Evidence map›Paper›PMID 27621142›Full record

Trial reportJournal of diabetes science and technology2016

Early Detection of Infusion Set Failure During Insulin Pump Therapy in Type 1 Diabetes.

Marzia Cescon, Daniel J DeSalvo, Trang T Ly, David M Maahs, Laurel H Messer, Bruce A Buckingham, Francis J Doyle, Eyal Dassau

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Article
  4. Review
  5. Metabolic Models, in Silico Trials, and Algorithms.Diabetes technology & therapeutics · 2025
    Review
  6. Metabolic Models, in Silico Trials, and Algorithms.Journal of diabetes science and technology · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Insulin pumps in children - a systematic review.World journal of clinical pediatrics · 2022
    Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article
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

8 authors at 5 institutions in 1 country.

Marzia CesconDepartment Chemical Engineering & Institute for Collaborative Biotechnologies, University of California, Santa Barbara, Santa Barbara, CA, USA.
Daniel J DeSalvoPediatric Diabetes and Endocrinology, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, USA.
Trang T LyDivision of Pediatric Endocrinology, Stanford School of Medicine, Stanford, CA, USA.
David M MaahsBarbara Davis Center for Diabetes, University of Colorado Denver, Aurora, CO, USA.
Laurel H MesserBarbara Davis Center for Diabetes, University of Colorado Denver, Aurora, CO, USA.
Bruce A BuckinghamDivision of Pediatric Endocrinology, Stanford School of Medicine, Stanford, CA, USA.
Francis J DoyleDepartment Chemical Engineering & Institute for Collaborative Biotechnologies, University of California, Santa Barbara, Santa Barbara, CA, USA.
Eyal DassauDepartment Chemical Engineering & Institute for Collaborative Biotechnologies, University of California, Santa Barbara, Santa Barbara, CA, USA dassau@seas.harvard.edu.
Harvard University · USStanford Medicine · USUniversity of Colorado Denver · USBaylor College of Medicine · USUniversity of California, Santa Barbara · US

Funding

Ambulatory Artificial Pancreas: merging physiology, behavior, and control designDP3DK094331 · NIDDK · UNIVERSITY OF CALIFORNIA SANTA BARBARA · PI BASU, ANANDA, DOYLE, FRANCIS J · 2011 to 2014
$4.6M
NIDDK NIH HHS DP3 DK094331
6 · The paper itself

Abstract

backgroundInsulin infusion set failure resulting in prolonged hyperglycemia or diabetic ketoacidosis can occur with pump therapy in type 1 diabetes. Set failures are frequently characterized by variable and unpredictable patterns of increasing glucose values despite increased insulin infusion. Early detection may minimize the risk of prolonged hyperglycemia, an important consideration for automated insulin delivery and closed-loop applications.

methodsA novel algorithm designed to alert the patient to the onset of infusion set failure was developed based upon continuous glucose sensor values and insulin delivered from an insulin pump. The method was calibrated on 12 weeks of infusion set wear without failures recorded by 4 patients in ambulatory conditions and prospectively validated on 18 weeks of infusion set wear with and without failures belonging to 9 other subjects in ambulatory conditions.

resultsThe algorithm, evaluated retrospectively, identified a failure 2.52 ± 1.91 days ahead of the actual event as recorded by the clinical team, corresponding to 50% sensitivity, 66% specificity and 55% accuracy. If set failure alarms had been activated in real time, the average time >180 mg/dl would be reduced from 82.7 ± 40.9 hours/week/subject (without alarm) to 58.8 ± 31.1 hours/week/subject (with alarm), corresponding to a potential 29% reduction in time spent >180mg/dl.

conclusionThe proposed method for early detection of infusion set failure based on glucose sensor and insulin data demonstrated favorable results on retrospective data and may be implemented as an additional safeguard in a future fully automated closed-loop system.

Indexed as

AlgorithmsClinical AlarmsBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Equipment FailureFemaleHumansHyperglycemiaHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleSensitivity and SpecificityBlood GlucoseHypoglycemic AgentsInsulinartificial pancreasinfusion set failures

Identifiers

PMID27621142
PMCPMC5094340
OpenAlexW2519750058

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.