Cooke 2009.

Methods	PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL
Participants	All data given from the original publication, data from sub‐analysis provided by author are given where available. WHO PARTICIPATED: 404 patients (201 patients with type 1 diabetes) INSULIN PUMP USERS: 2% SEX: 221 males, 183 females AGE (median age (IQR)): 52 (41‐63) ETHNIC GROUPS: n.a. DURATION OF DISEASE (mean years (IQR)): 16 (10‐25) INCLUSION CRITERIA: 18 years or older, duration of diabetes > 6 months, >2 injections daily or CSII with poor diabetes control EXCLUSION CRITERIA: prior use of studied devices, pregnancy, planned surgery, dialysis treatment, haemoglobinopathies, inability to use study devices. DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: 3 times 72 hours during the first phase of the trial, then an additional 3 times during the second phase for the CGMS. For the glucowatch a minimum of 4 times per month during the first phase of the trial, then ad libitum during the second phase. DURATION OF FOLLOW‐UP: 18 months
Interventions	STUDY CENTRES: 4 COUNTRY: United Kingdom SETTING: outpatients CGM SYSTEM: CGMS (Metronic Minimed), Glucowatch CONTROL: SMBG both standard and attention control
Outcomes	PRIMARY: percentage change HbA1c from baseline to 18 months SECONDARY: HbA1c change at 3, 6 and 12 months, proportion of patients reaching 12.5% reduction in HbA1c levels. Glucose levels <3.5 mmol/L ADDITIONAL: distribution of hypoglycaemia, ease of use, confidence in use.
Study details	RUN‐IN PERIOD: no STUDY TERMINATED BEFORE REGULAR END: no
Publication details	LANGUAGE OF PUBLICATION: English NON‐COMMERCIAL FUNDING: National Institute for Health Research, Health Technology Assessment Programme PUBLICATION STATUS: Peer review journal
Stated aim of study	"Commencing in 2002, this trial was designed to address the limitations of previous studies by examining the impact on glycaemic control of two CGM devices that had received regulatory approval at that time [GlucoWatch G2 Biographer (Animas Corporation, West Chester, PA, USA) and the MiniMed continuous glucose monitoring system (CGMS; Medtronic, Northridge, CA, USA)]."
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization was concealed until the point of allocation and was carried out centrally by telephone. To reduce imbalance between groups, allocation was performed using minimization of three factors: centre, age and type of diabetes. The minimization algorithm contained a random element. Randomization was carried out centrally by telephone."
Allocation concealment (selection bias)	Low risk	"Randomization was concealed until the point of allocation and was carried out centrally by telephone. To reduce imbalance between groups, allocation was performed using minimization of three factors: centre, age and type of diabetes. The minimization algorithm contained a random element. Randomization was carried out centrally by telephone."
Blinding (performance bias and detection bias) Objective outcomes	Low risk	Comment: No blinding, but lack of blinding is unlikely to influence outcomes.
Incomplete outcome data (attrition bias) Short‐term outcomes	Low risk	Comment: Comparable drop‐out rates in all groups.
Incomplete outcome data (attrition bias) Long‐term outcomes	Low risk	Comment: Comparable drop‐out rates in all groups.
Selective reporting (reporting bias)	Low risk	Comment: All outcomes measures reported.
Other bias	Low risk	Comment: Groups comparable at baseline.
Inappropiate influence of sponsor prevented?	Low risk	Comment: Study funded by the National Institute for Health Research. Two different types of CGM systems.
Free of conflicts of interest	Unclear risk	Comment: Various authors have received honoraria from CGM manufacturers.