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

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

doi:10.2337/dc16-1614

Cited by 45Diabetes Management and ResearchDiabetes Management and EducationPatient Safety and Medication Errors

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

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Rondags, Stefanie M.P.A., de Wit, Maartje, Twisk, Jos W., Snoek, Frank J.·2016·Diabetes Care

DOI 10.2337/dc16-1614

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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.

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Several clinical trials have not shown a reduction of IAH by using CGM despite a reduced incidence of level 3 hypoglycemia.
“Several clinical trials have not shown a reduction of IAH by using CGM despite a reduced incidence of level 3 hypoglycemia (101,112,124,126-128).”
From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [127]
The Conclusions state that RT-CGM has been found effective in preventing severe hypoglycemia. They do not say that CGM trials failed to reduce impaired hypoglycemia awareness (IAH), or report that pattern across several trials. This paper’s own trial tested HypoAware, not CGM. (LLM, conf=0.83)
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HypoAware: development and pilot study of a brief and partly web‐based psychoeducational group intervention for adults with Type 1 and insulin‐treated Type 2 diabetes and problematic hypoglycaemia
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Authors: Rondags, S. M. P. A., de Wit, M., Twisk, J. W., & Snoek, F. J.
Affiliations: Amsterdam Public Health (NL)
Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands
Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
Amsterdam UMC Location University of Amsterdam (NL)
Corresponding author: Snoek, Frank J.
ORCID: Rondags, Stefanie M.P.A.
Twisk, Jos W.
Snoek, Frank J.
Venue: Diabetes Care
Publisher: American Diabetes Association
Published: 2016-10-20
Volume: 39
Issue: 12
Pages: 2190-2196
ISSN: 0149-5992 (ISSN-L)
1935-5548
DOI: 10.2337/dc16-1614
OpenAlex: W2537159981
Cited by: 45
References: 29
Citations by year: 2026: 6 · 2024: 5 · 2023: 6 · 2022: 3 · 2021: 4 · 2020: 2 · 2019: 2 · 2018: 6 · 2017: 10 · 2016: 1
FWCI: 6.35
Type: journal article
Language: en
Open access: green
pure.amsterdamumc.nl
Licence: other-oa
www.diabetesjournals.org/content/license (vor, 33 d)
Locations: Diabetes Care (publishedVersion)
PubMed (publishedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
Pure Amsterdam UMC (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: ZonMw (837001406),)
Novo Nordisk
Achmea
VU University Medical Center
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
Keywords: hypoglycemia, hypoglycemia awareness, type 1 diabetes, type 2 diabetes, insulin-treated diabetes, psychoeducational intervention, severe hypoglycemia, fear of hypoglycemia, HbA1c, glycemic control, diabetes self-management education
MeSH terms: Adult, Awareness, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Patient Education as Topic, Surveys and Questionnaires, Internet

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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

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