Update on the General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) trial: statistical analysis plan for a multi-centre randomised controlled trial.
Adolescent
Adult
Aged
Aged, 80 and over
Australia
Biomarkers
/ blood
Blood Glucose
/ metabolism
Blood Glucose Self-Monitoring
/ methods
Data Interpretation, Statistical
Diabetes Mellitus, Type 2
/ blood
Female
General Practice
/ statistics & numerical data
Glycated Hemoglobin
/ metabolism
Humans
Male
Middle Aged
Multicenter Studies as Topic
Predictive Value of Tests
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome
Young Adult
General practice
Randomised controlled trial
Retrospective continuous glucose monitoring
Statistical analysis plan
Type 2 diabetes
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
30 Jan 2019
30 Jan 2019
Historique:
received:
08
09
2018
accepted:
11
12
2018
entrez:
1
2
2019
pubmed:
1
2
2019
medline:
29
5
2019
Statut:
epublish
Résumé
General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermittent retrospective continuous glucose monitoring (r-CGM) to usual care in patients with type 2 diabetes attending general practice. The study protocol was published in the British Medical Journal Open and described the principal features of the statistical methods that will be used to analyse the trial data. This paper provides greater detail on the statistical analysis plan, including background and justification for the statistical methods chosen, in accordance with SPIRIT guidelines. To describe in detail the data management process and statistical methods that will be used to analyse the trial data. An overview of the trial design and primary and secondary research questions are provided. Sample size assumptions and calculations are explained, and randomisation and data management processes are described in detail. The planned statistical analyses for primary and secondary outcomes and sub-group analyses are specified along with the intended table layouts for presentation of the results. In accordance with best practice, all analyses outlined in the document are based on the aims of the study and have been pre-specified prior to the completion of data collection and outcome analyses. Australian New Zealand Clinical Trials Registry, ACTRN12616001372471 . Registered on 3 August 2016.
Sections du résumé
BACKGROUND
BACKGROUND
General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermittent retrospective continuous glucose monitoring (r-CGM) to usual care in patients with type 2 diabetes attending general practice. The study protocol was published in the British Medical Journal Open and described the principal features of the statistical methods that will be used to analyse the trial data. This paper provides greater detail on the statistical analysis plan, including background and justification for the statistical methods chosen, in accordance with SPIRIT guidelines.
OBJECTIVE
OBJECTIVE
To describe in detail the data management process and statistical methods that will be used to analyse the trial data.
METHODS
METHODS
An overview of the trial design and primary and secondary research questions are provided. Sample size assumptions and calculations are explained, and randomisation and data management processes are described in detail. The planned statistical analyses for primary and secondary outcomes and sub-group analyses are specified along with the intended table layouts for presentation of the results.
CONCLUSION
CONCLUSIONS
In accordance with best practice, all analyses outlined in the document are based on the aims of the study and have been pre-specified prior to the completion of data collection and outcome analyses.
TRIAL REGISTRATION
BACKGROUND
Australian New Zealand Clinical Trials Registry, ACTRN12616001372471 . Registered on 3 August 2016.
Identifiants
pubmed: 30700324
doi: 10.1186/s13063-018-3126-1
pii: 10.1186/s13063-018-3126-1
pmc: PMC6354399
doi:
Substances chimiques
Biomarkers
0
Blood Glucose
0
Glycated Hemoglobin A
0
hemoglobin A1c protein, human
0
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
93Subventions
Organisme : National Health and Medical Research Council
ID : 1104241
Organisme : Sanofi Australia
ID : N/A
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