Lagarde 2006.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 27 children with type 1 diabetes, randomised to CGM (n=18) or SMBG (n=9). No dropouts. INSULIN PUMP USERS: 70% SEX: 15 females, 12 males AGE (mean age (SD)): 9.94 (3.2) in the CGM group, 14.22 (2.9) in the control group. ETHNIC GROUPS: 17 Caucasian and 1 African American in the CGM group, 9 Caucasian in the control group. DURATION OF DISEASE (mean years (SD)): 4.5 (2.5) years in the CGM group, 4.2 (2.1) years in the control group. INCLUSION CRITERIA: age 5‐17 years; a diagnosis of type 1 diabetes treated with insulin for 1 yr or more; availability for all study visits; and willingness to wear a medical device for 72 consecutive hours. EXCLUSION CRITERIA: history of acute metabolic decompensation such as diabetic ketoacidosis within 1 month of study enrolment; use of chronic medications known to affect glucose levels such as systemic corticosteroids; and pregnancy. DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: 72‐h periods at 0, 2, and 4 months DURATION OF FOLLOW‐UP: 4 months |
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| Interventions |
STUDY CENTRES: 1 COUNTRY: USA SETTING: outpatients CGM SYSTEM: CGMS (Metronic Minimed) CONTROL: blinded CGM |
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| Outcomes |
PRIMARY: HbA1c SECONDARY: mean daily area under the CGMS curve for glucose <70 mg/dL area under the curve (AUC<70), mean daily time <70 (MDT<70), daily area under the CGMS curve for glucose >180 mg/dL (AUC>180). 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 NON‐COMMERCIAL FUNDING: Agency for Health Care Research and Quality PUBLICATION STATUS: Peer review journal |
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| Stated aim of study | "The purpose of this study was to determine if the use of CGMS improves metabolic control in children with T1DM." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Participants were randomised 2:1 into an intervention group (CGMS data utilized) or control group (CGMS data blinded) using a computer‐ generated randomisation list created by a statistician." |
| Allocation concealment (selection bias) | Low risk | "Allocation was concealed from the investigators, and the participants were blinded to which study group they were assigned." |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Comment: HbA1c probably “Yes”. Other data from the devices “No” because they were used for review in the intervention group. |
| Incomplete outcome data (attrition bias) Short‐term outcomes | Unclear risk | Comment: All participants completed the study. |
| Incomplete outcome data (attrition bias) Long‐term outcomes | Low risk | |
| Selective reporting (reporting bias) | Low risk | Comment: All outcomes mentioned in the methods section, were reported. |
| Other bias | Unclear risk | Comment: Difference in baseline characteristics. Lower age in intervention group favours this group (see JDRF 2008a). |
| Inappropiate influence of sponsor prevented? | Unclear risk | Comment: Provision of study CGM devices by manufacturer. |
| Free of conflicts of interest | Unclear risk | Comment: Insufficient information. |