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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2024
Source The Cleveland Clinic
Contact Samita Garg, MD
Phone 216-444-2384
Email gargs@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Samita Garg

Country where clinical trial is conducted

United States, 

Outcome

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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