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Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FreeStyle Libre 3 continuous glucose monitoring sensor
Nutritional drink
Sponsored by
Samita Garg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetes Mellitus, Type 2 focused on measuring Gastroparesis, Diabetes, Continuous Glucose Monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 3 months 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. Presence of celiac disease. 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.

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with type 1 or type 2 diabetes and gastroparesis

Patients with type 1 or type 2 diabetes without gastroparesis

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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-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 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 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).
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)

Secondary Outcome Measures

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)
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)

Full Information

First Posted
September 6, 2023
Last Updated
October 10, 2023
Sponsor
Samita Garg
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1. Study Identification

Unique Protocol Identification Number
NCT06046833
Brief Title
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samita Garg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Gastroparesis With Diabetes Mellitus
Keywords
Gastroparesis, Diabetes, Continuous Glucose Monitor

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Same intervention for two cohorts
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with type 1 or type 2 diabetes and gastroparesis
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with type 1 or type 2 diabetes without gastroparesis
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre 3 continuous glucose monitoring sensor
Other Intervention Name(s)
FreeStyle Libre 3 system
Intervention Description
The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute
Intervention Type
Other
Intervention Name(s)
Nutritional drink
Other Intervention Name(s)
Boost plus
Intervention Description
Balanced nutritional drink (Boost plus 8 ounces/237 mL)
Primary Outcome Measure Information:
Title
Time-in-Range (TIR)
Description
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
Title
Time-in-Tight Range (TITR)
Description
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
Title
Time Below Range (TBR)
Description
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
Title
Time Above Range (TAR)
Description
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
Title
Metrics of Glucose Variability
Description
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
Secondary Outcome Measure Information:
Title
Hyperglycemia episodes
Description
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
Title
Hypoglycemia episodes
Description
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
Other Pre-specified Outcome Measures:
Title
GCSI questionnaire
Description
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
Visits 2 (Day 5 +/- 2 days) and 4 (Day 25 +/- 2 days)
Title
GIQLI questionnaire
Description
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
Visits 2 (Day 5 +/- 2 days) and 4 (Day 25 +/- 2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 3 months 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. Presence of celiac disease. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samita Garg, MD
Phone
216-444-2384
Email
gargs@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Araujo-Duran, MD
Phone
216-444-7935
Email
araujoj@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samita Garg, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samita Garg, MD
Phone
216-444-2384
Email
gargs@ccf.org
First Name & Middle Initial & Last Name & Degree
Jorge Araujo-Duran, MD
Phone
216-444-7935
Email
araujoj@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes

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