Juvenile 2008.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 322 patients with type 1 diabetes, in three age groups (n=CGM/ n=SMBG): 8‐14 years (56/58), 15‐25 years (57/53) and >25 years (52/46). 98% completed follow‐up. INSULIN PUMP USERS: 84% / 71% / 84% SEX: female: 49% / 61% / 58% AGE (mean age (SD)): 8‐14 years group: 11.4 (2.0) in the CGM group, 11.6 (2.1) in the control group. 15‐24 years group: 18.8 (3.0) for the CGM group, 18.2 (2.7) for the control group. >25 years group: 41.2 (11.2) for the CGM group, 44.6 (12.3) for the control group. ETHNIC GROUPS: 296 (92%) non‐Hispanic white race DURATION OF DISEASE (mean years (SD)): in the >25 years group: 23.6 (10.6) for the CGM group, 21.8 (10.4) for the control group. In the 15‐24 years group: 9.5 (4.8) for the CGM group, 8.8 (4.0) for the control group. In the 8‐14 years group: 6.2 (3.1) in the CGM group, 5.3 (2.8) in the control group. INCLUSION CRITERIA: 8 years of age or older, type 1 diabetes at least 1 year before randomisation, use an insulin pump or received at least three daily insulin injections, HbA1c level of 7.0 to 10.0%. EXCLUSION CRITERIA: use of CGM at home in the 6 months leading up to the trial. DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: 6 months DURATION OF FOLLOW‐UP: 6 months |
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| Interventions |
STUDY CENTRES: 10 COUNTRY: USA SETTING: outpatients CGM SYSTEM: Dexcom Seven (Dexcom), Paradigm Real‐Time Insulin Pump (Minimed Medtronic) and CGMs, Freestyle Navigator (Abbott) CONTROL: SMBG |
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| Outcomes |
PRIMARY: HbA1c SECONDARY: time spent in hypoglycaemia, euglycaemia and hyperglycaemia. glucose variability. hypoglycaemic events. ADDITIONAL: n.a. |
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| Study details |
RUN‐IN PERIOD: yes STUDY TERMINATED BEFORE REGULAR END: no |
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| Publication details |
LANGUAGE OF PUBLICATION: English NON‐COMMERCIAL FUNDING: Juvenile Diabetes Research Foundation PUBLICATION STATUS: Peer review journal |
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| Stated aim of study | "In this randomized, multicente, clinical trial, we evaluated the efficacy and safety of continuous glucose monitoring in adults and children with type 1 diabetes." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “Patients meeting these criteria were randomly assigned to receiving CGM or home monitoring with the use of a permuted block design.” Comment: Sequence generation process not described. |
| Allocation concealment (selection bias) | Unclear risk | Comment: Method to conceal allocation not described. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Comment: Outcomes: lab‐measurements. Study staff not blinded and patients partly blinded (the control group had blinded CGM at 13 and 26 weeks). Lack of blinding is not likely to introduce bias. |
| Incomplete outcome data (attrition bias) Short‐term outcomes | Low risk | Comment: Low drop‐out rates (<5%, Fig 1 supplementary appendix of article). |
| Incomplete outcome data (attrition bias) Long‐term outcomes | Low risk | Comment: Low drop‐out rates (<5%, Fig 1 supplementary appendix of article). |
| Selective reporting (reporting bias) | Low risk | Comment: All predefined outcomes are reported. |
| Other bias | Low risk | |
| Inappropiate influence of sponsor prevented? | Low risk | Comment: Many different manufactures and pharmaceutical companies are listed in the acknowledgements. Supported by grants from the Juvenile Diabetes Research Foundation. |
| Free of conflicts of interest | Low risk | Comment: Several authors received lecture fees and grant support from the CGM manufacturers. Bias is not likely since different manufacturers are involved in this study. |