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| Name | Class |
|---|---|
| SHL Medical | UNKNOWN |
| MidMichigan Health | UNKNOWN |
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This single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the Chronicare Disease Management Program in the management of subjects with T2D who are being treated with insulin glargine and metformin. The Chronicare Solution comprises connected devices (a Bluetooth-enabled insulin pen sensor, a Bluetooth-enabled medication container, and a Bluetooth-enabled glucometer), a mobile smartphone app (CRx Health), an automated support system (Intervention Engine), and a remote care application (CRx Care) used by a team of clinicians to monitor and support patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Subjects in the Intervention arm will receive the following:
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| Control | Active Comparator | Subjects in the Control arm will receive the CRx Health solution for self-management of chronic conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRx Health | Other | CRx Health is a connected health solution comprised of connected devices (InsulCheck, a Bluetooth-enabled pill bottle cap, and a Bluetooth-enabled glucometer) paired to a mobile smartphone app (CRx Health). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | The primary endpoint is the difference in the reduction in HbA1c for each subject by treatment group (Intervention vs. Control), assessed by the mean reduction across all subjects in each treatment group. | Day 0 - Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Glucose | Fasting blood glucose level (Intervention vs. Control), measured by the proportion of measurements of self-reported fasting blood glucose within the range of 70-110 mg/dL for subjects in each study arm | Day 0 - Day 120 |
| Mean Duration of Time to Reach Optimal Insulin Glargine Dose |
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Inclusion Criteria:
Exclusion Criteria:
mifepristone, GLP-1RA, or any insulin other than insulin glargine.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brenda Whitman, RN | Contact | (989) 839-3018 | cvresearch@midmichigan.org |
| Name | Affiliation | Role |
|---|---|---|
| Sujay Madduri, MD | MidMichigan Health | Principal Investigator |
| Alexander Dahmani | QuiO Technologies | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Department | Midland | Michigan | 48670 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Chronicare | Other | Chronicare is a disease management program comprising self-management data from the CRx Health solution syncing to an automated support system (Intervention Engine) and a remote care application (CRx Care) used by a team of clinicians to remotely monitor and support patients. |
|
Optimal insulin glargine dose (Intervention vs. Control), measured by the mean duration of time elapsed prior to reaching a mean self-reported fasting blood glucose value of 70-110 mg/dL over a 7-day period. |
| Up to 120 days |
| Proportion of Patients Reaching Optimal Insulin Glargine Dose | Optimal insulin glargine dose (Intervention vs. Control), measured by the proportion of patients reaching a mean self-reported fasting blood glucose value of 70-110 mg/dL over a 7-day period. | Day 120 |
| Median Adherence to Insulin Glargine | Insulin glargine adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window). | Day 0 - Day 120 |
| Median Adherence to Metformin | Metformin adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window). | Day 0 - Day 120 |
| D004700 | Endocrine System Diseases |