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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Afrezza plus One Drop | Premium

One Drop | Premium

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Afrezza

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

One Drop

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

One Drop | Premium with Afrezza

One Drop | Premium without Afrezza

Arm Description

Outcomes

Primary Outcome Measures

Hemoglobin A1c

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

Secondary Outcome Measures

Insulin Device Satisfaction

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

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).

Self-care

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

Health-related Productivity

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

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.

Full Information

NCT ID

NCT03313960

First Posted

October 10, 2017

Last Updated

February 25, 2019

Sponsor

Informed Data Systems, Inc.

Collaborators

Mannkind Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03313960

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 5, 2017 (Actual)

Primary Completion Date

September 30, 2018 (Actual)

Study Completion Date

December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Informed Data Systems, Inc.

Collaborators

Mannkind Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2, Afrezza

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

One Drop | Premium with Afrezza

Arm Type

Active Comparator

Arm Title

One Drop | Premium without Afrezza

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Afrezza plus One Drop | Premium

Other Intervention Name(s)

insulin inhalation

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

One Drop | Premium

Intervention Description

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).

Primary Outcome Measure Information:

Title

Hemoglobin A1c

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Insulin Device Satisfaction

Description

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

Time Frame

3 months

Title

Treatment Adherence

Description

Time Frame

3 months

Title

Self-care

Description

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

Time Frame

3 months

Title

Health-related Productivity

Description

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

Time Frame

3 months

Title

Health-related Quality of Life

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chandra Osborn, PhD, MPH

Organizational Affiliation

Informed Data Systems, Inc. | One Drop

Official's Role

Principal Investigator

Facility Information:

Facility Name

One Drop

City

New York

State/Province

New York

ZIP/Postal Code

10002

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No IPD will be shared

Citations:

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Citation

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Learn more about this trial

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

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