Evidence map›Paper›PMID 38253252›Full record

ArticleContemporary clinical trials2024

Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial.

James D Ralston, Melissa Anderson, Janet Ng, Ayat Bashir, Kelly Ehrlich, Dena Burns-Hunt, Meredith Cotton, Laurel Hansell, Clarissa Hsu, Helen Hunt and 15 more

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04863872 (Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 41% 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.

NCT04863872 nacompletednot on this map

Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia

TypeinterventionalSponsorKaiser PermanenteRan2022 to 2024Enrolled259ConditionsSevere HypoglycemiaArmsProactive Care Management, MyHC-T2D education program
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 5 institutions in 2 countries.

James D RalstonKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA; Washington Permanente Medical Group, 125 16th Ave E, Seattle, WA, USA. Electronic address: james.d.ralston@kp.org.
Melissa AndersonKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Janet NgKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Ayat BashirTranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne NE1 7RU, UK.
Kelly EhrlichKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Dena Burns-HuntKaiser Permanente Washington, 2715 Naches Ave SW, Renton, WA 98057, USA.
Meredith CottonDepartment of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, USA.
Laurel HansellKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Clarissa HsuKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Helen HuntKaiser Permanente Washington, 2715 Naches Ave SW, Renton, WA 98057, USA.
Andrew J KarterDepartment of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, USA.
Shaula M LevyKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Evette LudmanKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Lawrence MadziwaKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Emily M OmuraWashington Permanente Medical Group, 125 16th Ave E, Seattle, WA, USA.
Kristine RogersKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Brandie SeveyKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
James A M ShawTranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne NE1 7RU, UK.
Susan M ShortreedKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA; University of Washington, Department of Biostatistics, 3980 15th Avenue NE, Box 351617, Seattle, WA 98195, USA.
Umesh SinghKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Jane SpeightAustralian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Suite G01, 15-31 Pelham Street, Carlton, Victoria, Australia; School of Psychology, Institute for Health Transformation, Deakin University, Geelong, Victoria, Australia.
Amber SweenyDepartment of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA, USA.
Katherine TschernischKaiser Permanente Washington, 2715 Naches Ave SW, Renton, WA 98057, USA.
S Sergei TschernischKaiser Permanente Washington, 2715 Naches Ave SW, Renton, WA 98057, USA.
Laura YarboroughKaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA.
Kaiser Permanente Washington Health Research Institute · USKaiser Permanente · USColorado Permanente Medical Group · USNewcastle University · GBUniversity of Washington · US

Funding

Translational Research Core - Health Engagement & Action Translational (HEAT)P30DK092924 · NIDDK · KAISER FOUNDATION RESEARCH INSTITUTE · PI Alyce Sophia Adams, HILARY Kessler SELIGMAN · 2011 to 2026
$9.2M
Severe Hypoglycemia: Ascertainment, Surveillance and PharmacovigilanceR01DK103721 · NIDDK · KAISER FOUNDATION RESEARCH INSTITUTE · PI KARTER, ANDREW JOHN · 2015 to 2018
$2.2M
NIDDK NIH HHS P30 DK092924NIDDK NIH HHS R01 DK103721Patient-Centered Outcomes Research Institute IHS-2019C3-17889
6 · The paper itself

Abstract

backgroundSevere hypoglycemia is a common and feared complication of medications used to lower blood glucose levels in individuals with diabetes. Psychoeducational interventions can prevent severe hypoglycemia in individuals with type 1 diabetes (T1D). We aim to determine the effectiveness of this approach among adults with type 2 diabetes (T2D) at elevated risk for severe hypoglycemia.

methodsPreventing Hypoglycemia in Type 2 diabetes (PHT2) is a two-arm, parallel, randomized controlled trial. Participants are eligible if they are adults with T2D receiving care at an integrated group practice in Washington state and have experienced one or more episodes of severe hypoglycemia in the prior 12 months or have impaired awareness of hypoglycemia (Gold score ≥ 4). Participants are randomized to proactive nurse care management with or without my hypo compass, an evidence-based, psychoeducational intervention combining group and individual self-management training. For this study, my hypo compass was adapted to be suitable for adults with T2D and from an in-person to a virtual intervention over videoconference and telephone. The primary outcome is any self-reported severe hypoglycemia in the 12 months following the start of the intervention. Secondary outcomes include biochemical measures of hypoglycemia, self-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. The study includes a process evaluation to assess implementation fidelity and clarify the causal pathway.

conclusionThe PHT2 trial will compare the effectiveness of two approaches for reducing severe hypoglycemia in adults with T2D.

trial registrationclinicaltrials.gov, # NCT04863872.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaAdultBlood GlucoseBlood Glucose Self-MonitoringHumansHypoglycemic AgentsInsulinRandomized Controlled Trials as TopicBlood GlucoseHypoglycemic AgentsInsulinHypoglycemiaImpaired awareness of hypoglycemiaType 2 diabetes

Identifiers

PMID38253252
PMCPMC13645211
OpenAlexW4391070520

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.