Evidence map›Paper›PMID 26292674›Full record

Trial reportBMC endocrine disorders2015

HypoAware-a brief and partly web-based psycho-educational group intervention for adults with type 1 and insulin-treated type 2 diabetes and problematic hypoglycaemia: design of a cost-effectiveness randomised controlled trial.

Stefanie M P A Rondags, Maartje de Wit, Maurits W van Tulder, Michaela Diamant, Frank J Snoek

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC endocrine disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Stefanie M P A RondagsDepartment of Medical Psychology, VU University Medical Centre, Van der Boechorststraat 7 (D-342), Amsterdam, 1081 BT, The Netherlands. s.rondags@vumc.nl.
Maartje de WitDepartment of Medical Psychology, VU University Medical Centre, Van der Boechorststraat 7 (D-342), Amsterdam, 1081 BT, The Netherlands. m.dewit@vumc.nl.
Maurits W van TulderEMGO+ Institute for Health and Care Research, VU University Medical Centre, Amsterdam, The Netherlands. maurits.van.tulder@vu.nl.
Michaela DiamantDepartment of Internal Medicine & Diabetes Center, VU University Medical Centre, Amsterdam, The Netherlands.
Frank J SnoekDepartment of Medical Psychology, VU University Medical Centre, Van der Boechorststraat 7 (D-342), Amsterdam, 1081 BT, The Netherlands. fj.snoek@vumc.nl.
Amsterdam UMC Location VUmc · NLEMGO Institute for Health and Care Research · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProblematic hypoglycaemia is a significant problem among people with insulin-treated type 1 and 2 diabetes mellitus, which adversely affects quality of life and leads to high societal costs. Blood glucose awareness training (BGAT) is a psycho-educational group intervention that has shown to be effective but difficult to implement in clinical practice, due to its demanding nature. The aim of this study is to evaluate the cost-effectiveness of the HypoAware intervention that has its roots in BGAT and helps patients to effectively recognize, treat and prevent hypoglycaemia, while also focussing on the psychosocial consequences of living with the constant risk of hypoglycaemia, both for patients and their significant others. METHODS/

designAn economic evaluation will be conducted alongside a cluster-randomised controlled trial in eight hospitals in the Netherlands. We aim to include 154 participants who will either receive HypoAware or care as usual. HypoAware consists of three group sessions and is combined with two online modules. The primary clinical outcome is severe hypoglycaemia. Secondary outcomes include mild hypoglycaemia, hypoglycaemia awareness, fear of hypoglycaemia, diabetes distress, anxiety and depression, health-related quality of life, diabetes-specific self-efficacy and HbA1c. Utilities will be measured using the EQ-5D-5 L questionnaire. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline, 2, 4, and 6 months to compare both groups, and an additional 12 months for the intervention group only. Process outcomes will be gathered after every group meeting via telephone/email contact with health care professionals and via the online environment. DISCUSSION: HypoAware is expected to significantly reduce episodes of severe hypoglycaemia, with subsequent beneficial effects on psychosocial outcomes and health care costs. When proven cost-effective, HypoAware will be incorporated in the clinical guidelines of Dutch diabetes care.

trial registrationDutch Trial Register NTR4538.

Indexed as

Health Care CostsInternetAdolescentAdultAnxietyAwarenessCost-Benefit AnalysisDepressionDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2FemaleHumansHypoglycemiaHypoglycemic AgentsInsulinMaleHypoglycemic AgentsInsulin

Identifiers

PMID26292674
PMCPMC4546185
OpenAlexW1933225653

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.