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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

December 10, 2009
June 16, 2014
May 2011
November 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01030341 on ClinicalTrials.gov Archive Site
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 ]
To determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis, quality of life, gastric emptying, satiety, gastric myoelectrical activity, and autonomic function in diabetics with gastroparesis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
Pilot Study of the Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)

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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Gastroparesis
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
Experimental: CGMS and insulin pump
Continuous glucose monitoring in conjunction with insulin pump
Intervention: Device: CGMS and insulin pump
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01030341
DK-GpCRC-3 GLUMIT-DG, U01DK073983, U01DK073975, U01DK073985, U01DK074035, U01DK074008, U01DK073974, U01DK074007
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Study Director: Frank Hamilton, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP