Diabetes Mellitus, Type 2Phase 4NCT03313960

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

A Phase 4 study testing Afrezza plus One Drop | Premium and One Drop | Premium in people with Diabetes Mellitus, Type 2, run by Informed Data Systems, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Afrezza plus One Drop | Premium and One Drop | Premium
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2017to 30 Dec 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

One Drop
New York, New York, 10002

Other trials in United States

About this study

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

Read the 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).

Conditions: Diabetes Mellitus, Type 2
Being tested: Afrezza plus One Drop | Premium, One Drop | Premium
Keywords: Diabetes Mellitus, Type 2, Afrezza
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Afrezza plus One Drop | PremiumDrug
Also called insulin inhalation
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).
One Drop | PremiumOther
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).

Study groups in NCT03313960
Study group	Role	What they receive
One Drop \| Premium with Afrezza	Active comparator	Not described Receives: Drug: Afrezza plus One Drop \| Premium
One Drop \| Premium without Afrezza	Other	Not described Receives: Other: One Drop \| Premium

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin A1c
3-month between-group change in A1c assessed by a central lab
Measured: 3 months

Secondary outcomes (5)

Insulin Device Satisfaction
Within- and between-group change in insulin device satisfaction assessed by the Insulin Device Satisfaction Survey (IDSS)
Measured: 3 months
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).
Measured: 3 months
Self-care
Within- and between-group change in self-care assessed by the SDSCA's other subscales
Measured: 3 months
Health-related Productivity
Within- and between-group change in health-related productivity assessed by the Work Productivity and Activity Impairment measure (WPAI).
Measured: 3 months
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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 201730 Dec 2019

First posted19 Oct 2017
Study start5 Oct 2017
Primary completion30 Sep 2018
Study completion30 Dec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03313960
Sponsor's protocol ID: A-One
Status last verified: Feb 2019
First submitted: 10 Oct 2017
Last updated: 26 Feb 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No IPD will be shared

Publications

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.
PubMed 15111553
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.
PubMed 23323988
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.
PubMed 25259843
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.
PubMed 14734946
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.
PubMed 14693318
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.
PubMed 17000939
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.
PubMed 22313123
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.
PubMed 19211396
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.
PubMed 20103556
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.
PubMed 22726104
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.
PubMed 19934459
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.
PubMed 21942467
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.
PubMed 24550072
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.
PubMed 25110840
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.
PubMed 25313261

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A-One: A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone
ClinicalTrials.gov ID: NCT03313960
Acronym / sponsor ID: A-One
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2, Afrezza
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Informed Data Systems, Inc.Industry (pharma, biotech, devices)
Collaborators: Mannkind Corporation
Study start: 5 Oct 2017 (actual)
Primary completion: 30 Sep 2018 (actual)
Study completion: 30 Dec 2019 (estimated)
First posted: 19 Oct 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
One Drop \| Premium with Afrezza	Active comparator	Drug: Afrezza plus One Drop \| Premium
One Drop \| Premium without Afrezza	Other	Other: One Drop \| Premium

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Afrezza plus One Drop \| PremiumAlso: insulin inhalationParticipants 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).	Drug	One Drop \| Premium with Afrezza
One Drop \| PremiumParticipants 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).	Other	One Drop \| Premium without Afrezza

Primary outcome

Hemoglobin A1c
Time frame: 3 months
3-month between-group change in A1c assessed by a central lab

5 secondary outcomes

Insulin Device Satisfaction
Time frame: 3 months
Treatment Adherence
Time frame: 3 months
Self-care
Time frame: 3 months
Health-related Productivity
Time frame: 3 months
Health-related Quality of Life
Time frame: 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
Background: PubMed 15111553Cramer 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.
Background: PubMed 23323988Davies 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.
Background: PubMed 25259843Feldman 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.
Background: PubMed 14734946Piette 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.
Background: PubMed 14693318Balkrishnan 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.
Background: PubMed 17000939Ho 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.
Background: PubMed 22313123Peyrot 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.
Background: PubMed 19211396Lerman 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.
Background: PubMed 20103556Peyrot 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.
Background: PubMed 22726104Peyrot 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.
Background: PubMed 19934459Rubin 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.
Background: PubMed 21942467Ross 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.
Individual participant dataSharing planned: No. No IPD will be shared

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chandra Osborn, PhD, MPH principal investigator

Informed Data Systems, Inc. | One Drop

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Afrezza plus One Drop | Premium and One Drop | Premium in people with Diabetes Mellitus, Type 2, run by Informed Data Systems, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03313960, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.