Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis - Full Text View

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

This study is currently recruiting participants.

Verified October 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

First Received on December 10, 2009. Last Updated on October 31, 2011 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT01030341

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:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin Insulin beef Dextrose

U.S. FDA Resources

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:	October 2012
Estimated Primary Completion Date:	October 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030341

Contacts

Contact: James Tonascia, PhD	410-955-3704	jtonasci@jhsph.edu
Contact: Aynur Unalp-Arida, MD, PhD	410-614-4851	aunalp@jhsph.edu

Locations

United States, California
California Pacific Medical Center	Recruiting
San Francisco, California, United States, 94115
Contact: William Snape, MD 415-516-9127 snapew@sutterhealth.org
Contact: Brian Macapinlac 415.600.1367 MacapiB@sutterhealth.org
Sub-Investigator: William Snape, MD
Stanford University	Recruiting
Stanford, California, United States, 94305-5187
Contact: Pankaj J Pasricha, MD 650-725-3362 Pasricha@stanford.edu
Contact: Nighat Ullah (650) 723-3567 nullah@stanford.edu
Principal Investigator: Pankaj J Pasricha, MD
United States, Michigan
University of Michigan Medical Center	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: William L Hasler, MD 734-936-8644 whasler@umich.edu
Contact: Nara Wooten (734) 615-6723 smao@umich.edu
Principal Investigator: William L Hasler, MD
United States, Mississippi
University of Mississippi Medical Center	Recruiting
Jackson, Mississippi, United States, 39216
Contact: Thomas L Abell, MD 601-815-3463 tabell@umc.edu
Contact: Margaret Smith, RN (601) 984-4540 marsmith@umc.edu
Principal Investigator: Thomas L Abell, MD
United States, North Carolina
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jorge Calles, MD 336-713-7251 jcalles@wfubmc.edu
Contact: Judy Hooker 336-713-7301 jhooker@wfubmc.edu
Principal Investigator: Kenneth L Koch, MD
Sub-Investigator: Jorge Calles, MD
United States, Pennsylvania
Temple University Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Henry P Parkman, MD 215-707-7579 henry.parkman@temple.edu
Contact: Kellie Simmons, CRNP 215-707-5477 kellie.simmons@temple.edu
Principal Investigator: Henry P Parkman, MD
United States, Texas
Texas Tech University Health Sciences Center	Recruiting
El Paso, Texas, United States, 79905
Contact: Richard W McCallum, MD 915-545-6618 richard.mccallum@ttuhsc.edu
Contact: Irene Sarosiek, MD (915) 545-6618 irene.sarosiek@ttuhsc.edu
Principal Investigator: Richard W McCallum, MD
Sub-Investigator: Irene Sarosiek, MD

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)

More Information

Additional Information:

Click here for information on gastroparesis research This link exits the ClinicalTrials.gov site

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:	October 31, 2011
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 21, 2012