Yates 2006.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 36 patients with type 1 diabetes, 19 in the CGM group and 17 in the control group. No dropouts. INSULIN PUMP USERS: 47% SEX: 7 (37%) males in the CGM group, 6 (36%) males in the control group. AGE (mean age (range)): 14.7 (13.6‐14.4) years in the CGM group, 14.1 (12.8‐15.3) in the control group. ETHNIC GROUPS: n.a. DURATION OF DISEASE (mean years (SD)): n.a. INCLUSION CRITERIA: age 18 years or less, type 1 diabetes for at least 1 year; use of CSII or an MDI regimen that included glargine for at least 3 months. EXCLUSION CRITERIA: known poor compliance or A1C >10%. DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: 3 months, 72 hours of CGM use every 3 weeks DURATION OF FOLLOW‐UP: 6 months |
|
| Interventions |
STUDY CENTRES: 1 COUNTRY: Australia SETTING: outpatients CGM SYSTEM: CGMS (Medtronic Minimed) CONTROL: SMBG |
|
| Outcomes |
PRIMARY: HbA1c SECONDARY: adverse events, AUC, hypoglycaemia ADDITIONAL: n.a. |
|
| Study details |
RUN‐IN PERIOD: no STUDY TERMINATED BEFORE REGULAR END: no |
|
| Publication details |
LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: Medtronic Inc PUBLICATION STATUS: Peer review journal |
|
| Stated aim of study | "The purpose of this study was to assess the effect on diabetes control of guiding insulin adjustment with four cycles of CGMS over 3 months in children on near physiological insulin replacement regimen." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was done by an independent body using biased coin randomisation." |
| Allocation concealment (selection bias) | Low risk | "Group allocation was blinded with opaque sealed envelopes." |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Comment: Not blinded, but lack of blinding is unlikely to influence the results. Patients were not asked to adhere to a special diet or exercise routine but were encouraged to continue their usual behaviour. |
| Incomplete outcome data (attrition bias) Short‐term outcomes | Low risk | Comment: No drop outs (n=19 vs n=17), see Figure 1. |
| Incomplete outcome data (attrition bias) Long‐term outcomes | Low risk | Comment: No drop outs (n=19 vs n=17), see Figure 1. |
| Selective reporting (reporting bias) | Low risk | Comment: The study protocol is not publicly available, but the published report includes all the pre‐specified outcomes. |
| Other bias | Low risk | |
| Inappropiate influence of sponsor prevented? | Low risk | Comment: Statement of ‘unrestricted funding’. |
| Free of conflicts of interest | Unclear risk | Comment: K.Y. and G.A. have received grant/research support from Medtronic MiniMed. |