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

NCT03313960 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

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).

Sponsors & Collaborators

  • Mannkind Corporation

    collaborator INDUSTRY

  • Informed Data Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Chandra Osborn, PhD, MPH · Informed Data Systems, Inc. | One Drop

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2018-09-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313960 on ClinicalTrials.gov