea, vomiting, treatment phase | 3/42 (7.1%) | 3 |
General disorders | ||
Death of unknown cause, screening/run-in phase | 1/45 (2.2%) | 1 |
Metabolism and nutrition disorders | ||
Severe hypoglycemic events, screening/run-in phase | 2/45 (4.4%) | 2 |
Severe hypoglycemic events, treatment phase | 6/42 (14.3%) | 6 |
Severe hyperglycemic events, treatment phase | 3/42 (7.1%) | 3 |
Nervous system disorders | ||
Pain, numbness, paresthesia in hands, screening/run-in phase | 1/45 (2.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
All Participants | ||
Affected / at Risk (%) | # Events | |
Total | 12/45 (26.7%) | |
Ear and labyrinth disorders | ||
Bilateral otitis externa, treatment phase | 1/42 (2.4%) | 2 |
Gastrointestinal disorders | ||
Non-severe gastroparesis exacerbation, screening/run-in phase | 2/45 (4.4%) | 2 |
Non-severe gastroparesis exacerbation, treatment phase | 2/42 (4.8%) | 5 |
Abdominal pain, nausea, vomiting, screening/run-in phase | 2/45 (4.4%) | 5 |
Abdominal pain, nausea, vomiting, treatment phase | 2/42 (4.8%) | 2 |
Metabolism and nutrition disorders | ||
Non-severe hyperglycemia, screening/run-in phase | 1/45 (2.2%) | 1 |
Nervous system disorders | ||
Tingling, disorientation, dizziness, screening/run-in phase | 1/45 (2.2%) | 1 |
Skin and subcutaneous tissue disorders | ||
Pruritis/itching rash under CGMS site, screening/run-in phase | 1/45 (2.2%) | 1 |
Rash generalized over upper body at CGMS site, treatment phase | 1/42 (2.4%) | 1 |
Surgical and medical procedures | ||
Cholecystectomy, screening/run-in phase | 1/45 (2.2%) | 1 |
Limitations/Caveats
More Information
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 |
mvannat1@jhu.edu |
- U01DK074008 GLUMIT-DG
- U01DK073983
- U01DK073975
- U01DK073985
- U01DK074035
- U01DK074008
- U01DK073974
- U01DK074007