N/A
N=45
Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
Diabetic Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT01030341 ↗Enrolled (actual)
45
Serious AEs
35.6%
Results posted
Sep 2018
Primary outcome: Primary: Hypoglycemic Episodes — 1.9; 2.2 event rate per person-week — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CGMS and insulin pump (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoglycemic Episodes |
1.9; 2.2 | <0.0001 sig |
| SECONDARY Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score |
-7.2; -7.1; -0.6; -0.8; 0.7; 0.7 | <0.0001 sig |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01030341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.