Evidence map›Paper›PMID 37196353›Full record

ArticleDiabetes care2023

At-Home Use of a Pregnancy-Specific Zone-MPC Closed-Loop System for Pregnancies Complicated by Type 1 Diabetes: A Single-Arm, Observational Multicenter Study.

Carol J Levy, Yogish C Kudva, Basak Ozaslan, Kristin Castorino, Grenye O'Malley, Ravinder Jeet Kaur, Camilla M Levister, Mei Mei Church, Donna Desjardins, Shelly McCrady-Spitzer and 11 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04492566 (Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
8.6field-weighted citation impact, top 2% 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.

NCT04492566 nacompletednot on this map

Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the iAPS in Pregnant Patients With Type 1 Diabetes With Extension Into Outpatient at Home

TypeinterventionalSponsorSansum Diabetes Research InstituteRan2020 to 2022Enrolled10ConditionsType 1 Diabetes, PregnancyArmsAutomated Insulin Delivery
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Artificial Pancreas: The First 20 Years.Journal of diabetes science and technology · 2025
    Article
  11. Review
  12. Metabolic Models, in Silico Trials, and Algorithms.Journal of diabetes science and technology · 2025
    Review
  13. Metabolic Models, in Silico Trials, and Algorithms.Diabetes technology & therapeutics · 2025
    Review
  14. Review
  15. Article
  16. Optimizing Automated Insulin Delivery Systems for Pregnancy.Diabetes spectrum : a publication of the American Diabetes Association · 2025
    Article
  17. Review
  18. Article
  19. Review
  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

21 authors at 4 institutions in 1 country.

Carol J Levy1Icahn School of Medicine at Mount Sinai, New York, NY.ORCID 0000-0002-3492-2578
Yogish C Kudva2Mayo Clinic, Rochester, MN.
Basak Ozaslan3Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Boston, MA.
Kristin Castorino4Sansum Diabetes Research Institute, Santa Barbara, CA.
Grenye O'Malley1Icahn School of Medicine at Mount Sinai, New York, NY.
Ravinder Jeet Kaur2Mayo Clinic, Rochester, MN.
Camilla M Levister1Icahn School of Medicine at Mount Sinai, New York, NY.
Mei Mei Church4Sansum Diabetes Research Institute, Santa Barbara, CA.
Donna Desjardins2Mayo Clinic, Rochester, MN.
Shelly McCrady-Spitzer2Mayo Clinic, Rochester, MN.
Selassie Ogyaadu1Icahn School of Medicine at Mount Sinai, New York, NY.
Mari Charisse Trinidad2Mayo Clinic, Rochester, MN.
Corey Reid2Mayo Clinic, Rochester, MN.
Shafaq Rizvi2Mayo Clinic, Rochester, MN.
Sunil Deshpande3Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Boston, MA.
Isabella Zaniletti5Mayo Clinic, Scottsdale, AZ.
Walter K Kremers2Mayo Clinic, Rochester, MN.
Jordan E Pinsker4Sansum Diabetes Research Institute, Santa Barbara, CA.
Francis J Doyle3Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Boston, MA.
Eyal Dassau3Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Boston, MA.ORCID 0000-0001-5333-6892
LOIS-P Diabetes and Pregnancy Consortium
Mayo Clinic in Arizona · USHarvard University · USIcahn School of Medicine at Mount Sinai · USSansum Diabetes Research Institute · US

Funding

Mayo Clinic Center for Clinical and Translational Science (CCaTS UL1 Supplement - Dr. Timothy Curry)UL1TR002377 · NCATS · MAYO CLINIC ROCHESTER · PI VESNA D GAROVIC · 2017 to 2026
$78.4M
Automated Glucose Regulation to improve Diabetes Control and Outcomes for Pregnant Women with Type 1 Diabetes and FetusR01DK120358 · NIDDK · HARVARD UNIVERSITY · PI DASSAU, EYAL, KUDVA, YOGISH C. · 2018 to 2020
$2.3M
NCATS NIH HHS UL1 TR002377NIDDK NIH HHS R01 DK120358
6 · The paper itself

Abstract

objectiveThere are no commercially available hybrid closed-loop insulin delivery systems customized to achieve pregnancy-specific glucose targets in the U.S. This study aimed to evaluate the feasibility and performance of at-home use of a zone model predictive controller-based closed-loop insulin delivery system customized for pregnancies complicated by type 1 diabetes (CLC-P). RESEARCH DESIGN AND

methodsPregnant women with type 1 diabetes using insulin pumps were enrolled in the second or early third trimester. After study sensor wear collecting run-in data on personal pump therapy and 2 days of supervised training, participants used CLC-P targeting 80-110 mg/dL during the day and 80-100 mg/dL overnight running on an unlocked smartphone at home. Meals and activities were unrestricted throughout the trial. The primary outcome was the continuous glucose monitoring percentage of time in the target range 63-140 mg/dL versus run-in.

resultsTen participants (HbA1c 5.8 ± 0.6%) used the system from mean gestational age of 23.7 ± 3.5 weeks. Mean percentage time in range increased 14.1 percentage points, equivalent to 3.4 h per day, compared with run-in (run-in 64.5 ± 16.3% versus CLC-P 78.6 ± 9.2%; P = 0.002). During CLC-P use, there was significant decrease in both time over 140 mg/dL (P = 0.033) and the hypoglycemic ranges of less than 63 mg/dL and 54 mg/dL (P = 0.037 for both). Nine participants exceeded consensus goals of above 70% time in range during CLC-P use.

conclusionsThe results show that the extended use of CLC-P at home until delivery is feasible. Larger, randomized studies are needed to further evaluate system efficacy and pregnancy outcomes.

Indexed as

Diabetes Mellitus, Type 1Blood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesFemaleHumansHypoglycemic AgentsInfantInsulinInsulin Infusion SystemsInsulin, Regular, HumanPregnancyPregnancy OutcomeBlood GlucoseHypoglycemic AgentsInsulinInsulin, Regular, Human

Identifiers

PMID37196353
PMCPMC10300516
OpenAlexW4376868020

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.