Hermanides 2011.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 83 adults, randomised to 44 in the CGM group and 39 in the control group. 78 patients completed the study INSULIN PUMP USERS: 0% SEX: CGM group 78% males, control 82% males AGE (mean years (SD)): CGM group 39.3 (11.9), control 37.3 (10.7) ETHNIC GROUPS: n.a. DURATION OF DISEASE (mean years (SD)): CGM group 16.9 (10.7), control 21.0 (9.4) INCLUSION CRITERIA: age 18‐65 years, type 1 diabetes at least one year, Hba1c ≥8.2% despite efforts to improve by re‐education, including insulin pump therapy availability. EXCLUSION CRITERIA: hearing or vision impairment or other chronic illnesses, pump treatment in the last 6 months. DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: continuous (6 months) DURATION OF FOLLOW‐UP: 6 months |
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| Interventions |
STUDY CENTRES: 8 COUNTRY: Denmark, Switzerland, The Netherlands, Sweden, France, United Kingdom, Belgium, Italy. SETTING: outpatients CGM SYSTEM: Paradigm sensor‐augmented pump therapy (Medtronic Minimed) continuous CONTROL: SMBG with 2 times 6 day blinded CGM measurement without subsequent treatment advice. |
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| Outcomes |
PRIMARY: HbA1c SECONDARY: CGM derived time spent in hyperglycaemia and hypoglycaemia. Number of hypo‐ and hyperglycaemic events per day. Sensor use. Proportion of patients reaching HbA1c <7%, contact time with study personnel, number of SMBG measurements per 3 weeks, insulin dose. ADDITIONAL: Questionnaires: Health‐related quality of life was assessed using the 36‐item Short Form version 2. The Problem Areas in Diabetes Scale is a 20‐item questionnaire that scores diabetes‐related physiological distress. The Diabetes Treatment Satisfaction Questionnaire comprises six items and is scored on a 0–36 scale, with higher scores indicating higher satisfaction.The 13‐item worry subscale of the Hypoglycaemia Fear Survey was administered. The Hypoglycaemia Fear Survey and the Problem Areas in Diabetes Scale could not be administered in all centres, because of lack of validated translations. |
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| Study details |
RUN‐IN PERIOD: 6 days STUDY TERMINATED BEFORE REGULAR END: no |
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| Publication details |
LANGUAGE OF PUBLICATION: English COMMERCIAL FUNDING: Medtronic PUBLICATION STATUS: Peer review journal |
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| Stated aim of study | "Therefore, we compared sensor‐augmented pump therapy to intensive multiple daily injection therapy in patients with suboptimally controlled Type 1 diabetes mellitus in a randomized controlled multi‐centre trial." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was stratified per centre in computer‐generated sequences unknown to the investigator. Via a secured Internet database (Oracle Corporation, Redwood City, CA, USA), the investigators performed the randomization. Computer generated sequences were used." |
| Allocation concealment (selection bias) | Low risk | "Randomization was stratified per centre in computer‐generated sequences unknown to the investigator. Via a secured Internet database (Oracle Corporation, Redwood City, CA, USA), the investigators performed the randomization. Computer generated sequences were used." |
| Blinding (performance bias and detection bias) Patient reported outcomes | Low risk | Comment: Unable to blind due to nature of intervention, however lack of blinding is unlikely to influence objective outcomes. |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Comment: Unable to blind due to nature of intervention, however lack of blinding is unlikely to influence objective outcomes. |
| Incomplete outcome data (attrition bias) Long‐term outcomes | Low risk | "The trial was completed by 43/44 (98%) patients in the sensor‐augmented insulin pump group and 35/39 (90%) patients in the multiple daily injections group." |
| Selective reporting (reporting bias) | Low risk | Comment: All outcome measures reported. |
| Other bias | Low risk | Comment: Groups comparable at baseline. |
| Inappropiate influence of sponsor prevented? | Low risk | "The funding source had an advising role in trial design details and drafting of the report and was only involved in the collection of the sensor data. The funding source had no role in the conduct of the analyses, interpretation of the data or in the decision to approve publication." |
| Free of conflicts of interest | Unclear risk | Comment: Two authors received fees from Medtronic. |