Characteristic	Ashwell 2006	De Leeuw 2005	Francis 1986	Fulcher 2005	Hermansen 2001	Hermansen 2004	Home 2004	Home 2005	Kolendorf 2006
Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)	I1: Glargine + Lispro C1: NPH + HI	I1: Determir + Aspart C1: NPH + Aspart	I1: Ultralente + Porcine Insulin C1: NPH + Porcine Insulin	I1: Glargine + Lispro C1: NPH + Lispro	I1: Determir + HI C1: NPH + HI	I1: Determir + Aspart C1: NPH + HI	I1: Determir (Q12hr) + Aspart I2: Determir (breakfast+bedtime) + Aspart C1: NPH + Aspart	I1: Glargine + Hi C1: NPH + HI	I1: Determir + Aspart C1: NPH + Aspart
Randomised controlled clinical trial (RCT)	Y	Y	Y	Y	Y	Y	Y	Y	Y
Non‐inferiority / equivalence trial	Y	Y	Y	Y	Y	Y	Y	Y	Y
Controlled clinical trial	Y	Y	Y	Y	Y	Y	Y	Y	Y
Design: parallel, crossover, factorial RCT	Crossover	Parallel	Crossover	Parallel	Crossover	Parallel	Parallel	Parallel	Crossover
Crossover study: wash‐out phase	N		N		N				N
Crossover study: carryover effect tested	N		N		N				N
Method of randomisation	Central computer	?	?	?	?	?	Remote telephone	Central telephone	?
Unit of randomisation (individuals, cluster ‐ specify)	Individual	Individual	Individual	Individual	Clusters of 4	Individual	Individual	Individual	Individual
Randomisation stratified for centres	N	N	N	N	N	N	N	N	N
Randomisation ratio	1:1	2:1	1:1	1:1	1:1	1:1	1:1:1	1:1	1:1
Concealment of allocation	Y	?	?	?	?	?	?	?	?
Stated blinding (open; single, double, triple blind)	Open	Open	Open	Single blinding	Open	Open	Open	Open	Open
Actual blinding: participant	N	N	N	N	N	N	N	N	N
Actual blinding: caregiver / treatment administrator	N	N	N	Y	N	N	N	N	N
Actual blinding: outcome assessor	?	?	?	?	Y	?	?	?	?
Actual blinding: others	?	?	?	?	?	?	?	?	?
Blinding checked: participant	NA	NA	NA	NA	NA	NA	NA	NA	NA
Blinding checked: caregiver / treatment administrator	NA	NA	NA	?	NA	NA	NA	NA	NA
Primary endpoint defined	Y	N	N	Y	Y	Y	N	Y	Y
[n] of primary endpoint(s)	1	?	?	1	1	1	?	1	1
[n] of secondary endpoints	5	?	?	7	6	4	?	4	3
Total [n] of endpoints	6	5	14	8	7	5	6	5	4
Prior publication of study design	N	N	N	N	N	N	N	N	N
Outcomes of prior / current publication identical	NA	NA	NA	NA	NA	NA	NA	NA	NA
Power calculation	Y	Y	N	Y	Y	Y	Y	Y	Y
[n] participants per group calculated	54	?	NA	48	49	281 per group	366 total	?	132
Non‐inferiority trial: interval for equivalence specified	Y	Y	N	Y	Y	Y	Y	?	Y
Intention‐to‐treat analysis (ITT)	Y	Y	?	Y	?	Y	Y	?	?
ITT defined	Y	Y	N	Y	N	Y	Y	N	N
Analysis stratified for centres	N	N	N	N	N	N	N	N	N
Missing data: last‐observation‐carried‐forward (LOCF)	?	?	?	?	?	?	N	?	?
Missing data: other methods	?	?	?	?	?	?	?	?	?
LOCF defined	?	?	?	?	?	?	N	?	?
[n] of screened participants (I1/ I2 / C1 / total)	71	?	?	?	?	?	441 total	655 total	207 total
[n] treated with at least one dose (I1/I2/C1/Total)	56/56/56	217/99/316	6/6/6	62/63/125	59/59/59	298/297/595	137/139/132/408	292/293/585	127/130/130
[n] of participants finishing the study	51/51/51	212/96/308	6/6/6	58/49/107	56/56/56	289/286/575	135/132/124/391	276/272/548	124
[n] of patients analysed	54/54/54	217/99/316	6/6/6	62/63/125	56/56/56	298/297/595	137/139/132/408	292/293/585	125/127
Description of discontinuing participants	Y	Y	NA	Y	Y	Y	Y	Y	Y
Drop‐outs (reasons explained)	Y	Y	NA	Y	Y	Y	Y	Y	Y
Withdrawals (reasons explained)	Y	Y	NA	Y	Y	Y	Y	Y	Y
Losses‐to‐follow‐up (reasons explained)	Y	Y	NA	Y	Y	Y	Y	Y	Y
[n] of participants who discontinued	3/3/3	5/3/8	0/0/0	4/14/18	3 total	9/14/23	4/5/8/17	16/21/37	1/6/7
[%] discontinuation rate	5.5%	3%/3%	0%	6.4%/22.2%/14.4%	5% total	3%/5%	3%/4%/7%/	9% total	5.3% total
Discontinuation rate similar between groups	Y	Y	Y	N	Y	Y	Y	Y	Y
[%] crossover between groups	?	?	?	?	?	?	?	?	?
[n] of subgroups	0	0	0	0	0	0	0	2	0
Subgroups: pre‐defined	0	0	0	0	0	0	0	?	0
Subgroups: post‐hoc	0	0	0	0	0	0	0	?	0
Adjustment for multiple outcomes / repeated measurements	NA	NA	NA	NA	NA	NA	NA	NA	NA
Timing of outcomes' measurement comparable between groups	Y	Y	Y	Y	Y	Y	Y	Y	Y
Compliance measured	N	N	N	N	N	N	N	N	N
Other important covariates measured (specify)	N	N	N	N	N	N	N	N	N
Co‐morbidities measured	N	N	N	N	N	N	N	N	N
Co‐medications measured	N	N	N	N	N	N	N	N	N
Specific doubts about study quality	N	N	Y (very small study)	N	Y (no ITT)	N	N	N	N
Funding: commercial	Y	Y	N	Y	Y	Y	Y	Y	Y
Funding: non‐commercial	N	N	Y (novo laboratiries and British Diabetes Association)	N	N	N	N	N	N
Publication status: peer review journal	Y	Y	Y	Y	Y	Y	Y	Y	Y
Publication status: journal supplement	N	N	N	N	N	N	N	N	N
Publication status: abstract	N	N	N	N	N	N	N	N	N
Publication status: other	N	N	N	N	N	N	N	N	N
Single/multi‐center	Multi (5)	Multi (42)	Single	Multi (7)	Multi (7)	Multi (64)	Multi (52)	Multi (63)	Multi (11)
Countries	?	Europe	UK	Australia	?	Europe	Europe+Australia	Europe	Europe+Australia+South Africa
Diagnostic criteria for DM1 defined	N	N	N	N	N	N	N	N	N
Diagnostic criteria adequate	NA	NA	NA	NA	NA	NA	NA	NA	NA
Langauge of publication	English	English	English	English	English	English	English	English	English