Diabetic GastroparesisGLUMIT-DGNCT01030341
Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis
A study testing CGMS and insulin pump in people with Diabetic Gastroparesis, run by Johns Hopkins Bloomberg School of Public Health at 7 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- CGMS and insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Temple University Hospital
Philadelphia, Pennsylvania, 19140
California Pacific Medical Center
San Francisco, California, 94115
Stanford University
Stanford, California, 94305-5187
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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
Read the 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.
- Conditions
- Diabetic Gastroparesis
- Being tested
- CGMS and insulin pump
- Keywords
- Diabetes, Gastroparesis
- Medical subject headings
- Diabetes Mellitus, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMS and insulin pumpDevice
Also called Paradigm 722 Insulin pump, Real-Time Continuous Glucose Monitoring System
Use of continuous glucose monitoring system and insulin pump
| Study group | Role | What they receive |
|---|---|---|
| CGMS and insulin pump | Experimental | Continuous glucose monitoring in conjunction with insulin pump Receives: Device: CGMS and insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To determine the efficacy of CGMS guided insulin pump therapy on symptoms of gastroparesis as assessed by GCSI total score and mean score and quality of life as assessed by PAGI-QOL score in diabetics with gastroparesis.
The outcome is assessed using the self-reported total GCSI score, which is computed as the average of the 3 subscores on the GCSI survey: 3-item postprandial fullness/early satiety subscore, the nausea/vomiting subscore (average of 3-items: nausea, retching, vomiting), and bloating subscore (average of 2-items: bloating, stomach visibly larger). Each item is scored from 0 (no) to 5 (very severe) symptoms in the past 2-weeks; the total score ranges from 0 to 5.
The self-reported PAGI-QOL total score which comprises 30 items scored from 0 (none of the time) to 5 (all of the time) the participant's QOL has been affected in the last 2 weeks.The total score is the mean of the 5 subscale scores and ranges from 0 (lowest QOL) to 5 (highest QOL) in past 2-weeks.
Measured: Change from baseline (screening) vs 24 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startMay 2011
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Hamilton, MD, Study director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030341
- Sponsor's protocol ID
- U01DK074008 GLUMIT-DG
- Other IDs
- U01DK073983, U01DK073975, U01DK073985, U01DK074035, U01DK074008, U01DK073974, U01DK074007
- Acronym
- GLUMIT-DG
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2009
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/glumit/?query=GLUMIT
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)
- ClinicalTrials.gov ID
- NCT01030341
- Acronym / sponsor ID
- GLUMIT-DG / U01DK074008 GLUMIT-DG
- Conditions
- Diabetic Gastroparesis
- Keywords
- Diabetes, Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Posted 4 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGMS and insulin pump | Experimental | Device: CGMS and insulin pumpContinuous glucose monitoring in conjunction with insulin pump |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMS and insulin pumpAlso: Paradigm 722 Insulin pump, Real-Time Continuous Glucose Monitoring SystemUse of continuous glucose monitoring system and insulin pump | Device | CGMS and insulin pump |
Primary outcome
Hypoglycemic Episodes
Time frame: 4 weeks screening vs 24 weeks follow-up
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.
1 secondary outcome
Change in Gastroparesis Cardinal Symptom Index (GCSI) Total and Mean Score and Patient Assessed Gastro-Intestinal Quality of Life (PAGI-QOL) Score
Time frame: Change from baseline (screening) vs 24 weeks of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for information on gastroparesis researchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/glumit/?query=GLUMIT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Hamilton, MD study director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGMS and insulin pump in people with Diabetic Gastroparesis, run by Johns Hopkins Bloomberg School of Public Health at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemic Episodes (time frame: 4 weeks screening vs 24 weeks follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.