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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
100
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).
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.
Clinical Research Department
Midland, Michigan, United States
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.
Time frame: Day 0 - Day 120
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
Time frame: Day 0 - Day 120
Mean Duration of Time to Reach Optimal Insulin Glargine Dose
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Day 0 - Day 120
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