Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with type 1 or type 2 diabetes and gastroparesis | Experimental | Both groups will have the same intervention.
|
|
| Patients with type 1 or type 2 diabetes without gastroparesis | Active Comparator | Both groups will have the same intervention.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre 3 continuous glucose monitoring sensor | Device | The Freestyle Libre 3 sensor is a small real-time continuous glucose monitor device that measures glucose levels every minute |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Metrics of Glucose Variability |
| 28 days of monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hypoglycemia episodes |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| GIQLI questionnaire |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samita Garg, MD | Contact | 216-444-2384 | gargs@ccf.org | |
| Jorge Araujo-Duran, MD | Contact | 216-444-7935 | araujoj@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Samita Garg, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| D018589 | Gastroparesis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Same intervention for two cohorts
Not provided
Not provided
Not provided
Not provided
|
| Nutritional drink | Other | Balanced nutritional drink (Boost plus 8 ounces/237 mL) |
|
|
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 |
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) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |