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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

Must not have

Advanced chronic kidney disease (serum creatinine of >2 mg/dL or estimated glomerular filtration rate (eGFR) <30mL/min/1.73m² using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

Advanced and significant cardiovascular disease or unstable angina

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely reduced.

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I have severe heart disease or unstable chest pain.

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I have had surgery on my stomach.

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I have been diagnosed with celiac disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metrics of Glucose Variability

Time Above Range (TAR)

Time Below Range (TBR)

+2 more

Secondary study objectives

Hyperglycemia episodes

Hypoglycemia episodes

Other study objectives

GCSI questionnaire

GIQLI questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 7Eligibility criteria met