In:
Diabetes Care, American Diabetes Association, Vol. 39, No. 12 ( 2016-12-01), p. 2190-2196
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. 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.
Type of Medium:
Online Resource
ISSN:
0149-5992
,
1935-5548
Language:
English
Publisher:
American Diabetes Association
Publication Date:
2016
detail.hit.zdb_id:
1490520-6
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