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

Autor: Thomas Haak, Norbert Hermanns, Sabine Schall, Berthold Maier, Bernhard Kulzer, Dominic Ehrmann
Rok vydání: 2017
Předmět:
Male
Health Knowledge
Attitudes
Practice
medicine.medical_specialty
Endocrinology
Diabetes and Metabolism
030209 endocrinology & metabolism
Type 2 diabetes
Severity of Illness Index
law.invention
03 medical and health sciences
0302 clinical medicine
Endocrinology
Cost of Illness
Patient Education as Topic
Quality of life
Randomized controlled trial
Risk Factors
Interquartile range
law
Germany
Internal medicine
Diabetes mellitus
Severity of illness
Internal Medicine
Humans
Hypoglycemic Agents
Insulin
Medicine
030212 general & internal medicine
Aged
Glycated Hemoglobin
Dose-Response Relationship
Drug
business.industry
Incidence
Self-Management
Middle Aged
medicine.disease
Combined Modality Therapy
Hypoglycemia
Confidence interval
Clinical trial
Diabetes Mellitus
Type 2
Hyperglycemia
Quality of Life
Physical therapy
Patient Compliance
Self Report
business
Follow-Up Studies
Zdroj: Diabetic Medicine. 34:1084-1091
ISSN: 0742-3071
DOI: 10.1111/dme.13346
Popis: 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)
Databáze: OpenAIRE
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