One drop study Changes

[kimi]

clinicaltrials.gov/archive/NCT03313960/2018_02_12/changes
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<clinical_study>
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NCT03313960
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2017-10

2018-02
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2019-02-01

2019-09-30
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2018-02-01

2018-09-30
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2017-10-13

2018-02-12
clinicaltrials.gov/archive/NCT03313960/2018_02_18/changes
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(Updated 2018_02_12)

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<clinical_study>
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<clinical_study>
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The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium &apos;On Track&apos; 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) of 7.5-10.5% already prescribed an injectable rapid-acting insulin.

The A-One study is a prospective, randomized controlled trial evaluating the use of the One Drop | Premium &apos;On Track&apos; 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) &gt; 7.0% already prescribed an injectable rapid-acting insulin.
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Eligible participants (N=400) with an A1c 7.5-10.5% already prescribed a rapid-acting insulin will be randomized to one of two groups: (1) One Drop | Premium &apos;On Track&apos; (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 &apos;Chrome&apos; 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 &apos;On Track&apos; plus their current rapid-acting insulin (n=200).

Eligible participants (N=400) with an A1c &gt; 7.0% already prescribed a rapid-acting insulin will be randomized to one of two groups: (1) One Drop | Premium &apos;On Track&apos; (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 &apos;Chrome&apos; 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 &apos;On Track&apos; plus their current rapid-acting insulin (n=200).
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- Willing to get a physician&apos;s prescription for Afrezza
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- Willing to get a physician&apos;s prescription for Afrezza
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- Self-reported A1c 7.5-10.5% (later confirmed with a mail-in A1c laboratory test)

- Self-reported A1c &gt; 7.0% (later confirmed with a mail-in A1c laboratory test)
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- Owns and uses an iPhone or Android phone with an operating system compatible with the One Drop | Mobile app
- Had previously used or is currently using Afrezza
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- Owns and uses an iPhone or Android phone with an operating system compatible with the One Drop | Mobile app
- Had previously used or is currently using Afrezza
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- Currently smokes (cigaretts, e-cigs, pipes, cigars, marijuana) or has smoked anytime in the past 6 months
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- Has chronic lung disease, e.g., COPD and asthma
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- Has chronic lung disease, e.g., COPD and asthma
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2017-10-10

2017:10:10:18:01:20:356
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</initial_release_date>
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2018-02-12

2018:02:15:10:57:52:174
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[mnholdem]

Trial eligibility changed from a1C of 7.5-10.5 to simply greater than 7.0 a1C plus smokers are now ineligible.

[brotherm1]

And I was thinking this trial had already started

[mnholdem]

I has. ClinicalTrials.gove reports that the trials Actual Start Date was on October 5, 2017. This latest update is simply tweaking, IMO.

[agedhippie]

Feb 20, 2018 7:41:27 GMT -5 brotherm1 said:

And I was thinking this trial had already started

It has started, but it's in the recruiting phase. Recruiting can take a while when you are after 400 participants which is probably why the date slipped.

[liane]

Recruitment is usually on a rolling basis - start the participants whenever you recruit them.

[brotherm1]

“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.”

It would certainly be great to be clairvoyant to see how many have started with the trial and what we have learned relating to “treatment adherence, social-cognitive barriers to adherence...”

[peppy]

Feb 20, 2018 9:54:38 GMT -5 brotherm1 said:

“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.”

It would certainly be great to be clairvoyant to see how many have started with the trial and what we have learned relating to “treatment adherence, social-cognitive barriers to adherence...”

Out of sight, out of mind.

[kimi]

Status Recruiting
Start date 2017-10-05 (Actual)
Last follow-up date 2019-09-30 (Anticipated)
Primary completion date 2018-09-30 (Anticipated) was 2018-02-01

[dreamboatcruise]

Feb 20, 2018 5:19:49 GMT -5 mnholdem said:

Trial eligibility changed from a1C of 7.5-10.5 to simply greater than 7.0 a1C plus smokers are now ineligible.

That was a bit of an oversight if they had not already excluded smokers.  Can't just exclude them from the Afrezza arm.

[digger]

Am I understanding it correctly -- "or (2) One Drop | Premium 'On Track' plus their current rapid-acting insulin" -- so they're trying to track down 200 type 2s who are also taking a RAA? That seems like it would be difficult since relatively few reach the RAA stage.

[dreamboatcruise]

Feb 21, 2018 0:53:32 GMT -5 digger said:

Am I understanding it correctly -- "or (2) One Drop | Premium 'On Track' plus their current rapid-acting insulin" -- so they're trying to track down 200 type 2s who are also taking a RAA? That seems like it would be difficult since relatively few reach the RAA stage.

It's still a huge population due to how many people develop T2.

[sayhey24]

Feb 21, 2018 0:53:32 GMT -5 digger said:

Am I understanding it correctly -- "or (2) One Drop | Premium 'On Track' plus their current rapid-acting insulin" -- so they're trying to track down 200 type 2s who are also taking a RAA? That seems like it would be difficult since relatively few reach the RAA stage.

I have never fully understood this study.  The primary objective is a 3-month between-group change in A1c assessed by a central lab.
They are not using a CGM but rather the One Drop meter so they are not tracking time in range.

I theory you would expect the RAA group to improve due to the coaching and the afrezza group do the same.  I would expect the overall A1c to be about the same but the afrezza group to have better time in range but they are not measuring that.

Overall I think the study is more to promote One Drop coaching.  This study Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients  always made more sense showing the value of afrezza and I bet was a lot easier to recruit for.

clinicaltrials.gov/ct2/show/NCT03324776

[dreamboatcruise]

sayhey24 ... many here have speculated that it was the poor design of the clinical trials (dose titration or lack thereof, timing, and lack of follow ups if out of range) that lead to being merely non-inferior with regard to A1c. I would assume that MNKD believes this and would expect with proper coaching from One Drop, the Afrezza arm will show superior A1c results. I do believe that for a given level of hypo risk, a lower A1c is achievable with Afrezza... in a general population, i.e. not withstanding the subset of people willing to closely tailor their food consumption to match pd profile of their RAA.

[lennymnkd]

“ I️ do believe for a certain level of hypo risk “ what might that risk be in quantitative terms ?