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

February 25, 2019 updated by: Chandra Osborn, PhD, MPH, Informed Data Systems, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10002
        • One Drop

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: One Drop | Premium with Afrezza
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 without Afrezza
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 3 months
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
Time Frame: 3 months
Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS)
3 months
Treatment Adherence
Time Frame: 3 months
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
Time Frame: 3 months
Within- and between-group change in self-care assessed by the SDSCA's other subscales
3 months
Health-related Productivity
Time Frame: 3 months
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
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Informed Data Systems, Inc.

Collaborators

Mannkind Corporation

Investigators

  • Principal Investigator: Chandra Osborn, PhD, MPH, Informed Data Systems, Inc. | One Drop

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2017

Primary Completion (ACTUAL)

September 30, 2018

Study Completion (ANTICIPATED)

December 30, 2019

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 13, 2017

First Posted (ACTUAL)

October 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-One

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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