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Continuous Glucose Monitoring in Diabetes and Gastroparesis

This study is looking at how glucose (sugar) levels change in people with type 1 or type 2 diabetes, especially those who also have gastroparesis (a condition where the stomach empties too slowly). Researchers will use a FreeStyle Libre 3 continuous glucose monitoring sensor, a small device that measures glucose every minute, to track these levels for 28 days. They will also give participants a nutritional drink (Boost plus) during two visits. The goal is to see if there are specific patterns in glucose levels that could help identify gastroparesis early in people with diabetes. This could lead to a new tool to help doctors recognize and treat gastroparesis sooner. The study plans to enroll 50 participants who are over 18, have had diabetes for at least a year, and have a Hemoglobin A1c (a measure of average blood sugar) of 11% or less.

Study design
This is an interventional pilot study involving 50 participants with type 1 or type 2 diabetes, comparing glucose metrics between those with and without gastroparesis.
What's involved
You would wear a FreeStyle Libre 3 sensor for 28 days and attend two visits where you will consume a nutritional drink.
Compensation
Not stated in the trial record.
Follow-up
Your glucose levels will be monitored for 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06046833

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

Recruiting
NAAges 18+InterventionalScreening
Samita Garg
~50 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:FreeStyle Libre 3 continuous glucose monitoring sensorNutritional drink

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time-in-Range (TIR)
Measured over 28 days of monitoring
+4 more outcomes measured

Conditions

Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Gastroparesis With Diabetes Mellitus

Explore related trials

GastroparesisType 1 Diabetes MellitusType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Samita Garg, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Samita Garg, MD
[email protected]
216-444-2384
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Over the age of 18 years.
Hemoglobin A1c ≤11% within the last 6 months.
Patients with diagnosis of type 1 Diabetes or type 2 Diabetes for at least one year.
Normal thyroid-stimulating hormone (TSH) within the last year.
No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 2 weeks requiring ER visit or hospitalization.
Symptoms of gastroparesis have been present for at least the past 3 months, in patients with gastroparesis.
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.
Patients using a Smartphone (iPhone or Android) compatible with LibreView App.

Exclusion

Hemoglobin A1c of \>11% at enrollment.
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.
Advanced liver disease that may affect glucose profiles.
Post-transplant patients.
History of gastric surgery.
Patients with symptoms secondary to celiac disease (e.g. diarrhea, nausea, vomiting, abdominal pain) at the time of the enrollment.
Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days.
Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles.
Patients on opiates or glucagon-like peptide-1 (GLP-1) agonists (Ozempic, Wegovy, Mounjaro, Trulicity). If previously taking these medications, patients can be enrolled after 2 weeks of the last dose.
Patient on recreational or illicit drugs (i.e., marijuana, opiates, cocaine, etc.).
Patients on motility medications such as Reglan (Metoclopramide), Motegrity (Prucalopride), Cisapride, Domperidone, Erythromycin. If previously taking any of these medications, patients can be enrolled after 1 week of the last dose.
Clinically significant abnormalities on upper GI endoscopy.
Presence of imaging evidence of gastric or intestinal obstruction.
Patient previously participated in the study.

What this trial measures

  • Time-in-Range (TIR)28 days of monitoring

    Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) in target glucose range 70-180 mg/dL.

  • Time-in-Tight Range (TITR)28 days of monitoring

    Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) in target glucose range 70-140 mg/dL.

  • Time Below Range (TBR)28 days of monitoring

    Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) with glucose \<70 mg/dL (including readings \<54 mg/dL)

  • Time Above Range (TAR)28 days of monitoring

    Percentage of time spent per day (and estimated actual amount of time in hours or minutes per day) with \>180 mg/dL (including readings \>250 mg/dL).

  • Metrics of Glucose Variability28 days of monitoring

    * Standard Deviation (SD) * Coefficient of Variation (CV) * Glucose Management Indicator (GMI) * Mean Amplitude of Glucose Excursion (MAGE) * Mean Of Daily Differences (MODD) * Mean Indices of Meal Excursion (MIME) * Continuous overall net glycemic action (CONGA) * Low Blood Glucose Index (LBGI) * High Blood Glucose Index (HBGI)