Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

Trial ID or NCT#

NCT01030341

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Linda Nguyen
Linda Nguyen
Gastroenterologist, Motility specialist
Clinical Professor, Medicine - Gastroenterology & Hepatology

View on ClinicalTrials.gov