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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Gastroparesis With Diabetes Mellitus
• Intervention / Treatment: Device: FreeStyle Libre 3 continuous glucose monitoring sensor; Other: Nutritional drink

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samita Garg, MD; Phone Number: 216-444-2384; Email: gargs@ccf.org
• Study Contact Backup: Name: Jorge Araujo-Duran, MD; Phone Number: 216-444-7935; Email: araujoj@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Samita Garg, MD; Phone Number: 216-444-2384; Email: gargs@ccf.org
      • Contact: Jorge Araujo-Duran, MD; Phone Number: 216-444-7935; Email: araujoj@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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; Other Names: FreeStyle Libre 3 system; Other: Nutritional drink; Balanced nutritional drink (Boost plus 8 ounces/237 mL); Other Names: Boost plus
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	Device: 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; Other Names: FreeStyle Libre 3 system; Other: Nutritional drink; Balanced nutritional drink (Boost plus 8 ounces/237 mL); Other Names: Boost plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperglycemia episodes	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)	28 days of monitoring
Hypoglycemia episodes	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)	28 days of monitoring

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GCSI questionnaire	9 symptoms item questionnaire with a 6-point Likert-type response scale, ranging from 0 (none) to 5 (very severe). Total scores are in the range of 0-5, with higher scores reflecting greater symptom severity.	Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days)
GIQLI questionnaire	36-item questionnaire based on a 0-4 Likert-type scale, ranging from 0 (least desirable option) to 4 (most desirable option). Total scores range from 0 to 144, with higher scores indicating a better quality of life.	Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days)

Collaborators and Investigators

• Sponsor: Samita Garg
• Investigators: Principal Investigator: Samita Garg, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Gastroparesis; Continuous Glucose Monitor
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Endocrine System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Gastroparesis
• Other Study ID Numbers: 23-594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes