Clinical trial NCT01030341: Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Gastroparesis
Keywords: Diabetes
Gastroparesis
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-12-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hypoglycemic Episodes
timeFrame: 4 weeks screening vs 24 weeks follow-up
Secondary outcomes:
measure: Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
timeFrame: Change from baseline (screening) vs 24 weeks of follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Frank Hamilton, MD
role: STUDY_DIRECTOR
References: