Pilot Study of the Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 7
- Primary Endpoint
- Hypoglycemic Episodes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CGMS and insulin pump
Continuous glucose monitoring in conjunction with insulin pump
Intervention: CGMS and insulin pump (Device)
Outcomes
Primary Outcomes
Hypoglycemic Episodes
Time Frame: 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 Outcomes
- 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)