Tanenberg 2004.
| Methods | PARALLEL RANDOMISED CONTROLLED CLINICAL TRIAL | |
| Participants |
WHO PARTICIPATED: 128 patients with insulin treated diabetes, randomised to CGM (n=62) or SMBG (n=66). 19 patients dropped out; 4 had missing HbA1c values. INSULIN PUMP USERS: 46% SEX: 19 males, 32 females in the CGM group, 25 males, 33 females in the control group. AGE (mean age (SD)): 44.0 (10.2) in the CGM group, 44.5 (12.6) in the control group ETHNIC GROUPS: 44 whites, 7 other in the CGM group. 48 white, 10 other in the control group. DURATION OF DISEASE (mean years (SD)): 20.4 (10.7) in the CGM group, 19.5 (11.9) in the control group INCLUSION CRITERIA: insulin treated diabetes, age 17‐76 years, Hba1c >7.9% EXCLUSION CRITERIA: n.a. DIAGNOSTIC CRITERIA: n.a. CO‐MORBIDITIES: n.a. CO‐MEDICATION: n.a. DURATION OF INTERVENTION: 2 periods of 3 days (week 1 and week 3) DURATION OF FOLLOW‐UP: 3 months |
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| Interventions |
STUDY CENTRES: 7 COUNTRY: USA SETTING: outpatients CGM SYSTEM: CGMS (Metronic Minimed) CONTROL: SMBG |
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| Outcomes |
PRIMARY: HbA1c SECONDARY: sensor performance, hypoglycaemia 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 purpose of this study was to show improved glycemic control in patients with insulin‐treated diabetes after adjustments to the diabetes management plan based on either continuous glucose monitoring using the CGMS or frequent SMBG using a home blood glucose meter." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | “A random number list, computer generated by Medtronic Minimed with SAS statistical software was used.” |
| Allocation concealment (selection bias) | Low risk | "Random assignments to the treatment or control group were provided to the study centers in sealed envelopes." |
| Blinding (performance bias and detection bias) Objective outcomes | Low risk | Comment: Lack of blinding is not likely to introduce bias. |
| Incomplete outcome data (attrition bias) Short‐term outcomes | Unclear risk | Comment: Dropout rate 18% (11/62) in CGM versus 12% (8/66) in control group (fig 1). “In each group 14 patients had incomplete end‐of‐study downloads (failure of centre to transmit data).” |
| Selective reporting (reporting bias) | Low risk | Comment: All predefined outcomes were reported, except for adverse reactions. |
| Other bias | Low risk | |
| Inappropiate influence of sponsor prevented? | Unclear risk | “This study is sponsored by Medtronic Minimed.” |
| Free of conflicts of interest | Unclear risk | Comment: Two authors have received funds from Medtronic, of which one is also a member of the medical board. Two authors are employees of Medtronic. |