Early access
Sign in
Taking people in United StatesNo phase

Tracking Blood Sugar With a Sensor in Diabetes and Stomach Paralysis

Tests a glucose sensor in adults with diabetes, with and without gastroparesis.

Key facts

Who runs it
Samita Garg
Where
Cleveland, United StatesSee the site
Trial code
Registry title
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Status
Recruiting
People taking part
50 people, planned
Started
8 Jan 2024
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • FreeStyle Libre 3 continuous glucose monitoring sensor
  • Nutritional drink
Record updated
3 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 or type 2 diabetes, with or without gastroparesis, to compare glucose readings from a continuous glucose monitor.

Age
Over 18 years
Sex
All sexes can join
Disease stage
Type 1 or type 2 diabetes for at least one year. Hemoglobin A1c ≤11% (97 mmol/mol) within the last 6 months. For the gastroparesis group: symptoms for at least 3 months and delayed stomach emptying shown on a test in the past five years.
Earlier treatment
No opiates or GLP-1 agonists (Ozempic, Wegovy, Mounjaro, Trulicity) in the last 2 weeks. No motility medicines (such as Reglan or Domperidone) in the last week.
Biomarker or test result
Normal thyroid-stimulating hormone (TSH) within the last year. For the gastroparesis group: more than 10% food retained at 4 hours, or stomach transit time over 4 hours.

Main reasons for not taking part

  • Hemoglobin A1c above 11% (97 mmol/mol) at enrollment
  • Advanced kidney disease, advanced liver disease or advanced heart disease
  • Pregnancy, or not taking adequate precautions against pregnancy
  • History of gastric surgery, or a transplant
  • Use of steroids, immunomodulators, opiates or illicit drugs

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Post-transplant patients
  • 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
  • Patient previously participated in the study
  • Advanced and significant cardiovascular disease or unstable angina
  • History of gastric surgery
  • Patients with symptoms secondary to celiac disease (e.g. diarrhea, nausea, vomiting, abdominal pain) at the time of the enrollment
  • 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 liver disease that may affect glucose profiles
  • Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles
  • Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days
  • Clinically significant abnormalities on upper GI endoscopy
  • Presence of imaging evidence of gastric or intestinal obstruction

Where in United States

  • Cleveland Clinic FoundationCleveland, United StatesContact: Samita Garg, MDTaking people

About the trial

What the trial wants to find out

A pilot study to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) between patients with diabetes and gastroparesis and those with diabetes without gastroparesis.

The 2 groups in the trial

  • Patients with type 1 or type 2 diabetes and gastroparesisTreatment being tested

    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.

    Treatment: FreeStyle Libre 3 continuous glucose monitoring sensor and Nutritional drink

  • Patients with type 1 or type 2 diabetes without gastroparesisExisting treatment, for comparison

    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

    Treatment: FreeStyle Libre 3 continuous glucose monitoring sensor and Nutritional drink

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Glucose Metrics Using Freestyle Libre 3 Real-Time Continuous Glucose Monitor (rtCGM) in Patients With Gastroparesis in Type 1 or Type 2 Diabetes: Investigator Initiated Pilot Study
Plain-language title
Tracking Blood Sugar With a Sensor in Diabetes and Stomach ParalysisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 August 2026