Kordonouri 2010.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 160 patients with type 1 diabetes SEX: 80 females, 74 males AGE (mean age (SD)): 8.5 (4.6) in the CGM group, 9.1 (4.2) in the control group. ETHNIC GROUPS: n.a. DURATION OF DISEASE (mean years (SD)): study started immediately after diagnosis INCLUSION CRITERIA: diagnosed with type 1 diabetes within 4 weeks of inclusion date, aged 1 through 16 years EXCLUSION CRITERIA: n.a. DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: 52 weeks DURATION OF FOLLOW‐UP: 52 weeks |
|
| Interventions |
STUDY CENTRES: 5 centres COUNTRY: Pan‐European SETTING: outpatients CGM SYSTEM: Medtronic Paradigm CONTROL: SMBG with CSII TREATMENT BEFORE STUDY: none |
|
| Outcomes |
PRIMARY: HbA1c after 12 months SECONDARY: fasting C‐peptide, glycaemic variability, sensor usage, adverse events, children's health‐related quality of life and parent's well being. 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 | "To assess the acceptance, efficacy and safety of the use of CGM in combination with insulin pump therapy from the diagnosis of type 1 diabetes in children and adolescents. Particularly, we set out to determine whether the use of sensor‐augmented insulin pump therapy leads to better glycaemic control, lower daily insulin requirements, higher residual beta cell function, lower incidence of severe hypoglycaemia and better quality of life after 1 year of treatment compared with the use of a conventional insulin pump combined with conventional self‐monitoring of blood glucose." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were assigned by a central randomisation procedure." |
| Allocation concealment (selection bias) | Unclear risk | "Patients were assigned by a central randomisation procedure." |
| Blinding (performance bias and detection bias) Patient reported outcomes | Low risk | Comment: Patients and staff not blinded. Lack of blinding is not likely to introduce bias. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Comment: Patients and staff not blinded. Lack of blinding is not likely to introduce bias. |
| Incomplete outcome data (attrition bias) Long‐term outcomes | Low risk | Comment: Low drop‐out rates (4/80 in the CGM group and 2/80 in the SMBG group), reasons provided. |
| Selective reporting (reporting bias) | Unclear risk | Comment: Weight and occurrence of hypoglycaemia below 70 mg/dl (3.9 mmol/l) during 24 hour expressed as AUC below 70 mg/dl (3.9 mmol/l) and occurrence of hyperglycaemia above 200 mg/dl (11.1 mmol/l) during 24 hours expressed as AUC were mentioned in the protocol, but not listed or reported in the article. |
| Other bias | Low risk | Comment: No baseline imbalances. |
| Inappropiate influence of sponsor prevented? | Unclear risk | Comment: Funding by Medtronic, no further details. |
| Free of conflicts of interest | Unclear risk | Comment: Investigator‐initiated trial, supported by Medtronic. Several authors received honoraria, consulting fees and travel reimbursement from Medtronic. |