Evidence map›Paper›PMID 41724265›Full record

Trial reportContemporary clinical trials2026

A pilot trial of 'HypoPals': Assessing trial procedures feasibility and intervention acceptability for a prospective digital hypoglycemia behavioral intervention study.

Yu Kuei Lin, Emily Hepworth, Juniar Lucien, Annika Agni, Adam Martin-Schwarze, Sean Newman, Nicolle Marinec, James E Aikens, Catherine Spino, Rodica Pop-Busui and 5 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Yu Kuei LinDepartment of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA. Electronic address: yuklin@med.umich.edu.
Emily HepworthDepartment of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Juniar LucienDepartment of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Annika AgniDepartment of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Adam Martin-SchwarzeDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Sean NewmanDepartment of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Nicolle MarinecDepartment of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.
James E AikensDepartment of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Catherine SpinoDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Rodica Pop-BusuiDepartment of Medicine, Oregon Health & Science University School of Medicine, Portland, OR, USA.
Jillian StrayhornDepartment of Social and Behavioral Sciences, New York University School of Global Public Health, New York, NY, USA.
Melissa DeJonckheereDepartment of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Nicole de ZoysaDepartment of Diabetes, King's College Hospital NHS Foundation Trust, London, UK.
Stephanie A AmielDepartment of Diabetes, King's College London School of Cardiovascular and Metabolic Medicine and Sciences, London, UK.
John D PietteDepartment of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.

Funding

Minimizing Hypoglycemia in Adults with Type 1 Diabetes through an Integrated Mobile Health and Continuous Glucose Monitoring SystemK23DK129724 · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2025 to 2025
$197k
NIDDK NIH HHS K23 DK129724
6 · The paper itself

Abstract

backgroundDespite advances in diabetes technology, hypoglycemia remains a major problem for people with type 1 diabetes (T1D). We developed HypoPals, a scalable digital behavioral intervention program comprised of two intervention components, (i) hypoglycemia symptom detection training ('SDT') and (ii) psychoeducation to address unhelpful hypoglycemia beliefs (Education Plus, 'ED+'), to improve hypoglycemia self-management in adults with T1D.

methodsA 52-week pilot study was conducted to assess the feasibility of a prospective decentralized 2 × 2 factorial trial with the following characteristics: participant recruitment from a national T1D patient registry; minimization randomization; and remote outcome data collection to evaluate the effectiveness of HypoPals intervention components. This pilot study's primary outcome was the number of participants needed to achieve 20 participants completing the intervention. Intervention acceptability was also assessed.

resultsForty participants were randomized to receive 10 weeks of either SDT only; ED+ only; both; or usual care only. All participants completed the intervention. Thus, 20 participants were recruited to achieve 20 participants completing the intervention. No significant differences in baseline characteristics were observed across randomization groups. Retention was 98% at the 26- and 52-week follow-ups, and 98% of participants provided complete outcome data. The majority (88%) found HypoPals at least somewhat helpful. No adverse events were determined to be related to the intervention.

conclusionsThis pilot trial demonstrated the feasibility of both integrating multiple advanced trial strategies and the intervention's acceptability. Results supported the conduct of a large-scale, decentralized, factorial trial to evaluate HypoPals' effectiveness in reducing hypoglycemia in adults with T1D.

Indexed as

Diabetes Mellitus, Type 1HypoglycemiaPatient Education as TopicSelf-ManagementAdultFeasibility StudiesFemaleHumansHypoglycemic AgentsMaleMiddle AgedPilot ProjectsProspective StudiesHypoglycemic AgentsBehavioral interventionDigital interventionHypoglycemiaPilot studyType 1 diabetes

Identifiers

PMID41724265
PMCPMC13215259

What Socratic holds

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Registered trials

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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 Socratic graph.