Evidence map›Paper›PMID 24804697›Full record

Trial reportDiabetes care2014

A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes.

David M Maahs, Peter Calhoun, Bruce A Buckingham, H Peter Chase, Irene Hramiak, John Lum, Fraser Cameron, B Wayne Bequette, Tandy Aye, Terri Paul and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01591681 (Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension), which is not on this map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
16.5field-weighted citation impact, top 1% 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.

NCT01591681 phase2completednot on this map

Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension: An Outpatient Pilot Feasibility and Efficacy Study

TypeinterventionalSponsorJaeb Center for Health ResearchRan2012 to 2013Enrolled49ConditionsType 1 DiabetesArmsPump suspension
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 158 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

16 authors at 4 institutions in 2 countries.

David M MaahsBarbara Davis Center for Childhood Diabetes, Aurora, CO.
Peter CalhounJaeb Center for Health Research, Tampa, FL.
Bruce A BuckinghamStanford University, Stanford, CA.
H Peter ChaseBarbara Davis Center for Childhood Diabetes, Aurora, CO.
Irene HramiakSt. Joseph's Health Care, London, Ontario, Canada.
John LumJaeb Center for Health Research, Tampa, FL.
Fraser CameronRensselaer Polytechnic Institute, Troy, NY.
B Wayne BequetteRensselaer Polytechnic Institute, Troy, NY.
Tandy AyeStanford University, Stanford, CA.
Terri PaulSt. Joseph's Health Care, London, Ontario, Canada.
Robert SloverBarbara Davis Center for Childhood Diabetes, Aurora, CO.
R Paul WadwaBarbara Davis Center for Childhood Diabetes, Aurora, CO.
Darrell M WilsonStanford University, Stanford, CA.
Craig KollmanJaeb Center for Health Research, Tampa, FL.
Roy W BeckJaeb Center for Health Research, Tampa, FL rbeck@jaeb.org.
In Home Closed Loop Study Group
Jaeb Center for Health Research · USStanford University · USRensselaer Polytechnic Institute · USSt Joseph's Health Care · CA

Funding

Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
Type I Diabetes Trialnet at StsnfordU01DK061042 · NIDDK · STANFORD UNIVERSITY · PI WILSON, DARRELL M · 2001 to 2018
$8.5M
In home closed loop reduction of nocturnal hypoglycemia and daytime hyperglycemiaR01DK085591 · NIDDK · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI BECK, ROY W., BUCKINGHAM, BRUCE A · 2009 to 2013
$3.9M
NCATS NIH HHS UL1 TR001085NIDDK NIH HHS R01 DK085591NIDDK NIH HHS R01-DK-085591NIDDK NIH HHS U01 DK061042
6 · The paper itself

Abstract

objectiveOvernight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness, seizure, or even death. We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring (CGM) glucose levels. RESEARCH DESIGN AND

methodsFollowing an initial run-in phase, a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active (intervention night) or inactive (control night). The primary outcome was the proportion of nights in which ≥1 CGM glucose values ≤60 mg/dL occurred.

resultsOvernight hypoglycemia with at least one CGM value ≤60 mg/dL occurred on 196 of 942 (21%) intervention nights versus 322 of 970 (33%) control nights (odds ratio 0.52 [95% CI 0.43-0.64]; P < 0.001). Median hypoglycemia area under the curve was reduced by 81%, and hypoglycemia lasting >2 h was reduced by 74%. Overnight sensor glucose was >180 mg/dL during 57% of control nights and 59% of intervention nights (P = 0.17), while morning blood glucose was >180 mg/dL following 21% and 27% of nights, respectively (P < 0.001), and >250 mg/dL following 6% and 6%, respectively. Morning ketosis was present <1% of the time in each arm.

conclusionsUse of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis.

Indexed as

AdolescentAdultAlgorithmsBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Diabetic KetoacidosisFemaleHumansHypoglycemiaHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleMiddle AgedYoung AdultBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID24804697
PMCPMC4067393
OpenAlexW2135777748

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.