Recruiting

Continuous Glucose Metrics

Sponsor:

Samita Garg

Code:

NCT06046833

Conditions

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 1

Gastroparesis With Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FreeStyle Libre 3 continuous glucose monitoring sensor

Nutritional drink

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 1

Gastroparesis With Diabetes Mellitus

Study ID

NCT06046833

Start date

Jan 8, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Patients with type 1 or type 2 diabetes and gastroparesis

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.

active comparator: Patients with type 1 or type 2 diabetes without gastroparesis

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

Interventions

FreeStyle Libre 3 continuous glucose monitoring sensor

The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute

Nutritional drink

Balanced nutritional drink (Boost plus 8 ounces/237 mL)

Primary outcome measure

  • Time-in-Range (TIR) [ Time Frame: 28 days of monitoring ]
  • Time-in-Tight Range (TITR) [ Time Frame: 28 days of monitoring ]
  • Time Below Range (TBR) [ Time Frame: 28 days of monitoring ]
  • Time Above Range (TAR) [ Time Frame: 28 days of monitoring ]
  • Metrics of Glucose Variability [ Time Frame: 28 days of monitoring ]

Central Contacts and Locations

Central contacts

Samita Garg, MD

216-444-2384gargs@ccf.org

Jorge Araujo-Duran, MD

216-444-7935araujoj@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Samita Garg, MD

216-444-2384gargs@ccf.org

Jorge Araujo-Duran, MD

216-444-7935araujoj@ccf.org

More Information

Sponsor

Samita Garg

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Gastroparesis
  • Diabetes
  • Continuous Glucose Monitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samita Garg on 2026-08-03.