Clinical Trial Results:
A 21-Week, Open-label, Randomized, Controlled, Parallel-group, Multi-center Study Evaluating the Efficacy and Safety of HOE901-U300 Administered According to a Device-Supported Treat-to-target Regimen Versus Routine Titration in Patients with Type 2 Diabetes Mellitus
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Summary
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EudraCT number |
2014-004533-13 |
Trial protocol |
GB DE AT |
Global end of trial date |
30 Nov 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Dec 2017
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First version publication date |
15 Dec 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EFC13470
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02585674 | ||
WHO universal trial number (UTN) |
U1111-1165-9001 | ||
Other trial identifiers |
Study Name: AUTOMATIX | ||
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Sponsors
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Sponsor organisation name |
Sanofi aventis recherche & développement
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Sponsor organisation address |
1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
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Public contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Jan 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate the non-inferiority of the MyStar DoseCoach (Long-acting Insulin Glargine Titration Meter) device-supported treat-to-target regimen relative to a routine titration regimen in the percentage of patients reaching glycemic target, ie, with a mean fasting self-monitored plasma glucose (FSMPG) value within the target range of 90-130 mg/dL (5.0-7.2 mmol/L) without a severe hypoglycemic episode during the 16-week on-treatment period.
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Protection of trial subjects |
Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency.
Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
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Background therapy |
Glucose lowering therapy (such as metformin, sulphonylureas, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-IV inhibitors) kept stable for at least 3 months prior to screening and also, throughout the study unless there was a specific safety issue related to this treatment. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Dec 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 57
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Country: Number of subjects enrolled |
Germany: 94
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Worldwide total number of subjects |
151
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EEA total number of subjects |
151
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
85
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From 65 to 84 years |
66
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 19 centres in 2 countries. A total of 203 subjects were screened between 9 December 2015 and 12 July 2016 of whom 52 subjects were screen failures. Screen failures were mainly due to exclusion criteria met. | ||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 151 subjects were randomized in a 1:1 ratio to use either the Dose Helper function of the MyStar DoseCoach or the usual titration method provided by the investigator. The randomization was stratified by previous use of insulin (insulin-naïve versus non-insulin-naïve). | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dose Helper Titration | ||||||||||||||||||
Arm description |
Subjects used the dose helper functionality of the MyStarDoseCoach device for basal insulin titration. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Insulin glargine
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Investigational medicinal product code |
HOE901
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Other name |
Toujeo®
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
HOE901-U300 self-administered by deep SC injection at approximately the same time every day. Dose was individually titrated to achieve target fasting SMPG range equal to 90-130 mg/dL (5.0-7.2 mmol/L) while avoiding hypoglycemia.
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Arm title
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Routine Titration | ||||||||||||||||||
Arm description |
Subjects followed the usual method of titration that was recommended by the investigator. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Insulin glargine
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Investigational medicinal product code |
HOE901
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Other name |
Toujeo®
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
HOE901-U300 self-administered by deep SC injection at approximately the same time every day. Dose was individually titrated based on usual method recommended by investigator.
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| Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Out of 75 subjects, 17 subjects stopped prematurely the dose helper. [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Milestone not applicable for this arm as subjects did not use the dose helper. |
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Baseline characteristics reporting groups
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Reporting group title |
Dose Helper Titration
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Reporting group description |
Subjects used the dose helper functionality of the MyStarDoseCoach device for basal insulin titration. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Routine Titration
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Reporting group description |
Subjects followed the usual method of titration that was recommended by the investigator. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dose Helper Titration
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Reporting group description |
Subjects used the dose helper functionality of the MyStarDoseCoach device for basal insulin titration. | ||
Reporting group title |
Routine Titration
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Reporting group description |
Subjects followed the usual method of titration that was recommended by the investigator. | ||
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End point title |
Percentage of Subjects Reaching Mean Fasting Self-Monitored Plasma Glucose (FSMPG) Target range of 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 Without Severe Hypoglycemia During the 16 Week On- Treatment Period | ||||||||||||
End point description |
Estimated percentages from multiple imputation approach. Mean FSMPG values at Week 16 time-point was calculated by the mean of the last 5 on-treatment readings recorded over the 2 weeks preceding the Week 16 time-point (Day 112), using the relative days from the first investigational medicinal product (IMP) dose. Severe hypoglycemia was an event that required assistance of another person to actively administered carbohydrate, glucagon, or other resuscitative actions. The 16-week on-treatment period for hypoglycemia occurs from first IMP up to 16 weeks defined by 112 days after the first IMP dose. Analysis was performed on modified intent-to-treat population (mITT) that included all randomized subjects treated with IMP and analysed according to the titration group allocated by randomization.
