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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
Last Update Posted : March 21, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Diabetic Gastroparesis Device: CGMS and insulin pump

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 Design

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
Primary Completion Date : November 2014
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. The frequency of mild/moderate hypoglycemic episodes (glucose level less than 70 mg/dL) and number of severe hypoglycemic episodes at 12 and 24 week follow-up visits while using a combination of CGMS and insulin pump therapy. [ Time Frame: 12 and 24 weeks ]

Secondary Outcome Measures :
  1. To determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis, quality of life, satiety, gastric myoelectrical activity, and autonomic function in diabetics with gastroparesis [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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

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)
Study Director: Frank Hamilton, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information

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
Last Update Posted: March 21, 2016
Last Verified: March 2016

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

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