Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

Diabetic Gastroparesis Clinical Trial

— GLUMIT-DG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030341
• Other study ID #: U01DK074008 GLUMIT-DG
• Secondary ID: U01DK073983U01DK
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

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

External Links

•   Click here for information on gastroparesis research