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End point type |
Primary
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End point timeframe |
First dose up to Day 112
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Statistical analysis title |
Dose Helper Titration vs. Routine Titration | ||||||||||||
Statistical analysis description |
Estimated difference of percentage was obtained by combining the difference (diff.) in percentage, weighted by the randomization stratum of previous use of insulin (Insulin naive, Insulin pre-treated), between titration groups of all different imputed data sets, using Rubin's formulae.
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Comparison groups |
Routine Titration v Dose Helper Titration
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Number of subjects included in analysis |
151
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||
Method |
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Parameter type |
Estimated weighted percentage difference | ||||||||||||
Point estimate |
9.04
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-6.748 | ||||||||||||
upper limit |
24.829 | ||||||||||||
| Notes [1] - To assess non-inferiority the lower bound of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects between MyStar DoseCoach and routine titration of the primary endpoint must be strictly greater to the predefined non-inferiority margin of -15%. Only if non-inferiority of MyStar DoseCoach versus routine titration regimen had been demonstrated, step 2 was to test superiority of MyStar DoseCoach over routine titration. |
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Statistical analysis title |
Dose Helper Titration vs Routine Titration | ||||||||||||
Statistical analysis description |
Step-2 was to test superiority of MyStar DoseCoach over routine titration. Only if non inferiority was demonstrated, the superiority of Dose Helper titration versus routine titration was demonstrated if the lower bound of the two-sided 95% CI for the weighted difference (diff.) in the percentage of subjects between titration arms was >0 (zero).
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Comparison groups |
Dose Helper Titration v Routine Titration
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Number of subjects included in analysis |
151
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.2618 | ||||||||||||
Method |
Weighted diff. from multiple imputation | ||||||||||||
Parameter type |
Estimated weighted percentage difference | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-6.748 | ||||||||||||
upper limit |
24.829 | ||||||||||||
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End point title |
Percentage of Subjects Reaching Mean FSMPG Target Range of 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 Without Severe and/or Confirmed Hypoglycemic Episode During the 16-Week On-Treatment Period | ||||||||||||||||||
End point description |
Estimated percentages from multiple imputation approach. Mean FSMPG values at Week 16 time-point was calculated by the mean of the last 5 on-treatment readings recorded over the 2 weeks preceding the Week 16 time-point (Day 112) using the relative days from the first IMP dose. Severe and/or Confirmed hypoglycemia event was a severe event or an event defined as plasma glucose ≤70 mg/dL (3.9 mmol/L) or <54 mg/dL (3.0 mmol/L). The 16-week on-treatment period for hypoglycemia occurs from first IMP up to 16 weeks defined by 112 days after the first IMP dose. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
First dose up to Day 112
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percentage of Subjects Reaching Mean FSMPG Target Range of 70-130 mg/dL (3.9-7.2 mmol/L) at Week 16 Without Severe Hypoglycemic Episode During the 16-Week On-Treatment Period | ||||||||||||
End point description |
Estimated percentages from multiple imputation approach. Mean FSMPG values at Week 16 time-point was calculated by the mean of the last 5 on-treatment readings recorded over the 2 weeks preceding the Week 16 time-point (Day 112) using the relative days from the first IMP dose. The 16-week on-treatment period for hypoglycemia occurs from first IMP up to 16 weeks defined by 112 days after the first IMP dose. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
First dose up to Day 112
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Reaching Mean FSMPG Target Range of 70-130 mg/dL (3.9-7.2 mmol/L) at Week 16 Without Severe and/or Confirmed Hypoglycemic Episode During 16-Week On-Treatment Period | ||||||||||||||||||
End point description |
