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. |