Pre-Diabetes
Conditions
Keywords
Pre-diabetes, diabetes, wearable devices, mobile health
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.
Interventions
DEVICEActivity Monitoring-Wrist worn wearable
Participants wear an activity monitor on their wrist.
DEVICEActivity Monitoring-Waist-worn wearable
Participants wear an activity monitor on their waist.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin A1c | 6 months | Change in hemoglobin A1c from baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in low-density lipoprotein (LDL) levels | 6 months | Change in LDL level from baseline to 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | 6 months | Admission to the hospital |
Countries
United States
Outcome results
None listed