Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Afrezza
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).
Interventions
DRUGAfrezza 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).
OTHEROne 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
Mannkind Corporation
Informed Data Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 3 months | 3-month between-group change in A1c assessed by a central lab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Device Satisfaction | 3 months | Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS) |
| Treatment Adherence | 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). |
| Self-care | 3 months | Within- and between-group change in self-care assessed by the SDSCA's other subscales |
| Health-related Productivity | 3 months | Within- and between-group change in health-related productivity assessed by the Work Productivity and Activity Impairment measure (WPAI). |
| Health-related Quality of Life | 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. |
Countries
United States
Outcome results
None listed