Evidence mapPaperPMID 40607635Full record

ArticleJournal of diabetes science and technology2025

First in Human Feasibility Study: Automated Insulin Delivery Utilizing a Self-Adapting Algorithm in Adults With Type 1 and Type 2 Diabetes.

Tom Wilkinson, Solita Donnelly, Claire Lever, Jonathan Williman, Renee Meier, Alisa Boucsein, Shirley Jones, Dave Ballagh, Reon van Rensburg, Rachael Sampson and 5 more

Abstract read
In one paragraph

Article in Journal of diabetes science and technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Revolutionizing Diabetes Care: From Tech to Therapeutics.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
    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

15 authors.

Tom WilkinsonDepartment of Pediatrics, University of Otago Christchurch, Christchurch, New Zealand.ORCID 0000-0002-9025-3778
Solita DonnellyAotearoa Diabetes Collective, Waikato, New Zealand.
Claire LeverAotearoa Diabetes Collective, Waikato, New Zealand.
Jonathan WillimanDepartment of Population Health, University of Otago Christchurch, Christchurch, New Zealand.
Renee MeierDepartment of Pediatrics, University of Otago Christchurch, Christchurch, New Zealand.
Alisa BoucseinDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Shirley JonesDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Dave BallaghTe Whatu Ora Nelson Marlborough, Blenheim, New Zealand.
Reon van RensburgTe Whatu Ora Nelson Marlborough, Blenheim, New Zealand.
Rachael SampsonAotearoa Diabetes Collective, Waikato, New Zealand.
Enrique Campos-NáñezDexcom Incorporated, San Diego, CA, USA.
Steve PatekDexcom Incorporated, San Diego, CA, USA.
Ryan PaulAotearoa Diabetes Collective, Waikato, New Zealand.
Benjamin WheelerDepartment of Women's and Children's Health, University of Otago, Dunedin, New Zealand.ORCID 0000-0003-3348-5238
Martin de BockDepartment of Pediatrics, University of Otago Christchurch, Christchurch, New Zealand.ORCID 0000-0003-0454-6679

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis feasibility study assessed a novel self-adapting closed-loop system which does not require carbohydrate announcement, in adults with type 1 and type 2 diabetes.

methodsSingle-arm study, comprising a 14-day run-in using participants' usual insulin therapy with a blinded continuous glucose monitor (CGM), followed by 12 weeks use of the novel closed-loop system. The algorithm adjusted its own parameters after 4, 6, 8, and 10 weeks of use.

resultsThirty-two participants with type 1 and 10 participants with type 2 diabetes were enrolled. Mean time in range (TIR; % CGM readings = 70-180 mg/dL) was 37.7% at baseline and 55.9% during the intervention period in type 1 diabetes; 17.6% at baseline and 51.5% during the intervention period in type 2 diabetes. Median time <70 mg/dL during the intervention period was 1.1% in type 1 and 0.0% in type 2 diabetes. Median TIR was 65% following the fourth algorithm adaptation. Median daily insulin delivered by manual bolus was 1.0 units in type 1 and 0.0 units in type 2 diabetes, consistent with no meal announcement. There were four serious adverse events: worsening retinopathy, severe hypoglycemia following a period of paused automation, and two hospitalizations unrelated to the device.

conclusionsA closed-loop algorithm that adjusts its own parameters and requires no meal announcement was feasible in a cohort of adults with type 1 and type 2 diabetes. Clinical benefits were most apparent with the fully adapted algorithm.

Indexed as

automated insulin deliveryfully automated closed-loop systemtype 1 diabetestype 2 diabetesunannounced meals

Identifiers

PMID40607635
PMCPMC12226515

What Socratic holds

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Registered trials

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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.