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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03313960
• Other study ID #: A-One
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 5, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2019
• Source: Informed Data Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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).

Locations

Country	Name	City	State
United States	One Drop	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Informed Data Systems, Inc.	Mannkind Corporation

Country where clinical trial is conducted

United States, 

References & Publications (22)

Baek RN, Tanenbaum ML, Gonzalez JS. Diabetes burden and diabetes distress: the buffering effect of social support. Ann Behav Med. 2014 Oct;48(2):145-55. doi: 10.1007/s12160-013-9585-4. — View Citation

Balkrishnan R, Rajagopalan R, Camacho FT, Huston SA, Murray FT, Anderson RT. Predictors of medication adherence and associated health care costs in an older population with type 2 diabetes mellitus: a longitudinal cohort study. Clin Ther. 2003 Nov;25(11):2958-71. — View Citation

Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes. 2007 Oct 10;5:57. — View Citation

Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care. 2004 May;27(5):1218-24. Review. — View Citation

Davies MJ, Gagliardino JJ, Gray LJ, Khunti K, Mohan V, Hughes R. Real-world factors affecting adherence to insulin therapy in patients with Type 1 or Type 2 diabetes mellitus: a systematic review. Diabet Med. 2013 May;30(5):512-24. doi: 10.1111/dme.12128. Review. — View Citation

Feldman BS, Cohen-Stavi CJ, Leibowitz M, Hoshen MB, Singer SR, Bitterman H, Lieberman N, Balicer RD. Defining the role of medication adherence in poor glycemic control among a general adult population with diabetes. PLoS One. 2014 Sep 26;9(9):e108145. doi: 10.1371/journal.pone.0108145. eCollection 2014. — View Citation

Gonzalez JS, Schneider HE, Wexler DJ, Psaros C, Delahanty LM, Cagliero E, Safren SA. Validity of medication adherence self-reports in adults with type 2 diabetes. Diabetes Care. 2013 Apr;36(4):831-7. doi: 10.2337/dc12-0410. Epub 2012 Nov 30. — View Citation

Gonzalez JS, Shreck E, Psaros C, Safren SA. Distress and type 2 diabetes-treatment adherence: A mediating role for perceived control. Health Psychol. 2015 May;34(5):505-13. doi: 10.1037/hea0000131. Epub 2014 Aug 11. — View Citation

Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, Magid DJ. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006 Sep 25;166(17):1836-41. — View Citation

Lerman I, Díaz JP, Ibarguengoitia ME, Pérez FJ, Villa AR, Velasco ML, Cruz RG, Rodrigo JA. Nonadherence to insulin therapy in low-income, type 2 diabetic patients. Endocr Pract. 2009 Jan-Feb;15(1):41-6. — View Citation

Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26. — View Citation

McPherson ML, Smith SW, Powers A, Zuckerman IH. Association between diabetes patients' knowledge about medications and their blood glucose control. Res Social Adm Pharm. 2008 Mar;4(1):37-45. doi: 10.1016/j.sapharm.2007.01.002. — View Citation

Nuffer W, Trujillo JM, Ellis SL. Technosphere insulin (Afrezza): a new, inhaled prandial insulin. Ann Pharmacother. 2015 Jan;49(1):99-106. doi: 10.1177/1060028014554648. Epub 2014 Oct 13. Review. — View Citation

Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Factors associated with injection omission/non-adherence in the Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabetes Obes Metab. 2012 Dec;14(12):1081-7. doi: 10.1111/j.1463-1326.2012.01636.x. Epub 2012 Jul 17. — View Citation

Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x. — View Citation

Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care. 2010 Feb;33(2):240-5. doi: 10.2337/dc09-1348. — View Citation

Piette JD, Wagner TH, Potter MB, Schillinger D. Health insurance status, cost-related medication underuse, and outcomes among diabetes patients in three systems of care. Med Care. 2004 Feb;42(2):102-9. — View Citation

Pittas AG, Westcott GP, Balk EM. Efficacy, safety, and patient acceptability of Technosphere inhaled insulin for people with diabetes: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2015 Nov;3(11):886-94. doi: 10.1016/S2213-8587(15)00280-6. Epub 2015 Sep 1. Review. — View Citation

Rosenstock J, Franco D, Korpachev V, Shumel B, Ma Y, Baughman R, Amin N, McGill JB; Affinity 2 Study Group. Inhaled Technosphere Insulin Versus Inhaled Technosphere Placebo in Insulin-Naïve Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetes Agents. Diabetes Care. 2015 Dec;38(12):2274-81. doi: 10.2337/dc15-0629. Epub 2015 Aug 7. — View Citation

Ross SA, Tildesley HD, Ashkenas J. Barriers to effective insulin treatment: the persistence of poor glycemic control in type 2 diabetes. Curr Med Res Opin. 2011 Nov;27 Suppl 3:13-20. doi: 10.1185/03007995.2011.621416. Epub 2011 Sep 23. — View Citation

Rubin RR, Peyrot M, Kruger DF, Travis LB. Barriers to insulin injection therapy: patient and health care provider perspectives. Diabetes Educ. 2009 Nov-Dec;35(6):1014-22. doi: 10.1177/0145721709345773. — View Citation

Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	3-month between-group change in A1c assessed by a central lab	3 months
Secondary	Insulin Device Satisfaction	Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS)	3 months
Secondary	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).	3 months
Secondary	Self-care	Within- and between-group change in self-care assessed by the SDSCA's other subscales	3 months
Secondary	Health-related Productivity	Within- and between-group change in health-related productivity assessed by the Work Productivity and Activity Impairment measure (WPAI).	3 months
Secondary	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.	3 months