Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)
This study is currently recruiting participants.
Verified March 2013 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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: March 27, 2013
Last verified: March 2013
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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: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (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:
|
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: Lisa DiMaio 415.600.1155 DiMaioL@cpmcri.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 Wootten (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: Kristen Hairston, MD, MPH 336-713-7251 kghairst@wakehealth.edu | |
| Contact: Judy Hooker 336-713-7301 jhooker@wakehealth.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
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: | March 27, 2013 |
| 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 May 16, 2013