| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| Subgroup 2.6.1 Adults |
| Fulcher 2005 |
Low risk of bias |
The randomisation schedule for treatment assignments was prepared by centre on a 1:1 basis. A randomisation list was provided to each centre (pharmacy department or appropriate study personal but not to investigator blinded to the study). There were no relevant baseline imbalances. |
Low risk of bias |
Single‐blind trial design: the investigator responsible for insulin dosage adjustment was blinded to the treatment allocated to the participant and was not involved in any aspect relating to study supplies. The study coordinator and the participant were aware of the treatment allocation. The primary efficacy analysis was carried out with a modified intention‐to‐treat population (ITT), which consisted of all randomised patients with at least one dose of study medication. All secondary efficacy variables were also analysed on an ITT basis. |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. The primary efficacy analysis was carried out with a modified intention‐to‐treat population (ITT), which consisted of all randomised patients with at least one dose of study medication. All secondary efficacy variables were also analysed on an ITT basis. The safety population consisted of all randomised participants who received at least one dose of study medication. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Home 2005 |
Low risk of bias |
A 1:1 randomisation schedule was generated by the sponsor. This schedule paired sequential numbers with treatment codes allocated at random. The schedule was prepared by centre on a 1:1 basis. An independent agency was used for central telephone randomisation. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (participants with at least one measurement after baseline). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (efficacy was analysed using those intention‐to‐treat (ITT) participants for whom both a pre‐treatment and an on‐treatment value were available, with the exception of hypoglycaemia, for which the entire ITT population was analysed). |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Porcellati 2004 |
Low risk of bias |
A simple randomisation was used based on computer‐generated random numbers by a person who was not involved in establishing eligibility and entry of patients. Concealment of the randomisation was insured by having the allocation codes in a locked unreadable computer file handled by a person not involved in the recruitment of patients. The randomisation schedule was restricted and stratified by centre. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. All participants randomised finished the study. |
Low risk of bias |
All randomised participants completed the study. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Some concerns |
Scarce information on analysis plan. Only one measurement and result provided for the time point selected by review authors. |
Some concerns |
Open‐label trial design. Scarce information on analysis plan. |
| Ratner 2000 |
Low risk of bias |
The randomisation schedule was stratified according to centre and pre‐randomisation basal insulin regimen of once versus twice daily. Forty randomisation numbers were allocated to each basal insulin regimen for each centre. To ensure a balanced number of participants for each treatment group the randomisation schedule was generated using block sizes of 4. An independent agency was used for central telephone randomisation. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all randomised participants exposed to at least one dose of trial product). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (all exposed participants were analysed). Missing observations were considered missing at random in all analyses. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Subgroup 2.6.2 Children |
| Chase 2008 |
Low risk of bias |
Two randomisation schedules with a 1:1 randomisation ratio, one for males another for females, were generated by the sponsor. At the point of randomisation both the investigator/study coordinator and the participant were blinded to the treatment allocation (to randomisation). The randomisation schedule was stored with the randomisation code administrator at Aventis Pharmaceuticals, Bridgewater, NJ. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. Modified intention‐to‐treat analysis set was used (participants taking at least one dose of study medication with a baseline measurement and at least one follow‐up measure; the safety population consisted of all randomised participants who received at least one dose of study medication). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (participants taking at least one dose of study medication with a baseline measurement and at least one follow‐up measure; the safety population consisted of all randomised participants who received at least one dose of study medication). |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Liu 2016 |
Low risk of bias |
For efficacy analyses, patients were analysed in the treatment group allocated by the Interactive Voice Response System/Interactive Web Response System (IVRS/IWRS) at randomisation (as randomised). There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all randomised participants who received at least one dose, and had both a baseline assessment and at least one post‐baseline assessment for at least one efficacy variable). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. The efficacy analyses were based on the modified intention‐to‐treat (mITT) population, corresponding to all randomised patients who received at least one dose, and had both a baseline assessment and at least one post‐baseline assessment for at least one efficacy variable. The safety population was defined as all randomised patients who took at least one dose or partial dose. In the event of patients having received treatments that differed from those assigned according to the randomisation schedule, then the safety analyses were to be conducted according to the treatment received rather than according to the randomisation groups. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| PRESCHOOL |
Low risk of bias |
Participants were centrally randomised (utilising permuted block randomisation schedule) via Interactive Voice Response System (IVRS) at a 1:1 ratio to one of the two treatment groups. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (all randomised participants exposed to at least one dose of trial product). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. The efficacy population consisted of all randomised patients who received at least one dose of the study medication (modified intent‐to‐treat [mITT] population). |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
| Schober 2002 |
Low risk of bias |
A 1:1 randomisation schedule was generated by the sponsor. This schedule paired sequential numbers with treatment codes allocated at random. The schedule was prepared by centre on a 1:1 basis. An independent agency was used for central telephone randomisation. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. The modified intention‐to‐treat (ITT) population was defined as all participants randomised and treated. |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. The modified intention‐to‐treat (ITT) population was defined as all participants randomised and treated. The safety population compromised all participants who were randomised and received study medication. Efficacy was analysed using those ITT participants for whom both a pre‐treatment and an on‐treatment value were available. |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
