Prediction Using Connected Technologies for Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prediction Using a Randomized Evaluation of Data Collection Integrated Through Connected Technologies for Diabetes Management

Conditions
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Pre-Diabetes

Intervention / Treatment
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* Device: Activity Monitoring-Wrist worn wearable
* Device: Activity Monitoring-Waist-worn wearable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years or older Be able to provide informed consent Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Activity Monitoring-Wrist worn wearable<br>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. | Device: Activity Monitoring-Wrist worn wearable<br>* Participants wear an activity monitor on their wrist.<br>|
| Active Comparator: Activity Monitoring-Waist-worn wearable<br>Participants in the activity monitoring-waist worn wearable group will be randomly assigned to track their activity using a Fitbit Zip for 6 months. | Device: Activity Monitoring-Waist-worn wearable<br>* Participants wear an activity monitor on their waist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c | Change in hemoglobin A1c from baseline to 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in low-density lipoprotein (LDL) levels | Change in LDL level from baseline to 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-diabetes, diabetes, wearable devices, mobile health