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| ID | Type | Description | Link |
|---|---|---|---|
| ADA Grant #7-25-ICTSPC-412 | Other Grant/Funding Number | American Diabetes Association |
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Prediabetes affects over one-third of adults in the United States, placing them at a higher risk for developing type 2 diabetes and heart disease, which can lead to serious health complications and increased medical costs. Although a program called the Diabetes Prevention Program (DPP) has been shown to lower the risk of diabetes through healthy lifestyle changes, many people find it difficult to stick with these changes over the long term. This study seeks to find out if combining DPP coaching with continuous glucose monitoring (CGM) technology can help people stay on track with their health goals.
CGM devices give individuals real-time information about their blood sugar levels, which can help them understand how their diet, exercise, and daily habits impact their health. By pairing CGM technology with support from trained DPP coaches, this approach aims to make it easier for participants to maintain healthy behaviors. The study will involve 214 adults with prediabetes who will follow a 12-month program with regular check-ins to measure improvements in blood sugar control, weight loss, physical activity, and overall quality of life.
The goal is to show whether using CGM in combination with coaching can lead to better health outcomes and whether it is a cost-effective way to prevent diabetes. If successful, this approach could be used in healthcare settings across the country, helping more people prevent diabetes and lead healthier lives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Diabetes Prevention Program |
|
| Intervention | Experimental | Diabetes Prevention Program + Continuous Glucose Monitors/Coaching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM-DPP | Behavioral | Participants in the DPP who receive personalized CGM coaching. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control (HbA1c) | Blood specimens (10 cc of blood) will be obtain by trained phlebotomists or nurse for HbA1c. | Change from baseline HbA1c at 12 months post intervention follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as measured by SF-12 | The SF-12 (Ware 1996) is a valid and reliable instrument to measure functional status and reproduces 90% of the variance in PCS-36 and MCS-36 scores. | Change from baseline quality of life measure at 12 months post intervention follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Care | Behavioral skills will be assessed with the Summary of Diabetes Self-Care Activities (SDSCA) scale (Toobert 2000), a brief, validated questionnaire of diabetes self-care. | Change from baseline self-care at 12 months post intervention follow-ups |
Inclusion Criteria:
Exclusion Criteria:
Individuals will be excluded from the study if they
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphael A Fraser, PhD, MS | Contact | 7168295733 | rfraser@buffalo.edu | |
| Jocelyn Stooks, MPH | Contact | 7168292364 | jstooks@buffalo.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Population Health, Department of Medicine | Recruiting | Buffalo | New York | 14203 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Control |
| Behavioral |
Participants in control group will be referred to DPP. |
|
| D004700 | Endocrine System Diseases |