Status:
UNKNOWN
A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
Lead Sponsor:
Informed Data Systems, Inc.
Collaborating Sponsors:
Mannkind Corporation
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 adherenc...
Detailed Description
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 \| Mobil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03313960
Start Date
October 5 2017
End Date
December 30 2019
Last Update
February 26 2019
Active Locations (1)
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1
One Drop
New York, New York, United States, 10002