Thunander 2010.

Methods	RANDOMISED CONTROLLED CLINICAL TRIAL (RCT): Patient preference randomised controlled trial (incomplete randomisation as patients refusing insulin were not analysed within the insulin arm as per ITT but were considered within the tablet arm). RANDOMISATION RATIO: randomised into two groups in blocks of eight NON‐INFERIORITY DESIGN: no EQUIVALENCE DESIGN: no ETHICS APPROVAL OBTAINED: yes PATIENT CONSENT OBTAINED: yes BLINDING OF PATIENT (P), EDUCATOR (E), RESEARCHER (R): P = no, E = no, R = no ANALYSIS BY INTENTION TO TREAT: reported to use intention to treat analysis but not evidence this was performed POWER CALCULATION: no
Participants	WHO PARTCIPATED: SEX (female% / male%): Conventional treatment group; 42% F (7/17), 58.8% M (10/17), insulin group 55% F(11/20), 45% M (9/20) AGE (mean years (SD)): Conventional treatment group = 57.8 ± 15.1, Insulin group = 51.0 ± 14.3 ETHNIC GROUPS (%): not stated DURATION OF DISEASE (median months (range)):Conventional treatment group = 5.0 [range 1 to 22], Insulin group = 6.0 [range: 1.5 to 24] INCLUSION CRITERIA: (1) diagnosis of diabetes (2) aged >30 yrs (3) not insulin requiring at diagnosis (3) GAD antibodies or ICA antibodies. EXCLUSION CRITERIA: (1) mental conditions or severe physical illness. DIAGNOSTIC CRITERIA: Diagnosed with diabetes with at least one of GADA or ICA CO‐MORBIDITIES:Not given CO‐MEDICATIONS: Not given NUMBER: Conventional treatment group 17, Insulin 20 LOSS TO FOLLOW‐UP:Conventional treatment group = 2 out of 17 lost at 36 months, Insulin group = 2 out of 20 lost at 36 months.
Interventions	NUMBER OF STUDY CENTRES:2 COUNTRY/ LOCATION: Sweden SETTING: out‐patient INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): subcutaneous insulin therapy starting with 2‐6 units intermediate‐acting insulin at night. CONTROL (ROUTE, TOTAL DOSE/DAY, FREQUENCY): diet +/‐ oral hypoglycaemic agents (metformin and or SU) TREATMENT BEFORE STUDY:None TITRATION PERIOD: None.
Outcomes	PRIMARY OUTCOME(S) (as stated in the publication):Not stated but objectives states "to investigate the effect of early insulin treatment of LADA patients on residual beta‐cell function compared to a group initially treated with diet and/or oral hypoglycaemic agents" SECONDARY OUTCOMES (as stated in the publication):Not stated but objectives states "to investigate the effect of early insulin treatment of LADA patients on metabolic control compared to a group initially treated with diet and/or oral hypoglycaemic agents" ADDITIONAL OUTCOMES: Collected at baseline and 12 months, 24 months and 36 months 1.HbA1c, 2. Glucagon‐stimulated C‐peptide and changes in C‐peptide were measured.
Study details	DURATION OF INTERVENTION:36 months DURATION OF FOLLOW‐UP: 36 months RUN‐IN PERIOD:None
Publication details	LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: no NON‐COMMERCIAL FUNDING: yes PUBLICATION STATUS (PEER REVIEW JOURNAL): yes PUBLICATION STATUS (JOURNAL SUPPLEMENT): no PUBLICATION STATUS (ABSTRACT): full paper
Stated aim for study	Quote "To investigate the effect of early insulin treatment of LADA patients, during three years, on residual beta‐cell function and metabolic control, compared to a group initially treated with diet and/or hypoglycaemic agents (OHA) "
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Low risk	Pre‐prepared envelopes were used which is a less robust method compared to phone or Internet allocation.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	There was no evidence that the analyst was blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	Intention to treat was reported but no evidence that it was used. i.e. last result carried forward for those lost to follow‐up, analysis within the insulin arm of those randomised to insulin but choosing to be treated with conventional medication.
Selective reporting (reporting bias)	Low risk	No problems identified
Other bias	Low risk	No problems identified