Evidence map›Paper›PMID 24876535›Full record

ArticleJournal of diabetes science and technology2014

Closed-Loop Control Performance of the Hypoglycemia-Hyperglycemia Minimizer (HHM) System in a Feasibility Study.

Daniel A Finan, Thomas W McCann, Linda Mackowiak, Eyal Dassau, Stephen D Patek, Boris P Kovatchev, Francis J Doyle, Howard Zisser, Henry Anhalt, Ramakrishna Venugopalan

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Article in Journal of diabetes science and technology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Article
  7. Hypo- and Hyperglycemic Alarms: Devices and Algorithms.Journal of diabetes science and technology · 2015
    Review
  8. Article
  9. Article
  10. 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

10 authors.

Daniel A FinanAnimas Corporation, West Chester, PA, USA dfinan@its.jnj.com.
Thomas W McCannAnimas Corporation, West Chester, PA, USA.
Linda MackowiakAnimas Corporation, West Chester, PA, USA.
Eyal DassauUniversity of California, Santa Barbara, Santa Barbara, CA, USA Sansum Diabetes Research Institute, Santa Barbara, CA, USA.
Stephen D PatekUniversity of Virginia, Charlottesville, VA, USA.
Boris P KovatchevUniversity of Virginia, Charlottesville, VA, USA.
Francis J DoyleUniversity of California, Santa Barbara, Santa Barbara, CA, USA Sansum Diabetes Research Institute, Santa Barbara, CA, USA.
Howard ZisserUniversity of California, Santa Barbara, Santa Barbara, CA, USA Sansum Diabetes Research Institute, Santa Barbara, CA, USA.
Henry AnhaltAnimas Corporation, West Chester, PA, USA.
Ramakrishna VenugopalanAnimas Corporation, West Chester, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis feasibility study investigated the insulin-delivery characteristics of the Hypoglycemia-Hyperglycemia Minimizer (HHM) System-an automated insulin delivery device-in participants with type 1 diabetes.

methodsThirteen adults with type 1 diabetes were enrolled in this nonrandomized, uncontrolled, clinical-research-center-based feasibility study. The HHM System comprised a continuous subcutaneous insulin infusion pump, a continuous glucose monitor (CGM), and a model predictive control algorithm with a safety module, run on a laptop platform. Closed-loop control lasted approximately 20 hours, including an overnight period and two meals.

resultsWhen attempting to minimize glucose excursions outside of a prespecified target zone, the predictive HHM System decreased insulin infusion rates below the participants' preset basal rates in advance of below-zone excursions (CGM < 90 mg/dl), and delivered 80.4% less insulin than basal during those excursions. Similarly, the HHM System increased infusion rates above basal during above-zone excursions (CGM > 140 mg/dl), delivering 39.9% more insulin than basal during those excursions. Based on YSI, participants spent a mean ± standard deviation (SD) of 0.2 ± 0.5% of the closed-loop control time at glucose levels < 70 mg/dl, including 0.3 ± 0.9% for the overnight period. The mean ± SD glucose based on YSI for all participants was 164.5 ± 23.5 mg/dl. There were nine instances of algorithm-recommended supplemental carbohydrate administrations, and there was no severe hypoglycemia or diabetic ketoacidosis.

conclusionsResults of this study indicate that the current HHM System is a feasible foundation for development of a closed-loop insulin delivery device.

Indexed as

algorithmartificial pancreasclosed-loop controlmodel predictive controltype 1 diabetes

Identifiers

PMID24876535
PMCPMC4454115

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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 OpenQuestion graph.