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The effect of an education programme ( MEDIAS 2 BSC ) of non‐intensive insulin treatment regimens for people with Type 2 diabetes: a randomized, multi‐centre trial

2017; Wiley; Volume: 34; Issue: 8 Linguagem: Inglês

10.1111/dme.13346

1464-5491

Norbert Hermanns, Dominic Ehrmann, Sabine Schall, Björn Maier, T Haak, Bernhard Kulzer,

Diabetes Treatment and Management

Abstract Aims A self‐management oriented education programme ( MEDIAS 2 BSC ) for people with Type 2 diabetes who are on a non‐intensive insulin treatment regimen was developed. In a randomized, multi‐centre trial, the effect of MEDIAS 2 BSC was compared with an established education programme that acted as a control group. Methods The primary outcome was the impact of MEDIAS 2 BSC on glycaemic control. Secondary outcomes included the incidence of severe hypoglycaemia, hypoglycaemia unawareness, diabetes‐related distress, diabetes knowledge, quality of life and self‐care behaviour. Results In total, 182 participants were randomized to the control group or MEDIAS 2 BSC [median age 64.0 (interquartile range 58.0–68.5) vs. 63.5 (57.0–70.0) years; HbA 1c 62.8 ± 12.7 mmol/mol vs. 63.7 ± 14.0 mmol/mol; 7.9% ± 1.2% vs. 8.0% ± 1.3%]. After a 6‐month follow‐up, there was a mean decrease in HbA 1c of 3.5 mmol/mol (0.32%) in the control group and 6.7 mmol/mol (0.61%) in MEDIAS 2 BSC . After adjusting for baseline differences and study centre, the mean difference between the groups was −3.3 mmol/mol [95% confidence interval ( CI ) −0.54 to −5.90 mmol/mol] [−0.30% (95% CI −0.05 to −0.54)] in favour of MEDIAS 2 BSC ( P = 0.018). There were no increases in severe hypoglycaemia or hypoglycaemia unawareness. The education programmes had no significant effects on psychosocial outcome variables. Conclusion MEDIAS 2 BSC was more effective in lowering HbA 1c than the control condition. MEDIAS 2 BSC is a safe educational tool that improves glycaemic control without increasing the risk for hypoglycaemia. (Clinical Trials Registry No; NCT 02748239)