Prediction Using Connected Technologies for Diabetes (PREDICT-DM)

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-Diabetes
• Intervention / Treatment: Device: Activity Monitoring-Wrist worn wearable; Device: Activity Monitoring-Waist-worn wearable

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 Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Activity Monitoring-Wrist worn wearable; Participants wear an activity monitor on their wrist.
Active Comparator: 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.	Device: Activity Monitoring-Waist-worn wearable; Participants wear an activity monitor on their waist.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Admission to the hospital	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Mitesh S Patel, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: diabetes; mobile health; Pre-diabetes; wearable devices
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 829150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No