Diabetes Mellitus, Type 2 Clinical Trial
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
NCT number | NCT06046833 |
Other study ID # | 23-594 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 8, 2024 |
Est. completion date | September 2024 |
Verified date | April 2024 |
Source | The Cleveland Clinic |
Contact | Samita Garg, MD |
Phone | 216-444-2384 |
gargs[@]ccf.org | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Samita Garg |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | GCSI questionnaire | 9 symptoms item questionnaire with a 6-point Likert-type response scale, ranging from 0 (none) to 5 (very severe). Total scores are in the range of 0-5, with higher scores reflecting greater symptom severity. | Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days) | |
Other | GIQLI questionnaire | 36-item questionnaire based on a 0-4 Likert-type scale, ranging from 0 (least desirable option) to 4 (most desirable option). Total scores range from 0 to 144, with higher scores indicating a better quality of life. | Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days) | |
Primary | Time-in-Range (TIR) | 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. | 28 days of monitoring | |
Primary | Time-in-Tight Range (TITR) | 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. | 28 days of monitoring | |
Primary | Time Below Range (TBR) | 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) | 28 days of monitoring | |
Primary | Time Above Range (TAR) | 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). | 28 days of monitoring | |
Primary | Metrics of Glucose Variability | 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) |
28 days of monitoring | |
Secondary | Hyperglycemia episodes | 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) | 28 days of monitoring | |
Secondary | Hypoglycemia episodes | 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) | 28 days of monitoring |
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