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

NCT03313960 | Unknown Phase 4 FDA Drug

• 1 other identifier: A-One
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Afrezza

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

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

  3 months

Secondary Outcomes (5)

• Insulin Device Satisfaction

  3 months

• Treatment Adherence

  3 months

• Self-care

  3 months

• Health-related Productivity

  3 months

• Health-related Quality of Life

  3 months

Study Arms (2)

One Drop | Premium with Afrezza

ACTIVE COMPARATOR

Drug: Afrezza plus One Drop | Premium

One Drop | Premium without Afrezza

OTHER

Other: One Drop | Premium

Interventions

Afrezza plus One Drop | Premium DRUG

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).

Also known as: insulin inhalation

One Drop | Premium with Afrezza

One Drop | Premium OTHER

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).

One Drop | Premium without Afrezza

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Informed Data Systems, Inc.: lead
• Mannkind Corporation: collaborator

Study Sites (1)

One Drop

New York, New York, 10002, United States

Location

Related Publications (22)

• Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care. 2004 May;27(5):1218-24. doi: 10.2337/diacare.27.5.1218.

  PMID: 15111553 BACKGROUND

• 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.

  PMID: 23323988 BACKGROUND

• 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.

  PMID: 25259843 BACKGROUND

• 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. doi: 10.1097/01.mlr.0000108742.26446.17.

  PMID: 14734946 BACKGROUND

• 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. doi: 10.1016/s0149-2918(03)80347-8.

  PMID: 14693318 BACKGROUND

• 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. doi: 10.1001/archinte.166.17.1836.

  PMID: 17000939 BACKGROUND

• 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.

  PMID: 22313123 BACKGROUND

• Lerman I, Diaz JP, Ibarguengoitia ME, Perez 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. doi: 10.4158/EP.15.1.41.

  PMID: 19211396 BACKGROUND

• 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.

  PMID: 20103556 BACKGROUND

• 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.

  PMID: 22726104 BACKGROUND

• 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.

  PMID: 19934459 BACKGROUND

• 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.

  PMID: 21942467 BACKGROUND

• 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.

  PMID: 24550072 BACKGROUND

• 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.

  PMID: 25110840 BACKGROUND

• 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.

  PMID: 25313261 BACKGROUND

• 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.

  PMID: 26341170 BACKGROUND

• 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-Naive 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.

  PMID: 26253730 BACKGROUND

• 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.

  PMID: 18342821 BACKGROUND

• 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. doi: 10.1186/1477-7525-5-57.

  PMID: 17927832 BACKGROUND

• 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.

  PMID: 23204245 BACKGROUND

• 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.

  PMID: 24209600 BACKGROUND

• 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. doi: 10.2337/diacare.23.7.943.

  PMID: 10895844 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chandra Osborn, PhD, MPH

  Informed Data Systems, Inc. | One Drop

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President, Health & Behavioral Informatics

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 19, 2017
• Study Start: October 5, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)