Evidence mapPaperPMID 30070928Full record

Trial reportDiabetes technology & therapeutics2018

Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes.

Bruce A Buckingham, Mark P Christiansen, Gregory P Forlenza, R Paul Wadwa, Thomas A Peyser, Joon Bok Lee, Jason O'Connor, Eyal Dassau, Lauren M Huyett, Jennifer E Layne and 1 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Diabetes technology & therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
field-weighted citation impact
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

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Real-World User and Clinician Perspective and Experience with MiniMed™ 780G Advanced Hybrid Closed Loop System.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Prospective Independent Evaluation of the Carbohydrate Counting Accuracy of Two Smartphone Applications.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  14. Article
  15. Review
  16. Review of the OmnipodTherapeutic delivery · 2020
    Review
  17. Automated Insulin Delivery in Adults.Endocrinology and metabolism clinics of North America · 2020
    Review
  18. Review
  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

11 authors.

Bruce A Buckingham1 Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University , Stanford, California.
Mark P Christiansen2 Diablo Clinical Research , Walnut Creek, California.
Gregory P Forlenza3 Barbara Davis Center for Diabetes, University of Colorado School of Medicine , Aurora, Colorado.
R Paul Wadwa3 Barbara Davis Center for Diabetes, University of Colorado School of Medicine , Aurora, Colorado.
Thomas A Peyser4 ModeAGC LLC , Palo Alto, California.
Joon Bok Lee5 Insulet Corporation , Billerica, Massachusetts.
Jason O'Connor5 Insulet Corporation , Billerica, Massachusetts.
Eyal Dassau6 Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University , Cambridge, Massachusetts.
Lauren M Huyett5 Insulet Corporation , Billerica, Massachusetts.
Jennifer E Layne5 Insulet Corporation , Billerica, Massachusetts.
Trang T Ly5 Insulet Corporation , Billerica, Massachusetts.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study assessed the safety and performance of the Omnipod MATERIALS AND

methodsA supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient open-loop run-in phase. Adults aged 18-65 years with type 1 diabetes and HbA1c 6.0%-10.0% were eligible. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Glycemic responses for 4 h to a 130% overestimated bolus and a missed meal bolus were compared with a 100% bolus for identical meals, respectively. The 12-h postprandial responses to a high-fat meal were compared using either a standard or extended bolus.

resultsTwelve subjects participated in the study, with (mean ± standard deviation): age 35.4 ± 14.1 years, diabetes duration 16.5 ± 9.3 years, HbA1c 7.7 ± 0.9%, and total daily dose 0.58 ± 0.19 U/kg. Outcomes for the 54-h HCL period were mean glucose 153 ± 15 mg/dL, percentage time <70 mg/dL [median (interquartile range)]: 0.0% (0.0-1.2%), 70-180 mg/dL: 76.1% ± 8.0%, and ≥250 mg/dL: 4.5% ± 3.6%. After both the 100% and 130% boluses, postprandial percentage time <70 mg/dL was 0.0% (0.0-0.0%) (P = 0.50). After the 100% and missed boluses, postprandial percentage time ≥250 mg/dL was 0.2% ± 0.6% and 10.3% ± 16.5%, respectively (P = 0.06). Postprandial percentages time ≥250 mg/dL and <70 mg/dL were similar with standard or extended boluses for a high-fat meal.

conclusionsThe Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to overestimated, missed, and extended meal boluses in adults with type 1 diabetes.

Indexed as

AdultAlgorithmsBlood GlucoseDiabetes Mellitus, Type 1Feeding BehaviorFemaleHumansHypoglycemic AgentsInsulinMaleMiddle AgedPancreas, ArtificialPostprandial PeriodYoung AdultBlood GlucoseHypoglycemic AgentsInsulinArtificial pancreasAutomated insulin deliveryClosed-loopOmnipodPostprandialtubeless Insulin pump

Identifiers

PMID30070928
PMCPMC6114075

What Socratic holds

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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 Socratic graph.