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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
50
The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Cleveland Clinic Foundation
Cleveland, Ohio, United States
RECRUITINGTime-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 monitoring
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 monitoring
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 monitoring
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 monitoring
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)
Time frame: 28 days of monitoring
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 monitoring
Hypoglycemia episodes
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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 monitoring