Estimated percentages from multiple imputation approach. Mean FSMPG values at Week 16 time-point was calculated by the mean of the last 5 on-treatment readings recorded over the 2 weeks preceding the Week 16 time-point (Day 112) using the relative days from the first IMP dose. The 16-week on-treatment period for hypoglycemia occurs from first IMP up to 16 weeks defined by 112 days after the first IMP dose. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
First dose up to Day 112
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Change From Baseline in Mean FSMPG at Week 16 During the On-Treatment Period | ||||||||||||
End point description |
Change in FSMPG was calculated by subtracting baseline value from Week 16 time point value. Adjusted LS means from mixed-effect model with repeated measures. Mean FSMPG values were calculated by the mean of the last 5 on-treatment readings recorded over the 2 weeks preceding the corresponding time-point, using the relative days from the first IMP. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 time point
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to First Reach Mean FSMPG Target Range During the On-Treatment Period | ||||||||||||
End point description |
The mean FSMPG was calculated by the mean of the last 5 on-treatment values recorded over each 2-weeks period defined by each time window of 14 consecutive days starting from first IMP date. Time to first mean FSMPG in target range was defined as the number of weeks from 1st IMP to the date of the first 2-weeks period where the mean FSMPG value was in the target. Median survival which corresponds to the duration for which 50% of the subjects reached the target, was estimated using Kaplan-Meier method. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
First dose of study drug up to 1 day after the last dose administration
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 During the On-Treatment Period | ||||||||||||
End point description |
Change in HbA1c value from baseline to visit week 16 was analysed using all post-baseline values recorded from first IMP up to 7 days after last IMP dose. Adjusted LS means from ANCOVA. Analysis was performed on mITT population. Here, Number of subjects analysed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 During the On-Treatment Period | |||||||||||||||
End point description |
Change in FPG value from baseline to visit Week 16 was analysed using all post-baseline values recorded from first IMP up to 1 day after last IMP dose. Adjusted LS means from mixed-effect model with repeated measures. Analysis was performed on mITT population. Here, Number of subjects analysed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 Visit
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Percentage of Subjects Reaching HbA1c of <7.5% and <7% at Week 16 During the On-Treatment Period | ||||||||||||||||||
End point description |
Only HbA1c values recorded from the first IMP dose up to 7 days after the last IMP dose were considered in the analysis. Subjects who had no available on-treatment assessment for HbA1c at visit Week 16 were considered as non-responders. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percentage of Subjects with FPG in the Target Range of [90-130 mg/dL] (5.0-7.2 mmol/L) at Week 16 Without Severe Hypoglycemia at Week 16 During the On-Treatment Period | ||||||||||||
End point description |
Only assessments reported from the first IMP dose up to 1 day after the last IMP dose for FPG values, and up to 2 days after the last IMP dose for hypoglycaemia events were considered in the analysis. Number of subjects with FPG in the target range of [90-130 mg/dL] (5.0-7.2 mmol/L) at visit Week 16 without severe hypoglycemia during the on-treatment period was analysed. Subjects who had no available on-treatment assessment for FPG at visit Week 16 were considered as non-responders . Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects with Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic Hypoglycemia, Asymptomatic Hypoglycemia and Severe and/or confirmed Hypoglycemia) During the On-Treatment Period | ||||||||||||||||||||||||||||||||||||
End point description |
Categories of hypoglycaemia event were based on ADA classification. Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia was an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analysed. Only events occurring from first IMP dose up to 2 days after last IMP dose were analysed. Analysis was performed on the safety population that included randomized population who actually received at least 1 dose or part of a dose of the IMP, analysed according to the titration regimen actually followed.
