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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study compares blood sugar patterns in adults with type 1 or type 2 diabetes, with or without gastroparesis. Gastroparesis means the stomach empties too slowly. The study uses a FreeStyle Libre 3 sensor to track blood sugar in real time.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You have had type 1 or type 2 diabetes for at least 1 year.
  • Your A1c, a measure of average blood sugar, was 11% or less within the past 6 months.
  • Your thyroid-stimulating hormone (TSH) test was normal within the past year.
  • In the past 2 weeks, you have not needed an ER visit or hospital stay for low blood sugar or the serious diabetes emergencies called DKA or HHS.
  • If you have gastroparesis, you have had symptoms for at least 3 months.
  • If you have gastroparesis, a stomach scan or Smart Pill test in the past 5 years showed slow emptying: more than 10% stayed in the stomach after 4 hours, or passage through the stomach took more than 4 hours.
  • You use an iPhone or Android phone that works with the LibreView app.

Who can't join

  • Your A1c is above 11% when you enroll, or you have advanced kidney disease: creatinine above 2 mg/dL or eGFR below 30, which are measures of kidney function.
  • You have serious, advanced heart or blood vessel disease, unstable chest pain called angina, or advanced liver disease that may affect blood sugar.
  • You have had an organ transplant or stomach surgery, or you have already taken part in this study.
  • You have celiac disease symptoms at enrollment, major problems found during an upper digestive tract scope exam, or a scan showing a blocked stomach or intestine.
  • You are pregnant, or you can become pregnant and have not used adequate pregnancy precautions for 28 days.
  • You take steroids, medicines that change the immune system, or cancer treatment with chemotherapy and radiation that may affect blood sugar; or you use recreational or illegal drugs, such as marijuana, opiates, or cocaine.
  • You take opiate medicines or GLP-1 medicines such as Ozempic, Wegovy, Mounjaro, or Trulicity. If you previously took them, you may enroll 2 weeks after the last dose.
  • You take medicines that help move food through the gut: Reglan (metoclopramide), Motegrity (prucalopride), cisapride, domperidone, or erythromycin. If you previously took them, you may enroll 1 week after the last dose.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

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