Peyrot 2009.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 28 patients with type 1 diabetes, CSII‐naive, randomised 1:1 to insulin pump with integrated CGM or insulin pump + SMBG. 27 patients completed follow‐up INSULIN PUMP USERS: 0% SEX: 54% female AGE (mean age (SD)): 47.2 (13.2) ETHNIC GROUPS: 79% white DURATION OF DISEASE (mean years (SD)): 25.0 (12.6) INCLUSION CRITERIA: CSII‐naive adults with type 1 diabetes in suboptimal control (mean HbA1c 8.6%) EXCLUSION CRITERIA: n.a. 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: 2 COUNTRY: USA SETTING: outpatients CGM SYSTEM: Paradigm (Metronic Minimed) CONTROL: insulin pump + SMBG |
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| Outcomes |
PRIMARY: HbA1c SECONDARY:weight, reliability of measures, patient satisfaction 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 study examines the effects of the system on intermediate‐term glucose control and assesses patient‐reported outcomes (PRO) using a validated measure of treatment satisfaction and quality of life in addition to user acceptance measures for the components of the integrated system." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: Insufficient information. |
| Allocation concealment (selection bias) | Unclear risk | Comment: Insufficient information. |
| Blinding (performance bias and detection bias) Patient reported outcomes | Low risk | Comment: Not blinded, but not likely that the outcomes could be influenced. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Comment: Not blinded, but not likely that the HbA1c results could be influenced. |
| Incomplete outcome data (attrition bias) Short‐term outcomes | Low risk | Comment: Drop out rate: 1/28. One subject who started in the control arm dropped out of the study prior to completion. Not likely to influence results. |
| Selective reporting (reporting bias) | Low risk | Comment: No protocol available, but al mentioned outcomes in methods are reported in the results section. |
| Other bias | Low risk | |
| Inappropiate influence of sponsor prevented? | Low risk | "This study was funded by an unrestricted grant from Medtronic MiniMed Corp." |
| Free of conflicts of interest | Low risk | Comment: Competing interests, authors have received honorariums for speaking at research symposiums sponsored by manufacturers and research grant. However, many manufacturers are listed. |