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Clinical Trials

Reports of clinical trials will not be considered without a trial registration number. Randomised controlled trials must be accompanied by a completed CONSORT checklist (see below).

In accordance with guidelines issued by the International Committee of Medical Journal Editors (ICMJE), Diabetologia requires registration of clinical trials in a public trials registry at or before the time of first patient enrolment. A clinical trial is defined as any research project that prospectively assigns people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.

Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) do not require registration.

The ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform or in ClinicalTrials.gov.

The trial registry number should be included at the end of the Abstract.

Reports of randomised controlled trials (RCTs) should include the checklist items set out in the CONSORT guidelines, as well as a patient flow diagram. See CONSORT website for further details. Authors must submit a completed CONSORT 2010 checklist, along with the original trial protocol (including statistical analyses to be undertaken). For reports of non-pharmacological treatment interventions, please use the appropriate extension of the CONSORT statement.

For secondary analyses of RCTs or observational studies, please complete either a CONSORT or a STROBE checklist, as appropriate. Reference can be made in the checklist and the current paper to previous publications that describe the study in more detail. Any sections of the checklist that do not apply to the current study can be marked ‘not applicable’ (NA). Please note that a STROBE checklist might be more suitable where a cohort from a previous RCT is used to answer a different research question.

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