Prediction Using Connected Technologies for Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-09

Study Completion Date

2019-08-01

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.

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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.

Conditions

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Pre-Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The participants will be aware of the two different study arms and the wearable devices used in both. The study investigator will not have not have knowledge of the participants assigned to each arm.

Study Groups

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Activity Monitoring-Wrist worn wearable

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.

Group Type ACTIVE_COMPARATOR

Activity Monitoring-Wrist worn wearable

Intervention Type DEVICE

Participants wear an activity monitor on their wrist.

Activity Monitoring-Waist-worn wearable

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

Group Type ACTIVE_COMPARATOR

Activity Monitoring-Waist-worn wearable

Intervention Type DEVICE

Participants wear an activity monitor on their waist.

Interventions

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Activity Monitoring-Wrist worn wearable

Participants wear an activity monitor on their wrist.

Intervention Type DEVICE

Activity Monitoring-Waist-worn wearable

Participants wear an activity monitor on their waist.

Intervention Type DEVICE

Eligibility Criteria

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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