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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Afrezza plus One Drop | Premium
* Other: One Drop | Premium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One Drop | Premium with Afrezza<br> | Drug: Afrezza plus One Drop | Premium<br>* 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).<br>* Other names: insulin inhalation;|
| Other: One Drop | Premium without Afrezza<br> | Other: One Drop | Premium<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | 3-month between-group change in A1c assessed by a central lab | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Device Satisfaction | Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS) | 3 months | 
| Treatment Adherence | Within- and between-group change in treatment adherence assessed by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D) and the Summary of Diabetes Self-care Activities Medications Subscale administered for each oral diabetes medication (SDSCA-MS) and insulin in the regimen (SDSCA-IS). | 3 months | 
| Self-care | Within- and between-group change in self-care assessed by the SDSCA's other subscales | 3 months | 
| Health-related Productivity | Within- and between-group change in health-related productivity assessed by the Work Productivity and Activity Impairment measure (WPAI). | 3 months | 
| Health-related Quality of Life | Within- and between-group change in health-related quality of life assessed by the Centers for Disease Control Health-related Quality of Life-14 (CDC HRQOL-14) and life satisfaction assessed by the Cantril Self-Anchoring Ladder of Life Satisfaction. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Afrezza