Trial | NCT03313960  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    400
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.
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).
Study Started
Oct 05
2017
Primary Completion
Sep 30
2018
Study Completion
Dec 30
2019
Anticipated
Last Update
Feb 26
2019

Drug Afrezza plus One Drop | Premium

Participants in this group will receive insulin inhalation, prescribed by their physician, and will also receive One Drop | Premium (i.e., One Drop | Experts in-app coaching from a Certified Diabetes Educator (CDE) along with One Drop | Chrome Bluetooth-connected blood glucose meter that uploads results into the One Drop | Mobile app and 150 test strips per month for three months).

  • Other names: insulin inhalation

Other One Drop | Premium

Participants in this group will receive One Drop | Premium (i.e., One Drop | Experts in-app CDE coaching with the One Drop | Chrome Bluetooth-connected blood glucose meter that uploads results into the One Drop | Mobile app and 150 test strips per month for three months).

One Drop | Premium with Afrezza Active Comparator

One Drop | Premium without Afrezza Other

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
No Results Posted