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End point type |
Secondary
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End point timeframe |
First dose of study drug up to 2 days after the last dose administration
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 16 | ||||||||||||
End point description |
The DTSQs is a validated questionnaire to assess subject’s satisfaction with their diabetes treatment. Total DTSQ score consists of the sum of 6 items (Q1 and Q4 - Q8), each rated on a 7-point scale (from 0 to 6). Total DTSQ score ranged from 0 (very dissatisfied) to 36 (very satisfied); higher score = more satisfaction. Change in total DTSQ score from baseline to visit Week 16 was performed on mITT population. Adjusted LS means from ANCOVA. Number of subjects analysed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in the Total Hypoglycemia Fear Survey Score at Week 16 | ||||||||||||
End point description |
Hypoglycemia fear survey (HFS), is a validated tool to assess subject’s fear and behavior relative to hypoglycemia. It consists of 33 items each rated on a 5-point scale ranges from 0= never to 4= always. Total HFS score (mean of the 33 items) ranged from 0 to 4 higher score reflects increasing fear of hypoglycaemia. Change in total HFS score from baseline to visit Week 16 was performed on mITT population. Adjusted LS means from ANCOVA. Number of subjects analysed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in the World Health Organization-5 (WHO-5) Well-Being Index Score at Week 16 | ||||||||||||
End point description |
The WHO-5 well-being index is a standardized test to evaluate emotional well-being and quality of life. It contains five items each rated on a 6-point scale (from 0 to 5). The total WHO-5 score (sum of the 5 items multiplied by 4) range from 0 to 100 where higher score indicated the best quality of life. Change in total WHO-5 score from baseline to visit Week 16 was performed on mITT population. Adjusted LS means from ANCOVA. Number of subjects analysed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Total Diabetes Distress Scale Score to Week 16 | ||||||||||||
End point description |
The Diabetes distress scale (DDS) is a validated questionnaire that evaluates subject’s emotional distress related to diabetes disease burden. It consists of 17 questions, each rated on a 6-point scale (from 1 to 6). Total DDS score (mean of the 17 questions) ranged from 1 to 6. Higher score indicated greater emotional distress. Change in total DDS score from baseline to visit Week 16 was performed on mITT population. Adjusted LS means from ANCOVA. Number of subjects analysed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Total Glucose Monitoring Satisfaction (GMS) Score to Week 16 | ||||||||||||
End point description |
The GMS is a questionnaire assessing subject’s satisfaction with their glucose monitoring. It consists of 15 items, each rated on a 5-point scale (from 1 to 5). Total GMS score (mean of the 15 items) ranged from 1 to 5, higher score= greater level of satisfaction. Change in total GMS score from baseline to visit Week 16 was performed on mITT population. Adjusted LS means from ANCOVA. Number of subjects analysed = subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16 Visit
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Dose Helper Titration: Device Ease of Use Questionnaire at Week 16 [2] | ||||||||||||||||
End point description |
The device ease of use questionnaires were administered to health care providers (1 question) and subjects randomized to the dose helper titration arm (3 questions) at visit Week 16. The 4 questions of the MyStar DoseCoach ease of use questionnaires were rated on a 7-point scale ranges from 1 (extremely difficult) to 7 (extremely easy). Descriptive analysis of each question was performed on mITT population. Number of subjects analysed=subjects with available data for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 16 Visit
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| Notes [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: The end point is reporting results only for the arm applicable for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational product.
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Adverse event reporting additional description |
Analysed AEs are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (The on-treatment period was defined as the time from the first injection of open-label IMP up to 2 days after the last injection of IMP).
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
Dose Helper Titration
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Reporting group description |
Subjects used the dose helper functionality of the MyStarDoseCoach device for basal insulin titration. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Routine Titration
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Reporting group description |
Subjects followed the usual method of titration that was recommended by the investigator. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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14 Sep 2015 |
Following changes were made: - To ensure that only adult subjects were included in this clinical trial, who were able to understand the nature, significance and implications of the clinical trial and to form their intention accordingly. - To ensure that no subjects with high risk hypoglycemia and hypoglycemia with particularly severe outcome should be included in the trial. - This included especially subjects with stenosis of coronary artery or vessels supplying the brain as well as subjects with proliferative retinopathy. - To clarify to use Investigator Brochure and its addenda for reference safety information. - To clarify that any protocol amendment or modification was submitted to Health Authorities (Competent Regulatory Authority) before implementation. - To implement an additional objective/endpoint of satisfaction with glucose monitoring via addition of the Glucose Monitoring Satisfaction Survey (GMS). - To implement changes related to the classification of MyStar DoseCoach.
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
