title: Effectiveness of HypoAware, a Brief Partly Web-Based Psychoeducational Intervention for Adults With Type 1 and Insulin-Treated Type 2 Diabetes and Problematic Hypoglycemia: A Cluster Randomized Controlled Trial.
abstract: To establish the effectiveness of a brief, partly web-based group intervention, HypoAware, in patients with problematic hypoglycemia, in terms of the reduction of severe hypoglycemic episodes, impaired hypoglycemia awareness, and worries.
  
  
  
  A two-arm, cluster randomized controlled trial was conducted in insulin-treated patients with problematic hypoglycemia in eight Dutch clinics comparing HypoAware with care as usual. Primary outcomes included self-reported severe hypoglycemia, impaired hypoglycemia awareness (Gold score), and worries and distress about hypoglycemia (Hypoglycemia Fear Survey-II/Problem Areas In Diabetes scale hypo-item), assessed at baseline, and at 2, 4, and 6 months of follow-up. We used t tests, nonparametric tests, and intention-to-treat generalized estimation equation (GEE) analyses with linear, logistic, and Poisson or negative binomial models.
  
  
  
  We enrolled 137 participants. Adjusted GEE analyses over four time points showed a nonsignificant 33% fewer episodes of severe hypoglycemia in the HypoAware group compared with the control group (relative risk [RR] 0.67 [95% CI 0.39-1.16], P = 0.150); a significant reduced odds of impaired awareness (odds ratio 0.38 [95% CI 0.15-0.95], P = 0.038), a trend toward 20% fewer worries about hypoglycemia (RR 0.80 [95% CI 0.64-1.01], P = 0.059), and a significant 30% less hypo-distress (RR 0.70 [95% CI 0.56-0.88], P = 0.002). Over the 6-month study duration, participants experienced a median of 2.5 events of severe hypoglycemia (interquartile range [IQR] 1-10) in the control condition versus 1 event (IQR 0-6.5) in the HypoAware group (P = 0.030). There was no significant change in HbA1clevel within and between both groups.
  
  
  
  HypoAware resulted in fewer severe hypoglycemic episodes, significantly improved hypoglycemia awareness, and less hypo-distress in comparison with usual care, and deserves further dissemination.
authors: Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands.
authors: Stefanie M P A
authors: SM
authors: Rondags
authors: Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands.
authors: Maartje
authors: M
authors: de Wit
authors: Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, the Netherlands.
authors: Jos W
authors: JW
authors: Twisk
authors: Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands fj.snoek@vumc.nl.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands.|Department of Medical Psychology, Academic Medical Center, Amsterdam, the Netherlands.
authors: Frank J
authors: FJ
authors: Snoek
mesh_terms: D000328:Adult; D001364:Awareness; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000175:diagnosis; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000009:adverse effects / Q000627:therapeutic use; D020407:Internet; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D011795:Surveys and Questionnaires
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin