Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSamita Garg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FreeStyle Libre 3 continuous glucose monitoring sensor
DeviceThe Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute
Nutritional drink
Other interventionBalanced nutritional drink (Boost plus 8 ounces/237 mL)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Patients with type 1 or type 2 diabetes and gastroparesisExperimental treatment 2 interventions
Group B: Patients with type 1 or type 2 diabetes without gastroparesisActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
28 days of monitoring2
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.
Time frame
28 days of monitoring3
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)
Time frame
28 days of monitoring4
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).
Time frame
28 days of monitoringSecondary outcomes
1
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)
Time frame
28 days of monitoring2
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)
Time frame
28 days of monitoringOther outcomes
1
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.
Time frame
Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days)2
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.
Time frame
Visit 2 - Day 5 (-3/+6 days), and Visit 4 - Day 25 (-7/+3 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Samita Garg
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov