Prediction Using Connected Technologies for Diabetes

Not Applicable

Completed

• Conditions: Pre-Diabetes
• Interventions: Device: Activity Monitoring-Waist-worn wearable; Device: Activity Monitoring-Wrist worn wearable

• Registration Number: NCT03544320
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-06-01
• Study Start: 2018-07-09
• Status Verified: 2019-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity Monitoring-Waist-worn wearable	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.
Activity Monitoring-Wrist worn wearable	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.

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c	6 months	Change in hemoglobin A1c from baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Change in low-density lipoprotein (LDL) levels	6 months	Change in LDL level from baseline to 6 months

Trial Locations

Locations (1)

Penn Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States