Chantelau 1985.

Study characteristics
Methods	Study design: cross‐over randomised controlled trial
Participants	Inclusion criteria: type 1 diabetes mellitus C‐peptide negative (postabsorptive C‐peptide levels < 0.2 ng/mL) normal body weight (BMI < 25 kg/m²) on continuous subcutaneous insulin infusion therapy and "liberalized diet" for more than 1 year well‐controlled at the beginning of the study Exclusion criteria: — Diagnostic criteria: — Setting: outpatients Age group: adults Sex: females and males Country where trial was performed: Germany
Interventions	Intervention(s): sodium‐cyclamate 348 ± 270 mg/day Comparator(s): sucrose 24 ± 13 g/day Duration of intervention: 4 weeks Duration of follow‐up: 4 weeks Run‐in period: 4 weeks Number of study centres: 1
Outcomes	Reported outcomes in full text of publication: HbA1c, body weight, lipid profile (total‐C, HDL, TG), glucose levels (postprandial)
Identification	Trial identifier: — Trial terminated early: no
Publication details	Language of publication: English Funding: — Publication status: peer‐reviewed journal and full article
Stated aim for study	Quote from publication: "we have studied the metabolic effects of sucrose included in the diet of Type 1 diabetic outpatients treated with continuous subcutaneous insulin infusion"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "patients were assigned to use either sucrose or sodium‐cyclamate as sweetener in random order" Comment: based on information from the authors random sequence was generated by tossing a coin
Allocation concealment (selection bias)	High risk	Quote from publication: "They were then asked to change over to sodium‐cyclamate or sucrose, respectively, for another 4‐week period." Comment: based on information from the authors allocation to treatment groups was done "openly"
Blinding of participants and personnel (performance bias) body weight	High risk	Quote from publication: "During the sucrose‐period, sucrose and sucrose‐sweetened foods were allowed ad libidum." "During the cyclamate period, sodium cyclamate was allowed ad libidum within the limitations set up by the World Health Organisation." Comment: participants were not blinded; investigator‐assessed outcome measure
Blinding of participants and personnel (performance bias) glucose levels	High risk	Quote from publication: "During the sucrose‐period, sucrose and sucrose‐sweetened foods were allowed ad libidum." "During the cyclamate period, sodium cyclamate was allowed ad libidum within the limitations set up by the World Health Organisation." Comment: participants were not blinded; postprandial plasma glucose; investigator‐assessed outcome measure
Blinding of participants and personnel (performance bias) HbA1c	Low risk	Quote from publication: "During the sucrose‐period, sucrose and sucrose‐sweetened foods were allowed ad libidum." "During the cyclamate period, sodium cyclamate was allowed ad libidum within the limitations set up by the World Health Organisation." Comment: participants were not blinded; investigator‐assessed outcome measure; outcome unlikely to have been influenced by lack of blinding
Blinding of participants and personnel (performance bias) lipid profile	Low risk	Quote from publication: "During the sucrose‐period, sucrose and sucrose‐sweetened foods were allowed ad libidum." "During the cyclamate period, sodium cyclamate was allowed ad libidum within the limitations set up by the World Health Organisation." Comment: participants were not blinded; total cholesterol, HDL‐cholesterol, triglycerides were assessed by the investigators; outcome unlikely to have been influenced by lack of blinding
Blinding of outcome assessment (detection bias) body weight	Low risk	Comment: the publication does not address blinding of outcome assessors; based on information from the authors, body weight was measured independently by personnel unrelated to the study; exact equipment used for measurement; investigator‐assessed outcome measure
Blinding of outcome assessment (detection bias) glucose levels	Low risk	Comment: the outcome is unlikely to have been influenced by lack of blinding; investigator‐assessed outcome measure
Blinding of outcome assessment (detection bias) HbA1c	Low risk	Comment: the outcome is unlikely to have been influenced by lack of blinding; investigator‐assessed outcome measure
Blinding of outcome assessment (detection bias) lipid profile	Low risk	Comment: the outcome is unlikely to have been influenced by lack of blinding; investigator‐assessed outcome measure
Incomplete outcome data (attrition bias) anthropometric measures other than body weight	Low risk	Quote from publication: "Ten Type 1 diabetic subjects, eight women and two men (...) volunteered to participate in the study" Comment: data available for all included participants
Incomplete outcome data (attrition bias) glucose levels	Low risk	Quote from publication: "Ten Type 1 diabetic subjects, eight women and two men (...) volunteered to participate in the study" Comment: data available for all included participants
Incomplete outcome data (attrition bias) HbA1c	Low risk	Quote from publication: "Ten Type 1 diabetic subjects, eight women and two men (...) volunteered to participate in the study" Comment: data available for all included participants
Incomplete outcome data (attrition bias) lipid profile	Low risk	Quote from publication: "Ten Type 1 diabetic subjects, eight women and two men (...) volunteered to participate in the study" Comment: data available for all included participants
Selective reporting (reporting bias)	Low risk	Comment: low risk of bias according to ORBIT
Other bias	Unclear risk	Comment: cross‐over design without washout period between interventions