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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Gastroparesis With Diabetes Mellitus
• Interventions: Device: FreeStyle Libre 3 continuous glucose monitoring sensor; Other: Nutritional drink

• Registration Number: NCT06046833
• Lead Sponsor: Samita Garg

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.

Detailed Description

Investigators will analyze and compare various Glucose Metrics (GM) derived from a Continuous Glucose Monitor (CGM) between individuals with diabetes and gastroparesis and those with diabetes without gastroparesis over a period of 28 days and during two standardized meal challenge visits. Furthermore, the investigators aim to assess whether there is an association between gastroparesis and GM parameters.

The objective is to propose a new tool (Diabetic Gastroparesis Index or Score) to assess for early gastroparesis in patients with diabetes using the identified and analyzed GM. This may help patients and providers to recognize gastroparesis early and facilitate necessary medical interventions.

Hyperglycemia and hypoglycemia episodes will be monitored throughout the study for both groups and their association with GM and gastroparesis will be evaluated.

The Gastroparesis Cardinal Symptom Index (GCSI) and the Gastrointestinal Quality of Life Index (GIQLI) questionnaires will be performed to assess the association of gastroparesis symptoms with GM.

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-21
• Study Start: 2024-01-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with type 1 or type 2 diabetes and gastroparesis	Nutritional drink	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.
Patients with type 1 or type 2 diabetes and gastroparesis	FreeStyle Libre 3 continuous glucose monitoring sensor	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.
Patients with type 1 or type 2 diabetes without gastroparesis	FreeStyle Libre 3 continuous glucose monitoring sensor	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
Patients with type 1 or type 2 diabetes without gastroparesis	Nutritional drink	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

Primary Outcome Measures

Name	Time	Method
Metrics of Glucose Variability	28 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)
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-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-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 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).

Secondary Outcome Measures

Name	Time	Method
Hyperglycemia episodes	28 days of monitoring	At least 15 minutes or longer of Time-Above Range (TAR) 181-250 mg/dL (Level 1 hyperglycemia) and \>250 mg/dl (Level 2 hyperglycemia)
Hypoglycemia episodes	28 days of monitoring	At least 15 minutes or longer of Time-Below-Range (TBR) 54-69 mg/dL (Level 1 hypoglycemia) or \<54 mg/dL (Level 2 hypoglycemia)

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States