Evidence map›Paper›PMID 20393188›Full record

Trial reportScience translational medicine2010

A bihormonal closed-loop artificial pancreas for type 1 diabetes.

Firas H El-Khatib, Steven J Russell, David M Nathan, Robert G Sutherlin, Edward R Damiano

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Science translational medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 171 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
171citing papers in PubMed, 2 pooled it
–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

171 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  9. Psychosocial Impact of the Bionic Pancreas During Summer Camp.Journal of diabetes science and technology · 2016
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  17. An integrated multivariable artificial pancreas control system.Journal of diabetes science and technology · 2014
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111 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Firas H El-Khatib *Department of Biomedical Engineering, Boston University and the Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Steven J Russell *Department of Biomedical Engineering, Boston University and the Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
David M NathanDepartment of Biomedical Engineering, Boston University and the Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Robert G SutherlinDepartment of Biomedical Engineering, Boston University and the Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Edward R DamianoDepartment of Biomedical Engineering, Boston University and the Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA.

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI HALL, JANET E · 1985 to 2008
$37.4M
NCRR NIH HHS 1-UL1-RR025758-01NCRR NIH HHS RR01066NCRR NIH HHS UL1 RR025758
6 · The paper itself

Abstract

Automated control of blood glucose (BG) concentration is a long-sought goal for type 1 diabetes therapy. We have developed a closed-loop control system that uses frequent measurements of BG concentration along with subcutaneous delivery of both the fast-acting insulin analog lispro and glucagon (to imitate normal physiology) as directed by a computer algorithm. The algorithm responded only to BG concentrations and incorporated a pharmacokinetic model for lispro. Eleven subjects with type 1 diabetes and no endogenous insulin secretion were studied in 27-hour experiments, which included three carbohydrate-rich meals. In six subjects, the closed-loop system achieved a mean BG concentration of 140 mg/dl, which is below the mean BG concentration target of < or =154 mg/dl recommended by the American Diabetes Association. There were no instances of treatment-requiring hypoglycemia. Five other subjects exhibited hypoglycemia that required treatment; however, these individuals had slower lispro absorption kinetics than the six subjects that did not become hypoglycemic. The time-to-peak plasma lispro concentrations of subjects that exhibited hypoglycemia ranged from 71 to 191 min (mean, 117 +/- 48 min) versus 56 to 72 min (mean, 64 +/- 6 min) in the group that did not become hypoglycemic (aggregate mean of 84 min versus 31 min longer than the algorithm's assumption of 33 min, P = 0.07). In an additional set of experiments, adjustment of the algorithm's pharmacokinetic parameters (time-to-peak plasma lispro concentration set to 65 min) prevented hypoglycemia in both groups while achieving an aggregate mean BG concentration of 164 mg/dl. These results demonstrate the feasibility of safe BG control by a bihormonal artificial endocrine pancreas.

Indexed as

Drug Delivery SystemsPancreas, ArtificialAdultAgedBlood GlucoseDiabetes Mellitus, Type 1FemaleGlucagonHumansInsulinInsulin LisproMaleMiddle AgedYoung AdultBlood GlucoseGlucagonInsulinInsulin Lispro

Identifiers

PMID20393188
PMCPMC4242106

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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 OpenQuestion graph.