Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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 GCSI and GIQLI questionnaires will be performed to assess the association of gastroparesis symptoms with GM.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients with type 1 or type 2 diabetes and gastroparesis Both groups will have the same intervention. FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge. |
Device: FreeStyle Libre 3 continuous glucose monitoring sensor
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Other Names:
|
| Active Comparator: Patients with type 1 or type 2 diabetes without gastroparesis Both groups will have the same intervention. FreeStyle Libre 3 sensor for Continuous Glucose Monitoring. Balanced nutritional drink (Boost plus 8 ounces/237 mL) for a standardized meal challenge |
Device: FreeStyle Libre 3 continuous glucose monitoring sensor
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time-in-Range (TIR) [28 days of monitoring]
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-in-Tight Range (TITR) [28 days of monitoring]
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 Below Range (TBR) [28 days of monitoring]
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 Above Range (TAR) [28 days of monitoring]
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).
- Metrics of Glucose Variability [28 days of monitoring]
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)
Secondary Outcome Measures
- Hyperglycemia episodes [28 days of monitoring]
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)
- Hypoglycemia episodes [28 days of monitoring]
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)
Other Outcome Measures
- GCSI questionnaire [Visits 2 (Day 5 +/- 2 days) and 4 (Day 25 +/- 2 days)]
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.
- GIQLI questionnaire [Visits 2 (Day 5 +/- 2 days) and 4 (Day 25 +/- 2 days)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Over the age of 18 years.
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Hemoglobin A1c ≤11% within the last 6 months.
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Patients with diagnosis of type 1 Diabetes or type 2 Diabetes for at least one year.
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Normal TSH within the last year.
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No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 3 months requiring ER visit or hospitalization.
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Symptoms of gastroparesis have been present for at least the past 3 months, in patients with gastroparesis.
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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.
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Patients using a Smartphone (iPhone or Android) compatible with LibreView App.
Exclusion Criteria:
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Hemoglobin A1c of >11% at enrollment.
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Advanced chronic kidney disease (serum creatinine of >2 mg/dL or eGFR <30mL/min/1.73m² using CKD-EPI formula).
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Advanced and significant cardiovascular disease or unstable angina.
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Advanced liver disease that may affect glucose profiles.
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Post-transplant patients.
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History of gastric surgery.
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Presence of celiac disease.
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Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days.
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Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles.
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Patients on opiates or GLP-1 agonists (Ozempic, Wegovy, Mounjaro, Trulicity). If previously taking these medications, patients can be enrolled after 2 weeks of the last dose.
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Patient on recreational or illicit drugs (i.e., marijuana, opiates, cocaine, etc.).
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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.
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Clinically significant abnormalities on upper GI endoscopy.
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Presence of imaging evidence of gastric or intestinal obstruction.
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Patient previously participated in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Samita Garg
Investigators
- Principal Investigator: Samita Garg, MD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-594