Type 2 Diabetes Mellitus Clinical Trial
Official title:
One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
| NCT number | NCT02827669 |
| Other study ID # | EH-001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2016 |
| Est. completion date | February 2017 |
| Verified date | December 2019 |
| Source | Evidation Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 297 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Evidation Health | San Mateo | California |
| Lead Sponsor | Collaborator |
|---|---|
| Evidation Health | One Drop |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | 3 months |
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