Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

Study Overview
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Brief Summary
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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
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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
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Pilot Study of the Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)

Conditions
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Diabetic Gastroparesis

Intervention / Treatment
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* Device: CGMS and insulin pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGMS and insulin pump<br>Continuous glucose monitoring in conjunction with insulin pump | Device: CGMS and insulin pump<br>* Use of continuous glucose monitoring system and insulin pump<br>* Other names: Real-Time Continuous Glucose Monitoring System;|

What is the study measuring?
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Primary 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 | 

Secondary Outcome Measures

| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Gastroparesis