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. 2021 Mar 4;2021(3):CD013498. doi: 10.1002/14651858.CD013498.pub2
Study ID Review's primary and secondary outcomes Timing of outcome measurement in study
Bartley 2008 Hypoglycaemia and safety data At each visit (baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 104 weeks)a
HbA1c Baseline, 12 weeks, 24 weeks, 36 weeks, 52 weeks, 64 weeks, 76 weeks, 88 weeks, 104 weeksa
BEGIN Basal‐Bolus Type 1 Hypoglycaemia and safety data Baseline, every second week during study (main study) (for extension study every 4th week)a
HbA1c Baseline, 12 weeks, 16 weeks, 26 weeks
BEGIN Flex T1 Hypoglycaemia and safety Baseline, every second week during study
HbA1c Baseline, 12 weeks, 16 weeks, 26 weeks
BEGIN Young Hypoglycaemia and safety Every visit (i.e. every third week during study)
HbA1c Baseline, 12 weeks, 16 weeks, 38 weeks, 52 weeks
Bolli 2009 Quality of life Baseline, 12 weeks, 24 weeks
HbA1c Baseline, 8 weeks, 16 weeks, 24 weeks
Safety At each visit (number of visits not described)
Chase 2008 Quality of life Baseline, 2 weeks, 6 weeks, 12 weeks, 18 weeks, 24 weeksa
HbA1c and hypoglycaemia During clinical visits at 6 weeks, 12 weeks, 18 weeks, 24 weeks
Adverse events Every 1 week of follow‐up
Davies 2014 Quality of life Baseline, 12 weeks, 26 weeks
Adverse events and hypoglycaemia Baseline, 1 week, 2 weeks and thereafter every second week
HbA1c Baseline, 12 weeks, 16 weeks, 26 weeks
Fulcher 2005a
 
Quality of life Baseline, 14 weeks, 30 weeks
Adverse events 6 weeks, 12 weeks, 18 weeks, 14 weeks, 30 weeks
HbA1c 6 weeks, 14 weeks, 22 weeks, 30 weeks
Hypoglycaemia 6 weeks, 12 weeks, 18 weeks, 14 weeks, 30 weeks
Economic data 14 weeks, 30 weeks
Heller 2009 Hypoglycaemic and adverse events Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 18 weeks, 24 weeks, 50 weeks, 36 weeks, 44 weeks, 52 weeks
HbA1c Baseline, 12 weeks, 24 weeks, 36 weeks, 52 weeks
Home 2005 Quality of life Baseline, 8 weeks, 20 weeks, 28 weeks
Hypoglycaemia, adverse events, HbA1c Baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 20 weeks, 28 weeks
Kobayashi 2007 Hypoglycaemia, adverse events, HbA1c Baseline, 48 weeks
Liu 2016 HbA1c Baseline, 12 weeks, 24 weeks
Hypoglycaemia, safety Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 25 weeksa
NCT00595374 Mortality, adverse events
NCT00605137 Hypoglycaemia, adverse events Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks, 18 weeks, 20 weeks, 22 weeks, 24 weeks
HbA1c Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
Pieber 2007 Hypoglycaemia and adverse events Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 8 weeks, 14 weeks, 20 weeks, 26 weeks
HbA1c Baseline, 20 weeks, 26 weeks
Porcellati 2004 Hypoglycaemia
HbA1c Not reported, but based on figure 2 in main publication, then every second month (0, 2, 4, 6, 8, 10, 12 months)
PRESCHOOL Adverse events, hypoglycaemia Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 26 weeks
HbA1c Baseline, 12 weeks, 24 weeks
Ratner 2000 Hypoglycaemia and adverse events Baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 20 weeks, 28 weeksa
Quality of life Baseline, 8 weeks, 20 weeks, 28 weeksa
Pharmacoeconomic assessment Baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 20 weeks, 28 weeksa
HbA1c Baseline, 8 weeks, 20 weeks, 28 weeks
Robertson 2007a Hypoglycaemia and safety Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 10 weeks, 18 weeks, 26 weeks
HbA1c Baseline, 18 weeks, 24 weeks
Russell‐Jones 2004 Hypoglycaemia and adverse events Baseline, 2 weeks, 4 weeks, 9 weeks, 13 weeks, 19 weeks, 26 weeks
HbA1c Baseline, 3 months, 6 months
Schober 2002 Hypoglycaemia and adverse events Baseline, 4 weeks, 16 weeks, 28 weeks
HbA1c Baseline, 4 weeks, 16 weeks, 28 weeks
Standl 2004 Quality of life Baseline, 13 weeks, 26 weeks
Safety and hypoglycaemia Baseline, 3 months, 6 months (extension: 9 months, 12 months)
HbA1c Baseline, 3 months, 6 months (extension: 9 months, 12 months)
SWITCH 1 Quality of life Baseline, 32 weeks
Hypoglycaemia/adverse events Weekly during study period
HbA1c Baseline, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks
Thalange 2013 Adverse events, hypoglycaemia Collected during the study
HbA1c Baseline, 12 weeks, 24 weeks, 38 weeks, 52 weeks
Urakami 2017 HbA1c and hypoglycaemia Baseline, 4 weeks, 12 weeks, 24 weeks
Vague 2003a Hypoglycaemia, safety Baseline, 2 weeks, 4 weeks, 9 weeks, 13 weeks, 19 weeks, 26 weeks, 27 weeks
HbA1c Baseline, 13 weeks, 26 weeks
—: denotes not reported
aInformation retrieved from clinical study report.
HbA1c: glycosylated haemoglobin A1c.