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

Informed Data Systems, Inc.400 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Diabetes Mellitus, Type 2

Interventions

Afrezza plus One Drop | PremiumDRUG

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).

One Drop | PremiumOTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

One Drop

New York, New York, United States

Outcomes

Primary Outcomes

Hemoglobin A1c

3-month between-group change in A1c assessed by a central lab

Time frame: 3 months

Secondary Outcomes

Insulin Device Satisfaction

Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS)

Time frame: 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).

Time frame: 3 months

Self-care

Within- and between-group change in self-care assessed by the SDSCA's other subscales

Time frame: 3 months

Health-related Productivity

Within- and between-group change in health-related productivity assessed by the Work Productivity and Activity Impairment measure (WPAI).

Time frame: 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.

Time frame: 3 months

Data from ClinicalTrials.gov

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