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

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ClinicalTrials.gov Identifier: NCT01030341
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : September 3, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

Condition or disease Intervention/treatment Phase
Diabetic Gastroparesis Device: CGMS and insulin pump Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CGMS and insulin pump
Continuous glucose monitoring in conjunction with insulin pump
Device: CGMS and insulin pump
Use of continuous glucose monitoring system and insulin pump
Other Names:
  • Paradigm 722 Insulin pump
  • Real-Time Continuous Glucose Monitoring System




Primary Outcome Measures :
  1. Hypoglycemic Episodes [ Time Frame: 4 weeks screening vs 24 weeks follow-up ]
    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 :
  1. Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score [ Time Frame: Change from baseline (screening) vs 24 weeks of follow-up ]

    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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030341


Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
Stanford University
Stanford, California, United States, 94305-5187
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Director: Frank Hamilton, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01030341     History of Changes
Other Study ID Numbers: DK-GpCRC-3 GLUMIT-DG
U01DK073983 ( U.S. NIH Grant/Contract )
U01DK073975 ( U.S. NIH Grant/Contract )
U01DK073985 ( U.S. NIH Grant/Contract )
U01DK074035 ( U.S. NIH Grant/Contract )
U01DK074008 ( U.S. NIH Grant/Contract )
U01DK073974 ( U.S. NIH Grant/Contract )
U01DK074007 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2009    Key Record Dates
Results First Posted: September 3, 2018
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be deposited with the NIDDK Data Repository at the end of the funding cycle. https://www.niddkrepository.org/home/

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Diabetes
Gastroparesis

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs