NCT03544320

Prediction Using Connected Technologies for Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-Diabetes

Interventions

Type	Name	Description
DEVICE	Activity Monitoring-Wrist worn wearable	Participants wear an activity monitor on their wrist.
DEVICE	Activity Monitoring-Waist-worn wearable	Participants wear an activity monitor on their waist.

Timeline

• Start date: 2018-07-09
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2018-06-01
• Last updated: 2019-08-29

Locations

1 site across 1 country: United States