Evidence map›Paper›PMID 33819289›Full record

Observational studyPloS one2021

Safety and glycemic outcomes of do-it-yourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes.

Andrzej Gawrecki, Dorota Zozulinska-Ziolkiewicz, Magdalena A Michalak, Anna Adamska, Michal Michalak, Urszula Frackowiak, Justyna Flotynska, Monika Pietrzak, Szymon Czapla, Bernhard Gehr and 1 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
5.1field-weighted citation impact, top 4% 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

19 citing papers in PubMed, 45 citations in OpenAlex.

  1. Trial
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  9. Observational
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  17. Review
  18. Automated Insulin Delivery Systems: Today, Tomorrow and User Requirements.Journal of diabetes science and technology · 2021
    Article
  19. [Individualization of diabetes treatment by automated insulin delivery].Monatsschrift Kinderheilkunde : Organ der Deutschen Gesellschaft fur Kinderheilkunde · 2021
    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

11 authors at 2 institutions in 2 countries.

Andrzej GawreckiDepartment of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.
Dorota Zozulinska-ZiolkiewiczDepartment of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.
Magdalena A MichalakDepartment of Diabetology and Internal Medicine, Raszeja Hospital, Poznan, Poland.
Anna AdamskaDepartment of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.
Michal MichalakDepartment of Computer Sciences and Statistics, Poznan University of Medical Sciences, Poznan, Poland.
Urszula FrackowiakDepartment of Diabetology and Internal Medicine, Raszeja Hospital, Poznan, Poland.
Justyna FlotynskaDepartment of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.
Monika PietrzakDepartment of Diabetology and Internal Medicine, Raszeja Hospital, Poznan, Poland.
Szymon CzaplaNightscout Poland, Kielce, Poland.
Bernhard GehrZentrum für Diabetes und Stoffwechselerkrankungen, m&i Fachklinik, Bad Heilbrunn, Germany.
Aleksandra AraszkiewiczDepartment of Internal Medicine and Diabetology, Poznan University of Medical Sciences, Poznan, Poland.ORCID 0000-0002-4955-6099
Poznan University of Medical Sciences · PLDiabetes-Akademie · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of the study was to assess the safety and glycemic outcomes with the use of a Do-It-Yourself (DIY) Hybrid Closed-Loop (HCL) system based on the AndroidAPS application in type 1 diabetes (T1D).

methodsSingle-center clinical trial, with 3-week run-in and 12-week study period. DIY HCL system consisted of the Dana Diabecare RS insulin pump, Dexcom G5 continuous glucose monitoring system and AndroidAPS application. Primary outcome was safety: incidences of severe hypoglycemia, diabetic ketoacidosis, time spent in glycemia <54 mg/dl. Secondary endpoints included percentage of time in range (TIR) 70-180 mg/dl, time below 70 mg/dl, HbA1c, insulin requirements, and body weight.

resultsIn total 12 subjects (5 men, 7 women) were enrolled, mean age 31.3±6.7, 95%CI(27.7-34.9) years, mean diabetes duration 16.1±5.7, 95%CI(13.0-19.2) years. No episodes of severe hypoglycemia or ketoacidosis were observed. Percentage of time spent in glycemia below 54mg/dl was not increased. Average sensor glycemia was lower in the study period than baseline (141.1 ± 8.4, 95%CI(136.3-145.9) vs. 153.3 ± 17.9, 95%CI(143.2-163.4), mg/dl p<0.001). TIR 70-180 mg/dl was improved by 11.3%, 95%CI(2.8%-19.8%) (from 68.0 ± 12.7 to 79.3 ± 6.4%, p<0.001), without increasing hypoglycemia time. The HbA1c level decreased by -0.5%, 95%CI(-0.9%--0.1%) (from 6.8 ± 0.5 to 6.3 ± 0.4%, p<0.001). Additionally, in the last 4 weeks of the study period participants significantly improved and showed TIR 70-180 mg/dl 82.1 ± 5.6%, 95%CI(78.9-85.3), time <54 mg/dl 0.30 (0.20-0.55)%, median 95%CI(0.1-0.7) and <70 mg/dl 1.90 (1.10-3.05)%, median 95%CI(0.7-3.2). The insulin requirement and body weight did not change in the study.

conclusionsThe study revealed safety of the Do-It-Yourself HCL system AndroidAPS in adults with T1D, limited to well-controlled, highly selected and closely monitored patients. The use of AndroidAPS significantly improved HbA1c, time in range and average sensor glycemia without increasing hypoglycemia. As both patients and their medical team are gaining experience using the system over time, they improve glycemic control.

trial registrationGerman Clinical Trials Register: no. DRKS00015439; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015439.

Indexed as

Blood Glucose Self-MonitoringDiabetes Mellitus, Type 1InsulinSoftwareAdultFemaleHumansHypoglycemiaHypoglycemic AgentsMaleHypoglycemic AgentsInsulin

Identifiers

PMID33819289
PMCPMC8021167
OpenAlexW3139599658

What Socratic holds

Textmetadata
LicenceCC BY
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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.