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Trial record 3 of 4 for:    mannkind | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation, Suspended Studies

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

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ClinicalTrials.gov Identifier: NCT03313960
Recruitment Status : Active, not recruiting
First Posted : October 19, 2017
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Mannkind Corporation
Information provided by (Responsible Party):
Chandra Osborn, PhD, MPH, Informed Data Systems, Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Afrezza plus One Drop | Premium Other: One Drop | Premium Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A-One: A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
Actual Study Start Date : October 5, 2017
Actual Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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 Name: insulin inhalation

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).




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 3 months ]
    3-month between-group change in A1c assessed by a central lab


Secondary Outcome Measures :
  1. Insulin Device Satisfaction [ Time Frame: 3 months ]
    Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS)

  2. 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. Self-care [ Time Frame: 3 months ]
    Within- and between-group change in self-care assessed by the SDSCA's other subscales

  4. 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).

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313960


Locations
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United States, New York
One Drop
New York, New York, United States, 10002
Sponsors and Collaborators
Informed Data Systems, Inc.
Mannkind Corporation
Investigators
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Principal Investigator: Chandra Osborn, PhD, MPH Informed Data Systems, Inc. | One Drop

Publications:

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Responsible Party: Chandra Osborn, PhD, MPH, Vice President, Health & Behavioral Informatics, Informed Data Systems, Inc.
ClinicalTrials.gov Identifier: NCT03313960     History of Changes
Other Study ID Numbers: A-One
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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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

Keywords provided by Chandra Osborn, PhD, MPH, Informed Data Systems, Inc.:
Diabetes Mellitus, Type 2
Afrezza

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs