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

Samita Garg

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1; Gastroparesis With Diabetes Mellitus; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06046833

23-594

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Patients with type 1 or type 2 diabetes and gastroparesis

Experimental group

Description:

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.

Treatment:

Other: Nutritional drink

Device: FreeStyle Libre 3 continuous glucose monitoring sensor

Patients with type 1 or type 2 diabetes without gastroparesis

Active Comparator group

Description:

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

Treatment:

Other: Nutritional drink

Device: FreeStyle Libre 3 continuous glucose monitoring sensor