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

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Informed Data Systems, Inc.
• Collaborator: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

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