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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01030341
First received: December 10, 2009
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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 Intervention
Diabetic Gastroparesis
Device: CGMS and insulin pump

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Frank Hamilton, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
No publications provided

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, U01DK073975, U01DK073985, U01DK074035, U01DK074008, U01DK073974, U01DK074007
Study First Received: December 10, 2009
Last Updated: June 16, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014