title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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; HbA1c62.8 ± 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 HbA1cof 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.
  
  
  
  MEDIAS 2 BSC was more effective in lowering HbA1cthan 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).
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|Diabetes Centre Mergentheim, Bad Mergentheim, Germany.|Department of Clinical Psychology of the Otto Friedrich University Bamberg, Bamberg, Germany.
authors.forename: N
authors.identifier: 0000-0002-9610-0975
authors.initials: N
authors.lastname: Hermanns
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|Department of Clinical Psychology of the Otto Friedrich University Bamberg, Bamberg, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Ehrmann
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Schall
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|Diabetes Centre Mergentheim, Bad Mergentheim, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Maier
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|Diabetes Centre Mergentheim, Bad Mergentheim, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Haak
authors.affiliation: Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|Diabetes Centre Mergentheim, Bad Mergentheim, Germany.|Department of Clinical Psychology of the Otto Friedrich University Bamberg, Bamberg, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Kulzer
mesh_terms: D000368:Aged; D003131:Combined Modality Therapy / Q000009:adverse effects; D017281:Cost of Illness; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000628:therapy; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006442:Glycated Hemoglobin / Q000032:analysis; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010353:Patient Education as Topic; D011788:Quality of Life; D012307:Risk Factors; D057566:Self Report; D000073278:Self-Management / Q000193:education*; D012720:Severity of Illness Index
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human