Post by kimi on Feb 20, 2018 3:46:06 GMT -5
clinicaltrials.gov/archive/NCT03313960/2018_02_12/changes
Before
(Updated 2017_10_18)
[Next]
After
(Updated 2018_02_12)
1 [+]
<clinical_study>
<nct_id>
[+]
<clinical_study>
<nct_id>
2
NCT03313960
3 [+]
</nct_id>
<date>
[+]
</nct_id>
<date>
4
2017-10
2018-02
5 [+]
</date>
<date>
[+]
</date>
<date>
6
2019-02-01
2019-09-30
7 [+]
</date>
<date>
[+]
</date>
<date>
8
2018-02-01
2018-09-30
9 [+]
</date>
<last_release_date>
[+]
</date>
<last_release_date>
10
2017-10-13
2018-02-12
clinicaltrials.gov/archive/NCT03313960/2018_02_18/changes
Before
(Updated 2018_02_12)
After
(Updated 2018_02_18)
1 [+]
<clinical_study>
<textblock>
[+]
<clinical_study>
<textblock>
2
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) 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 '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.
3 [+]
</textblock>
<textblock>
[+]
</textblock>
<textblock>
4
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 '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).
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).
5 [+]
</textblock>
- Willing to get a physician's prescription for Afrezza
[+]
</textblock>
- Willing to get a physician's prescription for Afrezza
6
- Self-reported A1c 7.5-10.5% (later confirmed with a mail-in A1c laboratory test)
- Self-reported A1c > 7.0% (later confirmed with a mail-in A1c laboratory test)
7 [+]
- 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
[+]
- 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
8
- Currently smokes (cigaretts, e-cigs, pipes, cigars, marijuana) or has smoked anytime in the past 6 months
9 [+]
- Has chronic lung disease, e.g., COPD and asthma
<initial_release_date>
[+]
- Has chronic lung disease, e.g., COPD and asthma
<initial_release_date>
10
2017-10-10
2017:10:10:18:01:20:356
11
</initial_release_date>
<last_release_date>
</initial_release_date>
<last_release_date>
12
2018-02-12
2018:02:15:10:57:52:174
13 [+]
</last_release_date>
</clinical_study>
[+]
</last_release_date>
</clinical_study>
Before
(Updated 2017_10_18)
[Next]
After
(Updated 2018_02_12)
1 [+]
<clinical_study>
<nct_id>
[+]
<clinical_study>
<nct_id>
2
NCT03313960
3 [+]
</nct_id>
<date>
[+]
</nct_id>
<date>
4
2017-10
2018-02
5 [+]
</date>
<date>
[+]
</date>
<date>
6
2019-02-01
2019-09-30
7 [+]
</date>
<date>
[+]
</date>
<date>
8
2018-02-01
2018-09-30
9 [+]
</date>
<last_release_date>
[+]
</date>
<last_release_date>
10
2017-10-13
2018-02-12
clinicaltrials.gov/archive/NCT03313960/2018_02_18/changes
Before
(Updated 2018_02_12)
After
(Updated 2018_02_18)
1 [+]
<clinical_study>
<textblock>
[+]
<clinical_study>
<textblock>
2
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) 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 '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.
3 [+]
</textblock>
<textblock>
[+]
</textblock>
<textblock>
4
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 '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).
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).
5 [+]
</textblock>
- Willing to get a physician's prescription for Afrezza
[+]
</textblock>
- Willing to get a physician's prescription for Afrezza
6
- Self-reported A1c 7.5-10.5% (later confirmed with a mail-in A1c laboratory test)
- Self-reported A1c > 7.0% (later confirmed with a mail-in A1c laboratory test)
7 [+]
- 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
[+]
- 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
8
- Currently smokes (cigaretts, e-cigs, pipes, cigars, marijuana) or has smoked anytime in the past 6 months
9 [+]
- Has chronic lung disease, e.g., COPD and asthma
<initial_release_date>
[+]
- Has chronic lung disease, e.g., COPD and asthma
<initial_release_date>
10
2017-10-10
2017:10:10:18:01:20:356
11
</initial_release_date>
<last_release_date>
</initial_release_date>
<last_release_date>
12
2018-02-12
2018:02:15:10:57:52:174
13 [+]
</last_release_date>
</clinical_study>
[+]
</last_release_date>
</clinical_study>