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Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)

Primary Purpose

Diabetic Gastroparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CGMS and insulin pump
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Gastroparesis focused on measuring Diabetes, Gastroparesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Pacific Medical Center
  • Stanford University
  • University of Michigan Medical Center
  • University of Mississippi Medical Center
  • Wake Forest University Health Sciences
  • Temple University Hospital
  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CGMS and insulin pump

Arm Description

Continuous glucose monitoring in conjunction with insulin pump

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 10, 2009
Last Updated
February 7, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01030341
Brief Title
Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
Keywords
Diabetes, Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CGMS and insulin pump
Arm Type
Experimental
Arm Description
Continuous glucose monitoring in conjunction with insulin pump
Intervention Type
Device
Intervention Name(s)
CGMS and insulin pump
Other Intervention Name(s)
Paradigm 722 Insulin pump, Real-Time Continuous Glucose Monitoring System
Intervention Description
Use of continuous glucose monitoring system and insulin pump
Primary Outcome Measure Information:
Title
Hypoglycemic Episodes
Description
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.
Time Frame
4 weeks screening vs 24 weeks follow-up
Secondary Outcome Measure Information:
Title
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Description
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.
Time Frame
Change from baseline (screening) vs 24 weeks of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Hamilton, MD
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Study Director
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5187
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/glumit/?query=GLUMIT
IPD Sharing URL
https://repository.niddk.nih.gov/studies/glumit/?query=GLUMIT
Links:
URL
https://jhuccs1.us/gpcrc/
Description
Click here for information on gastroparesis research

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Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

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