A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone

Status unconfirmed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03313960

Run by

Informed Data Systems, Inc.

People needed

400

Starts

2017-10-05

Expected to finish

2019-12-30

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• One Drop — New York, New York, United States

Full record on ClinicalTrials.gov

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