Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
ID: NCT06046833
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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.
Read Full Scientific Objectives & Methods
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.
The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Treatment Arms 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.
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
- 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.
- 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.
Primary Outcome Measures
- Time-in-Range (TIR) — Time Frame: 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-in-Tight Range (TITR) — Time Frame: 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 Below Range (TBR) — Time Frame: 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 Above Range (TAR) — Time Frame: 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).
- Metrics of Glucose Variability — Time Frame: 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)
View Secondary Outcome Measures (2)
- Hyperglycemia episodes — Time Frame: 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 — Time Frame: 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)
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
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View Official Medical/Scientific Title
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