Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis

NCT01030341 | Completed Results DMC

• 8 other identifiers: U01DK074008 GLUMIT-DGU01DK073983U01DK073975U01DK073985U01DK074035U01DK074008U01DK073974U01DK074007
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

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

Conditions

Diabetic Gastroparesis

Keywords

Diabetes; Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Hypoglycemic Episodes

  The incidence rate (events / person-week) of mild/moderate (glucose level \< 70 mg/dL) and severe (glucose \< 50 mg/dL) hypoglycemic episodes during screening vs 24 week of follow-up visits while using a combination of continuous glucose monitoring system (CGMS) and insulin pump therapy.

  4 weeks screening vs 24 weeks follow-up

Secondary Outcomes (1)

• Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score

  Change from baseline (screening) vs 24 weeks of follow-up

Study Arms (1)

CGMS and insulin pump

EXPERIMENTAL

Continuous glucose monitoring in conjunction with insulin pump

Device: CGMS and insulin pump

Interventions

CGMS and insulin pump DEVICE

Use of continuous glucose monitoring system and insulin pump

Also known as: Paradigm 722 Insulin pump, Real-Time Continuous Glucose Monitoring System

CGMS and insulin pump

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (7)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305-5187, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Related Links

• Click here for information on gastroparesis research

MeSH Terms

Conditions

Diabetes Mellitus; Gastroparesis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our sample size and treatment durations were somewhat modest to compare severe hypoglycemic episodes and efficacy outcomes before and during treatment.

Results Point of Contact

• Title: Mark Van Natta
• Organization: Johns Hopkins Data Coordinating Center

mvannat1@jhu.edu

410-614-1362

Study Officials

• Frank Hamilton, MD

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: May 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 9, 2022
• Results First Posted: September 4, 2018

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)