O'Connell 2009.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 62 patients with type 1 diabetes on CSII, randomised 1:1. 54 patients completed follow‐up INSULIN PUMP USERS: 100% SEX: 29% males in each group AGE (mean age (SD)): 23.4 (8.6) in the CGM group, 23.0 (8.1) in the control group. ETHNIC GROUPS: n.a. DURATION OF DISEASE (mean years (SD)): 11.1 (7.6) in the CGM group, 9.2 (7.2) in the control group. INCLUSION CRITERIA: age 13.0‐40.0 years, type 1 diabetes for >1 year, use of insulin pump therapy including proficiency with use of a bolus‐dose calculator for >3 months, HbA1c under or equal to 8.5%, reliably performing self‐monitoring of blood glucose (SMBG) at least four times daily, and internet access. Willingness to use the subcutaneous sensor component of the system for at least 70% of the total 3 month study period was a further protocol requirement. EXCLUSION CRITERIA: co‐existent medical problems that would interfere with their ability to use the system (e.g. impaired vision), co‐existent illness that otherwise predisposes to hypoglycaemia (e.g. adrenal insufficiency) or a history of severe hypoglycaemia while using insulin pump therapy DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: 3 months DURATION OF FOLLOW UP: 3 months |
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| Interventions |
STUDY CENTRES: 5 COUNTRY: Australia SETTING: outpatients CGM SYSTEM: Paradigm (Metronic Minimed) CONTROL: SMBG |
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| Outcomes |
PRIMARY: difference in the proportion of time in the target glycaemic range during the 3 month study period (derived from CGM, target range 4?10 mmol/l) SECONDARY:HbA1c, time in hypoglycaemic ( below or equal to 3.9 mmol/l) and hyperglycaemic (above or equal to 10.1 mmol/l) ranges and glycaemic variability. ADDITIONAL: n.a. |
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| Study details |
RUN‐IN PERIOD: no STUDY TERMINATED BEFORE REGULAR END: no |
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| Publication details |
LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: Medtronic inc PUBLICATION STATUS: Peer review journal |
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| Stated aim of study | "The aim of this study, therefore, was to assess the impact of patientled use of sensor‐guided pump management on indices of glycaemic control in adolescents and young adults with type 1 diabetes and compare the impact with that of standard insulin pump therapy." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Once recruited, a pair of participants was entered, in order of study number, into a computer generated schedule which randomly assigned each of the pair to one of the two study groups. The randomisation schedule was administered centrally; clinicians involved in participant recruitment had no access to the schedule." |
| Allocation concealment (selection bias) | Low risk | "Once recruited, a pair of participants was entered, in order of study number, into a computer generated schedule which randomly assigned each of the pair to one of the two study groups. The randomisation schedule was administered centrally; clinicians involved in participant recruitment had no access to the schedule." |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | "All HbA1c measurements were performed at a central independent DCCT‐accredited laboratory." |
| Incomplete outcome data (attrition bias) Short‐term outcomes | Unclear risk | Comment: Higher drop out rate in intervention group (17% versus 7%), most reasons for dropping out were related to wearing the CGM device. |
| Selective reporting (reporting bias) | Low risk | Comment: All predefined outcomes were reported and addressed. |
| Other bias | Low risk | |
| Inappropiate influence of sponsor prevented? | Unclear risk | Comment: This investigator‐initiated study was supported by Medtronic Australasia. |
| Free of conflicts of interest | Unclear risk | Comment: Several authors have received travel or research support by manufacturer. |