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Keep this study
Lead
Johns Hopkins Bloomberg School of Public Health
With
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
