Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
NCT ID: NCT01030341
Last Updated: 2022-02-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2011-05-31
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
NCT06046833
Continuous Glucose Monitoring in Patients With Type 2 Diabetes
NCT00529815
Measuring and Monitoring Blood Glucose Levels Utilizing Non-invasive Blood Glucose Monitoring Device
NCT01508065
Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients
NCT03671161
Can Continuous Glucose Measurements Help Diabetic Patients Treated With an Implantated Pump?
NCT03048227
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CGMS and insulin pump
Continuous glucose monitoring in conjunction with insulin pump
CGMS and insulin pump
Use of continuous glucose monitoring system and insulin pump
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CGMS and insulin pump
Use of continuous glucose monitoring system and insulin pump
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frank Hamilton, MD
Role: STUDY_DIRECTOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
California Pacific Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for information on gastroparesis research
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U01DK074008 GLUMIT-DG
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.