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

NCT06046833 | Recruiting DMC FDA Device

• 1 other identifier: 23-594
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Gastroparesis; Diabetes; Continuous Glucose Monitor

Outcome Measures

Primary Outcomes (5)

• Time-in-Range (TIR)

  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.

  28 days of monitoring

• Time-in-Tight Range (TITR)

  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.

  28 days of monitoring

• Time Below Range (TBR)

  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)

  28 days of monitoring

• Time Above Range (TAR)

  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).

  28 days of monitoring

• Metrics of Glucose Variability

  * 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)

  28 days of monitoring

Secondary Outcomes (2)

• Hyperglycemia episodes

  28 days of monitoring

• Hypoglycemia episodes

  28 days of monitoring

Other Outcomes (2)

• GCSI questionnaire

  Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days)

• GIQLI questionnaire

  Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days)

Study Arms (2)

Patients with type 1 or type 2 diabetes and gastroparesis

EXPERIMENTAL

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.

Device: FreeStyle Libre 3 continuous glucose monitoring sensor; Other: Nutritional drink

Patients with type 1 or type 2 diabetes without gastroparesis

ACTIVE COMPARATOR

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

Device: FreeStyle Libre 3 continuous glucose monitoring sensor; Other: Nutritional drink

Interventions

FreeStyle Libre 3 continuous glucose monitoring sensor DEVICE

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

Also known as: FreeStyle Libre 3 system

Patients with type 1 or type 2 diabetes and gastroparesis; Patients with type 1 or type 2 diabetes without gastroparesis

Nutritional drink OTHER

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

Also known as: Boost plus

Patients with type 1 or type 2 diabetes and gastroparesis; Patients with type 1 or type 2 diabetes without gastroparesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samita Garg: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Gastroparesis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samita Garg, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samita Garg, MD

CONTACT

216-444-2384; gargs@ccf.org

Jorge Araujo-Duran, MD

CONTACT

216-444-7935; araujoj@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Same intervention for two cohorts

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start: January 8, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)