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Continuous Glucose Monitoring for Gastroparesis in Diabetes

N/A

Recruiting

Led By Samita Garg, MD

Research Sponsored by Samita Garg

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 3 months requiring ER visit or hospitalization

In patients with gastroparesis, documented delayed gastric emptying on scintigraphy and/or wireless motility capsule (Smart Pill) as defined by greater than 10% retention at 4 hours or greater than 4-hour gastric transit time (GTT) in the past five years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 2 - day 5 (-3/+6 days), and visit 4 - day 25 (-7/+3 days)

Awards & highlights

Study Summary

This trial compares glucose control in people with diabetes, with and without gastroparesis, to see if one group fares better.

Who is the study for?

This trial is for adults over 18 with type 1 or type 2 diabetes and a recent Hemoglobin A1c ≤11%. It's specifically for those who've had diabetes for at least a year without severe incidents in the past three months. Participants should have gastroparesis symptoms for three months, confirmed by tests, and must use a smartphone compatible with the LibreView App.Check my eligibility

What is being tested?

The study is testing how well the FreeStyle Libre 3 sensor monitors blood sugar levels in patients with both diabetes and gastroparesis compared to diabetic patients without gastroparesis. It also looks at how nutritional drinks affect these metrics.See study design

What are the potential side effects?

Potential side effects may include skin irritation from the glucose sensor adhesive, inaccurate readings leading to mismanagement of insulin doses, and possible digestive discomfort from the nutritional drink.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had severe diabetes complications requiring hospital visits in the last 3 months.

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My tests show slow stomach emptying in the last 5 years.

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I have been diagnosed with diabetes (type 1 or 2) for at least a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2 - day 5 (-3/+6 days), and visit 4 - day 25 (-7/+3 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 2 - day 5 (-3/+6 days), and visit 4 - day 25 (-7/+3 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 - day 5 (-3/+6 days), and visit 4 - day 25 (-7/+3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Metrics of Glucose Variability

Time Above Range (TAR)

Time Below Range (TBR)

+2 more

Secondary outcome measures

Hyperglycemia episodes

Hypoglycemia episodes

Other outcome measures

GCSI questionnaire

GIQLI questionnaire

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patients with type 1 or type 2 diabetes and gastroparesisExperimental Treatment2 Interventions

Both groups will have the same intervention. FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge.

Group II: Patients with type 1 or type 2 diabetes without gastroparesisActive Control2 Interventions

Both groups will have the same intervention. FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Samita GargLead Sponsor

Samita Garg, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in the experiment for participants?

"According to the latest information published on clinicaltrials.gov, recruitment for this specific study is not open at present time. The trial was first posted in October of 2023 and last updated six months later; however, there are 1540 other studies actively seeking participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

Samita Garg 2024. "Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046833.

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