Evidence mapPaperPMID 38634887Full record

Trial reportDiabetologia2024

Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial.

Ji Yoon Kim, Sang-Man Jin, Eun Seok Kang, Soo Heon Kwak, Yeoree Yang, Jee Hee Yoo, Jae Hyun Bae, Jun Sung Moon, Chang Hee Jung, Ji Cheol Bae and 5 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07425912 (Real-World Efficacy and Safety of the TouchCare Nano Automated Insulin Delivery System With APGO Algorithm in Children and Adolescents With Type 1 Diabetes), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
4.3field-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.

NCT07425912 completednot on this mapstarted 2025, after this paper: background citation

Real-World Efficacy and Safety of the TouchCare Nano Automated Insulin Delivery System With APGO Algorithm in Children and Adolescents With Type 1 Diabetes: A Multicentre Observational Study

TypeobservationalSponsorUniversity of Campania Luigi VanvitelliRan2025 to 2026Enrolled76ConditionsType 1 Diabetes Mellitus
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Automated Insulin Delivery for Type 1 Diabetes: Present and Future.Diabetes spectrum : a publication of the American Diabetes Association · 2025
    Article
  8. Review
  9. Review
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

15 authors at 11 institutions in 1 country.

Ji Yoon KimDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-6626-2124
Sang-Man JinDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-5929-3627
Eun Seok KangDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-0364-4675
Soo Heon KwakDivision of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-1230-0919
Yeoree YangDivision of Endocrinology, Department of Internal Medicine, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-0990-1502
Jee Hee YooDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.ORCID http://orcid.org/0000-0002-2536-6274
Jae Hyun BaeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-1384-6123
Jun Sung MoonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.ORCID http://orcid.org/0000-0003-1569-3068
Chang Hee JungDivision of Endocrinology and Metabolism, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-4043-2396
Ji Cheol BaeDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.ORCID http://orcid.org/0000-0002-4763-5797
Sunghwan SuhDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.ORCID http://orcid.org/0000-0001-6865-966X
Sun Joon MoonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-6286-7254
Sun Ok SongDivision of Endocrinology and Metabolism, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.ORCID http://orcid.org/0000-0003-4829-3407
Suk ChonDepartment of Endocrinology and Metabolism, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0001-5921-2989
Jae Hyeon KimDivision of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. jaehyeon@skku.edu.ORCID http://orcid.org/0000-0001-5001-963X
Samsung Medical Center · KRKorea University · KRYonsei University · KRKangbuk Samsung Hospital · KRKyung Hee University · KRNational Health Insurance Service Ilsan Hospital · KRSamsung (South Korea) · KRSeoul National University Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRUlsan College · KRYeungnam University College

Funding

Korea Medical Device Development Fund RS-2020-KD000056
6 · The paper itself

Abstract

aims/hypothesisThis study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP).

methodsThis multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19-69 years with type 1 diabetes who had HbA

resultsA total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA CONCLUSIONS/

interpretationThe use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP.

trial registrationClinical Research Information Service (CRIS) KCT0008398

fundingThe study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

Indexed as

Blood GlucoseDiabetes Mellitus, Type 1Hypoglycemic AgentsInsulinInsulin Infusion SystemsAdultAgedBlood Glucose Self-MonitoringFemaleGlycated HemoglobinHumansMaleMiddle AgedRepublic of KoreaYoung AdultBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinArtificial pancreasAutomated insulin deliveryHybrid closed-loopOn-body automated insulin delivery systemSensor-augmented pumpTubeless patch pumpType 1 diabetes

Identifiers

PMID38634887
OpenAlexW4394920696

What Socratic 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 Socratic graph.