Actively Recruiting
Glucose Metrics Using FreeStyle Libre 3 Continuous Glucose Monitor in Patients With Gastroparesis in Type 1 or Type 2 Diabetes: Investigator Initiated Pilot Study
Led by Samita Garg · Updated on 2025-04-25
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating glucose metrics using a real-time continuous glucose monitor, the FreeStyle Libre 3 sensor, in patients with type 1 or type 2 diabetes who either have gastroparesis or do not. The study aims to compare glucose levels and variability between these two groups over 28 days and during two standardized meal challenge visits. This pilot study also seeks to develop a new tool called the Diabetic Gastroparesis Index to help identify early gastroparesis in diabetic patients using glucose data, potentially aiding early diagnosis and treatment decisions. Participants in both groups will use the FreeStyle Libre 3 sensor to continuously monitor glucose levels every minute. They will also consume a balanced nutritional drink (Boost plus 8 ounces/237 mL) during standardized meal challenges to assess glucose response. The study lasts 28 days, during which glucose metrics such as time in range, time above or below range, and glucose variability will be recorded. Both groups undergo the same procedures to ensure consistent data collection. Throughout the study, participants will be monitored for episodes of high and low blood sugar. They will complete questionnaires assessing gastroparesis symptoms and gastrointestinal quality of life to explore links with glucose metrics. Data on glucose control and symptom severity will be collected and analyzed. The study actively tracks glucose patterns and symptoms over the 28-day period to better understand the relationship between gastroparesis and glucose control in diabetes.
CONDITIONS
Brief Title
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over the age of 18 years
- Hemoglobin A1c 11% within the last 6 months
- Diagnosis of type 1 or type 2 diabetes for at least one year
- Normal thyroid-stimulating hormone (TSH) within the last year
- No recent episodes (past 2 weeks) of diabetic ketoacidosis, hyperosmolar hyperglycemic status, or severe hypoglycemia requiring emergency care
- For gastroparesis patients: symptoms present for at least 3 months
- For gastroparesis patients: documented delayed gastric emptying by scintigraphy or wireless motility capsule in past five years
- Use of a smartphone compatible with LibreView App (iPhone or Android)
You will not qualify if you...
- Hemoglobin A1c greater than 11% at enrollment
- Advanced chronic kidney disease with creatinine >2 mg/dL or eGFR <30 mL/min/1.73m8
- Advanced cardiovascular disease or unstable angina
- Advanced liver disease affecting glucose profiles
- History of gastric surgery
- Post-transplant patients
- Symptoms due to celiac disease at enrollment
- Pregnancy or women of reproductive age not using adequate pregnancy precautions
- Use of steroids, immunomodulators, or chemoradiation affecting glucose
- Use of opiates or GLP-1 agonists without a 2-week washout
- Use of motility medications without a 1-week washout
- Use of recreational or illicit drugs
- Clinically significant abnormalities on upper GI endoscopy
- Imaging evidence of gastric or intestinal obstruction
- Previous participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants wear a FreeStyle Libre 3 continuous glucose monitoring sensor to measure glucose levels continuously over 28 days, including during two standardized meal challenge visits using a balanced nutritional drink.
Continuous monitoring with 2 in-person meal challenge visits
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Samita Garg, MD
J
Jorge Araujo-Duran, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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