IRCT201203079224N1.

Methods	Allocation: randomised Intervention model: parallel‐group assignment Masking: open‐label Primary purpose: treatment
Participants	Condition: T1DM Estimated number of participants: 40 Inclusion criteria: age 6 to 11 years; T1DM under treatment of insulin at least 6 months; BMI below the 90th percentile at baseline and having the desire and ability to measure blood glucose self‐monitoring using glucometer devices Exclusion criteria: mental and physical disorders; patients who did not complete the study period and patients with diabetes who were not suitable for regular tracking and checking
Interventions	Intervention(s): glargine Comparator(s): NPH Duration of the intervention: 6 months
Outcomes	Primary outcome(s): fasting blood glucose, HbA1c, lipid profile Secondary outcome(s): — Other outcome(s): — Relevant proposed outcome measures for SoF table: none
Reason for awaiting classification	Marked as 'completed' in Clinicaltrials.gov but no publication available
Study details	Study identifier: IRCT201203079224N1 Study start date: May 2012 Study completion date: not reported, but marked as complete Responsible party/principal investigator: Dr. Aria Setoodeh, Tehran University of Medical Sciences
Official title and purpose of study	Insulin glargine + insulin aspart vs NPH insulin + regular insulin for people with type 1 diabetes
Notes	Primary investigator contacted. No reply