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
Samita Garg
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 scinti…
Interventions
- DeviceFreeStyle 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
- OtherNutritional drink
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Location
- Cleveland Clinic FoundationCleveland, Ohio