Prediction Using Connected Technologies for Diabetes

Pre-Diabetes Clinical Trial

— PREDICT-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544320
• Other study ID #: 829150
• Status: Completed
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre-Diabetes
• Prediabetic State

Intervention

Device:
• Activity Monitoring-Wrist worn wearable
Participants wear an activity monitor on their wrist.
• Activity Monitoring-Waist-worn wearable
Participants wear an activity monitor on their waist.

Locations

Country	Name	City	State
United States	Penn Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization	Admission to the hospital	6 months
Primary	Change in hemoglobin A1c	Change in hemoglobin A1c from baseline to 6 months	6 months
Secondary	Change in low-density lipoprotein (LDL) levels	Change in LDL level from baseline to 6 months	6 months