Work

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

Year: 2016

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: OBJECTIVE 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. RESEARCH DESIGN AND METHODS 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. RESULTS 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 HbA1c level within and between both groups. CONCLUSIONS HypoAware resulted in fewer severe hypoglycemic episodes, significantly improved hypoglycemia awareness, and less hypo-distress in comparison with usual care, and deserves further dissemination.

Source: Diabetes Care

DOI: 10.2337/dc16-1614

Authors: Stefanie M.P.A. Rondags, Maartje de Wit, Jos W. Twisk, Frank J. Snoek

Institutions: Amsterdam Public Health, Amsterdam UMC Location Vrije Universiteit Amsterdam, Amsterdam UMC Location University of Amsterdam

Language: English

Topic: Diabetes Management and Research

Subfield: Endocrinology, Diabetes and Metabolism

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green