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

Faculty/Professorship: Clinical Psychology and Psychotherapy  ; Pathopsychology  
Author(s): Hermanns, Norbert  ; Ehrmann, Dominic  ; Schall, S; Maier, Berthold ; Haak, Thomas; Kulzer, Bernhard
Title of the Journal: Diabetic Medicine
ISSN: 1464-5491
Publisher Information: Oxford [u.a.] : Wiley-Blackwell
Year of publication: 2017
Volume: 34
Issue: 8
Pages: 1084-1091
Language(s): English
DOI: 10.1111/dme.13346
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; HbA1c 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 HbA1c 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 HbA1c 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).
Peer Reviewed: Ja
International Distribution: Ja
Type: Article
Year of publication: 22. June 2018