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Clinical Trial NCT01030341 (GLUMIT-DG) for Diabetic Gastroparesis is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG) 45
Clinical Trial NCT01030341 (GLUMIT-DG) was an interventional study for Diabetic Gastroparesis that is now completed. The study started on 1 May 2011, with plans to enroll 45 participants. Led by Johns Hopkins Bloomberg School of Public Health, the expected completion date was 1 January 2015. The latest data from ClinicalTrials.gov was last updated on 9 February 2022.
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
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.
Official Title
Pilot Study of the Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)
Conditions
Diabetic GastroparesisOther Study IDs
NCT ID Number
Start Date (Actual)
2011-05
Last Update Posted
2022-02-09
Completion Date (Estimated)
2015-01
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Diabetes
Gastroparesis
Gastroparesis
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCGMS and insulin pump Continuous glucose monitoring in conjunction with insulin pump | CGMS and insulin pump Use of continuous glucose monitoring system and insulin pump |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Hypoglycemic Episodes | 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. | 4 weeks screening vs 24 weeks follow-up |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score | 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. | Change from baseline (screening) vs 24 weeks of follow-up |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)No contact data.
7 Study Locations in 1 Countries
California
California Pacific Medical Center, San Francisco, California, 94115, United States
Stanford University, Stanford, California, 94305-5187, United States
Michigan
University of Michigan Medical Center, Ann Arbor, Michigan, 48109, United States
Mississippi
University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States
North Carolina
Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States
Pennsylvania
Temple University Hospital, Philadelphia, Pennsylvania, 19140, United States
Texas
Texas Tech University Health Sciences Center, El Paso, Texas, 79905, United States