Trial Search Results

Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Stanford Investigator(s):

Intervention(s):

  • Device: CGMS and insulin pump

Phase:

N/A

Eligibility


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

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting