title: Flexible guided self-determination intervention for younger adults with poorly controlled Type 1 diabetes, decreased HbA1c and psychosocial distress in women but not in men: a real-life RCT.
abstract: OBJECTIVE
  To report results from an 18-month randomized controlled trial (RCT) testing the effectiveness of a flexible guided self-determination (GSD) intervention on glycaemic control and psychosocial distress in younger adults with poorly controlled Type 1 diabetes.
  
  
  METHODS
  Between January 2010 and February 2012, we randomly allocated two hundred 18-35-year-olds [mean age 25.7 (5.1) years, 50% men] with Type 1 diabetes for ≥ 1 year [mean duration 13.7 (6.8) years] and HbA1c  ≥ 64 mmol/mol (8.0%) to either an immediate GSD (intervention; n = 134) or 18-months delayed GSD group (control; n = 66). Group-based or individual GSD sessions were offered, drawing on reflection sheets and advanced professional communication. The primary outcome was HbA1c (measured at baseline and every three months thereafter) and among secondary outcomes was psychosocial distress (self-reported at baseline and after nine and 18 months). Intention-to-treat analyses included linear regression and repeated measurement analyses.
  
  
  RESULTS
  A borderline significant decrease in HbA1c in the intervention group compared with the control group ( - 4 vs - 1 mmol/mol or - 0.4% vs - 0.1%; P = 0.073) was driven by a significantly greater reduction in the GSD women ( - 5 vs + 1 mmol/mol or - 0.5% vs + 0.1%; P = 0.017); parallel decreases were observed in the GSD and control men ( - 3 mmol/mol or  - 0.3%; P = 0.955). Significantly greater reduction in the GSD group's psychosocial distress was again driven by differences between the GSD and the control women. The men's improvements were not connected with the intervention.
  
  
  CONCLUSIONS
  The flexible GSD intervention benefitted younger adult women by significantly improving glycaemic control and decreasing diabetes related distress. No effect was seen among men.
authors.affiliation: Steno Diabetes Center A/S, Gentofte, Denmark.|Research Unit Women's and Children's Health, The Juliane Marie Centre, Copenhagen University Hospital, Copenhagen, Denmark.
authors.forename: V
authors.initials: V
authors.lastname: Zoffmann
authors.affiliation: Steno Diabetes Center A/S, Gentofte, Denmark.
authors.forename: D
authors.initials: D
authors.lastname: Vistisen
authors.affiliation: Steno Diabetes Center A/S, Gentofte, Denmark.|King's College Faculty of Nursing and Midwifery, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Due-Christensen
mesh_terms: D000293:Adolescent; D000328:Adult; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000523:psychology / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D026684:Personal Autonomy; D011613:Psychotherapy / Q000379:methods*; D012737:Sex Factors; D013315:Stress, Psychological / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D006442:Glycated Hemoglobin