Pre-DiabetesPREDICT-DMNCT03544320
Prediction Using Connected Technologies for Diabetes
A study testing Activity Monitoring-Wrist worn wearable and Activity Monitoring-Waist-worn wearable in people with Pre-Diabetes, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-Diabetes
- What is being tested?
- Activity Monitoring-Wrist worn wearable and Activity Monitoring-Waist-worn wearable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years or older
- Be able to provide informed consent
- Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months
- Baseline hemoglobin A1c of 5.7 to 6.4
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Activity Monitoring-Wrist worn wearable, Activity Monitoring-Waist-worn wearable
- Keywords
- Pre-diabetes, diabetes, wearable devices, mobile health
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Monitoring-Wrist worn wearableDevice
Participants wear an activity monitor on their wrist.
Activity Monitoring-Waist-worn wearableDevice
Participants wear an activity monitor on their waist.
| Study group | Role | What they receive |
|---|---|---|
| Activity Monitoring-Wrist worn wearable | Active comparator | 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. Receives: Device: Activity Monitoring-Wrist worn wearable |
| Activity Monitoring-Waist-worn wearable | Active comparator | Participants in the activity monitoring-waist worn wearable group will be randomly assigned to track their activity using a Fitbit Zip for 6 months. Receives: Device: Activity Monitoring-Waist-worn wearable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin A1c
Change in hemoglobin A1c from baseline to 6 months
Measured: 6 months
Secondary outcomes (1)
Change in low-density lipoprotein (LDL) levels
Change in LDL level from baseline to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start9 Jul 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitesh S Patel, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544320
- Sponsor's protocol ID
- 829150
- Acronym
- PREDICT-DM
- Status last verified
- Aug 2019
- First submitted
- 18 May 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Using a Randomized Evaluation of Data Collection Integrated Through Connected Technologies for Diabetes Management
- ClinicalTrials.gov ID
- NCT03544320
- Acronym / sponsor ID
- PREDICT-DM / 829150
- Conditions
- Pre-Diabetes
- Keywords
- Pre-diabetes, diabetes, wearable devices, mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Activity Monitoring-Wrist worn wearable | Active comparator | Device: Activity Monitoring-Wrist worn wearableParticipants in the activity monitoring-wrist worn wearable group will be randomly assigned to track their activity using a Fitbit Charge 2 for 6 months. |
| Activity Monitoring-Waist-worn wearable | Active comparator | Device: Activity Monitoring-Waist-worn wearableParticipants in the activity monitoring-waist worn wearable group will be randomly assigned to track their activity using a Fitbit Zip for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years or older
- Be able to provide informed consent
- Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months
- Baseline hemoglobin A1c of 5.7 to 6.4
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity Monitoring-Wrist worn wearableParticipants wear an activity monitor on their wrist. | Device | Activity Monitoring-Wrist worn wearable |
| Activity Monitoring-Waist-worn wearableParticipants wear an activity monitor on their waist. | Device | Activity Monitoring-Waist-worn wearable |
Primary outcome
Change in hemoglobin A1c
Time frame: 6 months
Change in hemoglobin A1c from baseline to 6 months
1 secondary outcome
Change in low-density lipoprotein (LDL) levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitesh S Patel, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Monitoring-Wrist worn wearable and Activity Monitoring-Waist-worn wearable in people with Pre-Diabetes, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin A1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.