A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
Status: | Active, not recruiting |
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Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 2/28/2019 |
Start Date: | October 5, 2017 |
End Date: | December 30, 2019 |
A-One: A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
The A-One study is a prospective, randomized controlled trial evaluating the use of the One
Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control,
treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of
people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) > 7.0% already prescribed an
injectable rapid-acting insulin.
Drop | Premium 'On Track' in combination with Afrezza treatment on the glycemic control,
treatment adherence, social-cognitive barriers to adherence, and treatment satisfaction of
people with Type 2 diabetes (T2D) and a hemoglobin A1c (A1c) > 7.0% already prescribed an
injectable rapid-acting insulin.
Eligible participants (N=400) with an A1c > 7.0% already prescribed a rapid-acting insulin
will be randomized to one of two groups: (1) One Drop | Premium 'On Track' (i.e., use the One
Drop | Mobile app with in-app diabetes education accredited by the American Diabetes
Association with supplemental Afrezza content and a live Certified Diabetes Educator
messaging in the app, the 'Chrome' Bluetooth-connected blood glucose meter that uploads blood
glucose values in the app, and 150 test strips per month) in combination with Afrezza
treatment (n=200) or (2) One Drop | Premium 'On Track' plus their current rapid-acting
insulin (n=200).
will be randomized to one of two groups: (1) One Drop | Premium 'On Track' (i.e., use the One
Drop | Mobile app with in-app diabetes education accredited by the American Diabetes
Association with supplemental Afrezza content and a live Certified Diabetes Educator
messaging in the app, the 'Chrome' Bluetooth-connected blood glucose meter that uploads blood
glucose values in the app, and 150 test strips per month) in combination with Afrezza
treatment (n=200) or (2) One Drop | Premium 'On Track' plus their current rapid-acting
insulin (n=200).
Inclusion Criteria:
- 18-75 years of age
- Self-reported diagnosis of T2D
- Diagnosed with diabetes for at least 12 months
- Prescribed a prandial rapid-acting insulin
- Willing to take Afrezza rapid-acting insulin for 3 months instead of current
rapid-acting insulin
- Willing to get a physician's prescription for Afrezza
- Self-reported A1c > 7.0% (later confirmed with a mail-in A1c laboratory test)
- Owns and uses an iPhone or Android phone with an operating system compatible with the
One Drop | Mobile app
- Has successfully downloaded and used a smart phone application previously
Exclusion Criteria:
- Currently pregnant or planning to become pregnant during the trial period
- Cannot read or write in English
- Currently in a diabetes education or coaching program
- Had previously used One Drop | Premium or One Drop |
- Experts coaching
- Had previously used or is currently using Afrezza
- Currently smokes (cigaretts, e-cigs, pipes, cigars, marijuana) or has smoked anytime
in the past 6 months
- Has chronic lung disease, e.g., COPD and asthma
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