Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FreeStyle Libre 3 continuous glucose monitoring sensor, Nutritional drink.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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.
Interventions
- 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 Nutritional drink
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Primary outcome measures
- Time-in-Range (TIR) [Time frame: 28 days of monitoring]
- Time-in-Tight Range (TITR) [Time frame: 28 days of monitoring]
- Time Below Range (TBR) [Time frame: 28 days of monitoring]
- Time Above Range (TAR) [Time frame: 28 days of monitoring]
- Metrics of Glucose Variability [Time frame: 28 days of monitoring]
Secondary outcome measures (2)
- Hyperglycemia episodes [Time frame: 28 days of monitoring]
- Hypoglycemia episodes [Time frame: 28 days of monitoring]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Cleveland Clinic Foundation — Cleveland
Identifiers
NCT: NCT06046833 · 23-594