OBJECTIVE: In a randomized, multi-centre trial, the effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes was compared with an established education programme as an active comparator condition (ACC). METHODS: We investigated whether MEDIAS 2 ICT was non-inferior to ACC in overall glycaemic control. Secondary outcomes were the diabetes-related distress, diabetes knowledge, quality of life, self-care behavior, lipids, blood pressure and weight. RESULTS:186 subjects were randomized. After a six month follow-up the mean HbA1c decrease was 0.37% (from 8.2±1.1% to 7.8±1.5%) in the ACC and 0.63% (from 8.5±1.5% to 7.9±1.2%) in MEDIAS 2 ICT. The mean difference between both groups was -0.26% (95% CI -0.63 to -0.14) in favor of MEDIAS 2 ICT. This result was within the predefined limit for non-inferiority. Diabetes-related distress was significantly more reduced in MEDIAS 2 ICT (-3.4±7.1) than in ACC (0.4±9.0; p=0.31). CONCLUSION: MEDIAS 2 ICT is as effective in lowering HbA1c as previously established education programmes, but showed superiority in reducing diabetes-related distress. PRACTICAL IMPLICATIONS: MEDIAS 2 ICT provides an alternative for education of people with type 2 diabetes treated by multiple injection therapy.
RCT Entities:
OBJECTIVE: In a randomized, multi-centre trial, the effect of an education programme (MEDIAS 2 ICT) involving intensive insulin treatment for people with type 2 diabetes was compared with an established education programme as an active comparator condition (ACC). METHODS: We investigated whether MEDIAS 2 ICT was non-inferior to ACC in overall glycaemic control. Secondary outcomes were the diabetes-related distress, diabetes knowledge, quality of life, self-care behavior, lipids, blood pressure and weight. RESULTS: 186 subjects were randomized. After a six month follow-up the mean HbA1c decrease was 0.37% (from 8.2±1.1% to 7.8±1.5%) in the ACC and 0.63% (from 8.5±1.5% to 7.9±1.2%) in MEDIAS 2 ICT. The mean difference between both groups was -0.26% (95% CI -0.63 to -0.14) in favor of MEDIAS 2 ICT. This result was within the predefined limit for non-inferiority. Diabetes-related distress was significantly more reduced in MEDIAS 2 ICT (-3.4±7.1) than in ACC (0.4±9.0; p=0.31). CONCLUSION: MEDIAS 2 ICT is as effective in lowering HbA1c as previously established education programmes, but showed superiority in reducing diabetes-related distress. PRACTICAL IMPLICATIONS: MEDIAS 2 ICT provides an alternative for education of people with type 2 diabetes treated by multiple injection therapy.
Authors: S R Tittel; K M Sondern; M Weyer; T Poeplau; B M Sauer; M Schebek; K-H Ludwig; F Hammer; E Fröhlich-Reiterer; R W Holl Journal: Acta Diabetol Date: 2020-06-02 Impact factor: 4.280