Type 2 Diabetes MellitusNCT02827669
One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
A study testing One Drop Experts Program and One Drop Experts Program + Apple Watch in people with Type 2 Diabetes Mellitus, run by Evidation Health at 1 site in United States.
Trial summary
The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- One Drop Experts Program and One Drop Experts Program + Apple Watch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Feb 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported Type 2 diabetes diagnosis
- Has not changed treatment regimen in the last 3 months
- HbA1c levels ≥ 7.5% by self-report and verified by lab test
- Motivated to use a daily diabetes self-management coaching program to improve diabetes control
- Owns and uses an iPhone with a compatible iOS operating system and has successfully downloaded and used a smartphone application previously
Who cannot join
- Current use of a smartphone application to manage their diabetes
- Currently participating in a diabetes self-management education or coaching program
- Currently pregnant
- Does not understand English
- History of serious mental illness or dementia
- Has severe diabetic complications such as severe diabetic retinopathy, chronic kidney disease (stages 4-5), severe diabetic neuropathy, diabetic foot ulcer or infection
Trial locations and contacts
1 site in 1 country.
About this study
The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2 diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch in combination with the One Drop app and Experts program, and assess whether this group is more engaged or experiences a different impact as compared to participants who utilized the One Drop app and Experts program only.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- One Drop Experts Program, One Drop Experts Program + Apple Watch
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Drop Experts ProgramBehavioural
One Drop Experts Program + Apple WatchBehavioural
| Study group | Role | What they receive |
|---|---|---|
| One Drop Experts Program | Experimental | Participants will be able to use the One Drop mobile app and One Drop Experts program on their smartphones. The One Drop mobile app is a diabetes management platform that allows users to track and log their blood glucose levels, medications, food, and activities. One Drop Experts is a diabetes education and coaching program delivered entirely through the One Drop mobile application. Receives: Behavioral: One Drop Experts Program |
| One Drop Experts Program + Apple Watch | Experimental | An Apple Watch will be provided to study participants in this arm. In addition to using the One Drop mobile app and One Drop Experts program on their smartphones, participants will also be able to engage with the app and program on their Apple Watch. Receives: Behavioral: One Drop Experts Program + Apple Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evidation Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- One Drop
- Responsible party
- Principal investigator, Jessie Juusola, Evidation Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827669
- Sponsor's protocol ID
- EH-001
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
- ClinicalTrials.gov ID
- NCT02827669
- Acronym / sponsor ID
- EH-001
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Evidation HealthIndustry (pharma, biotech, devices)
- Collaborators
- One Drop
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2 diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch in combination with the One Drop app and Experts program, and assess whether this group is more engaged or experiences a different impact as compared to participants who utilized the One Drop app and Experts program only.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One Drop Experts Program | Experimental | Behavioral: One Drop Experts ProgramParticipants will be able to use the One Drop mobile app and One Drop Experts program on their smartphones. The One Drop mobile app is a diabetes management platform that allows users to track and log their blood glucose levels, medications, food, and activities. One Drop Experts is a diabetes education and coaching program delivered entirely through the One Drop mobile application. |
| One Drop Experts Program + Apple Watch | Experimental | Behavioral: One Drop Experts Program + Apple WatchAn Apple Watch will be provided to study participants in this arm. In addition to using the One Drop mobile app and One Drop Experts program on their smartphones, participants will also be able to engage with the app and program on their Apple Watch. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported Type 2 diabetes diagnosis
- Has not changed treatment regimen in the last 3 months
- HbA1c levels ≥ 7.5% by self-report and verified by lab test
- Motivated to use a daily diabetes self-management coaching program to improve diabetes control
- Owns and uses an iPhone with a compatible iOS operating system and has successfully downloaded and used a smartphone application previously
Key exclusion criteria (6 listed)
- Current use of a smartphone application to manage their diabetes
- Currently participating in a diabetes self-management education or coaching program
- Currently pregnant
- Does not understand English
- History of serious mental illness or dementia
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 |
|---|---|---|
| One Drop Experts Program | Behavioural | One Drop Experts Program |
| One Drop Experts Program + Apple Watch | Behavioural | One Drop Experts Program + Apple Watch |
Primary outcome
HbA1c
Time frame: 3 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 12 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Drop Experts Program and One Drop Experts Program + Apple Watch in people with Type 2 Diabetes Mellitus, run by Evidation Health 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 5 inclusion and 6 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 12 Dec 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?
HbA1c (time frame: 3 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 12 Dec 2019.