Prediction Using Connected Technologies for Diabetes (PREDICT-DM)

University of Pennsylvania

Status: Completed

Conditions: Pre-Diabetes

Treatments: Device: Activity Monitoring-Wrist worn wearable; Device: Activity Monitoring-Waist-worn wearable

Study type: Interventional

Funder types: Other

Identifiers

NCT03544320

829150

Details and patient eligibility

About

In this study, adults with pre-diabetes will be prospectively enrolled for data collection to design prediction models that integrate electronic health record data and patient-generated activity data. Patients will be randomized to receive either a waist-worn or wrist-worn wearable device for 6 months to capture patient-generated activity data.

Full description

Patients with suboptimal glycemic control could be better managed if these higher risk patients could be identified and effective interventions were then targeted towards them. However, most practice settings perform infrequent laboratory testing every 3 to 6 months, if not at longer intervals. Current models to predict change in glycemic control perform poorly and do not take into account the behaviors that occur between these intervals. In this study, we will compare different methods to use data on daily health behaviors collected by wearable devices to enhance risk prediction models. Adults with pre-diabetes will complete a series of surveys and baseline assessments and then will be randomly assigned to use a waist-worn or wrist-worn wearable device for 6 months. Measures of HbA1c and LDL will be obtained at baseline and at 6 months.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be 18 years or older
2. Be able to provide informed consent
3. Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months
4. Baseline hemoglobin A1c of 5.7 to 6.4

Exclusion criteria

Participants will no be eligible if they have any medical condition or other reason that will likely prohibit them from completing the 6-month study

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 2 patient groups

Activity Monitoring-Wrist worn wearable

Active Comparator group

Description:

Participants in the activity monitoring-wrist worn wearable group will be randomly assigned to track their activity using a Fitbit Charge 2 for 6 months.

Treatment:

Device: Activity Monitoring-Wrist worn wearable

Activity Monitoring-Waist-worn wearable

Active Comparator group

Description:

Participants in the activity monitoring-waist worn wearable group will be randomly assigned to track their activity using a Fitbit Zip for 6 months.

Treatment:

Device: Activity Monitoring-Waist-worn wearable