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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01030341
Other study ID # U01DK074008 GLUMIT-DG
Secondary ID U01DK073983U01DK
Status Completed
Phase N/A
First received
Last updated
Start date May 2011
Est. completion date January 2015

Study information

Verified date February 2022
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CGMS and insulin pump
Use of continuous glucose monitoring system and insulin pump

Locations

Country Name City State
United States University of Michigan Medical Center Ann Arbor Michigan
United States Texas Tech University Health Sciences Center El Paso Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States Temple University Hospital Philadelphia Pennsylvania
United States California Pacific Medical Center San Francisco California
United States Stanford University Stanford California
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypoglycemic Episodes The incidence rate (events / person-week) of mild/moderate (glucose level < 70 mg/dL) and severe (glucose < 50 mg/dL) hypoglycemic episodes during screening vs 24 week of follow-up visits while using a combination of continuous glucose monitoring system (CGMS) and insulin pump therapy. 4 weeks screening vs 24 weeks follow-up
Secondary Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score To determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis as assessed by GCSI total score and mean score and quality of life as assessed by PAGI-QOL score in diabetics with gastroparesis.
The outcome is assessed using the self-reported total GCSI score, which is computed as the average of the 3 subscores on the GCSI survey: 3-item postprandial fullness/early satiety subscore, the nausea/vomiting subscore (average of 3-items: nausea, retching, vomiting), and bloating subscore (average of 2-items: bloating, stomach visibly larger). Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the total score ranges from 0 to 5.
The self-reported PAGI-QOL total score which comprises 30 items scored from 0 (none of the time) to 5 (all of the time) the participant's QOL has been affected in the last 2 weeks.The total score is the mean of the 5 subscale scores and ranges from 0 (lowest QOL) to 5 (highest QOL) in past 2-weeks.
Change from baseline (screening) vs 24 weeks of follow-up
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