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. 2021 Mar 4;2021(3):CD013498. doi: 10.1002/14651858.CD013498.pub2

NCT00564018.

Methods Allocation: randomised
Intervention model: parallel‐group assignment
Masking: open‐label
Primary purpose: treatment
Participants Condition: T1DM
Estimated number of participants: 33
Inclusion criteria: newly diagnosed T1DM within 1 week of diagnosis; age 6 to 18 years
Exclusion criteria: actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycaemic agents); actual treatment with drugs influencing insulin sensitivity (e.g. metformin or systemic steroids); significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry); expected poor compliance; pregnancy; any other condition that by the judgement of the investigator may be potentially harmful to the patients
Interventions Intervention(s): detemir
Comparator (1): glargine
Comparator (2): NPH
Duration of the intervention: planned to 1 year (but terminated early ‐ unknown when)
Outcomes Primary outcome(s): C‐peptide
Secondary outcome(s): HbA1c
Other outcome(s): adverse events
Relevant proposed outcome measures for SoF table: serious adverse events
Reason for awaiting classification Marked as terminated early ‐ the duration of the trial was not reported prior to termination
Study details Study identifier: NCT00564018; UTSW‐052006‐056
Study start date: September 2006
Study completion date: April 2011
Responsible party/principal investigator: Soumya Adhikari, University of Texas Southwestern Medical Center, USA
Official title and purpose of study Quote: "To determine whether using a long‐acting insulin analog at the time of diagnosis, instead of intermediate‐acting insulin, affects the rate of loss of the body's ability to make insulin in children with newly diagnosed type 1 diabetes."
Notes