Evidence map›Paper›PMID 22923666›Full record

ArticleDiabetes care2012

Blood glucose control in type 1 diabetes with a bihormonal bionic endocrine pancreas.

Steven J Russell, Firas H El-Khatib, David M Nathan, Kendra L Magyar, John Jiang, Edward R Damiano

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03303196 (Bihormonal Bionic Pancreas for the Treatment of Diabetes Post-Pancreatectomy in Children With Congenital Hyperinsulinism - A Pilot Study), which is not on this map. Cited by 73 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing 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.

NCT03303196 nacompletednot on this mapstarted 2018, after this paper: background citation

Bihormonal Bionic Pancreas for the Treatment of Diabetes Post-Pancreatectomy in Children With Congenital Hyperinsulinism - A Pilot Study

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2018 to 2019Enrolled10ConditionsHyperinsulinism, Diabetes, Pancreatic Diseases, PancreatectomyArmsBihormonal Bionic Pancreas
3 · Its place in the literature

Who cites it

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

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  11. Home Use of an Artificial Beta Cell in Type 1 Diabetes.The New England journal of medicine · 2015
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  17. An integrated multivariable artificial pancreas control system.Journal of diabetes science and technology · 2014
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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Steven J RussellDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Firas H El-Khatib
David M Nathan
Kendra L Magyar
John Jiang
Edward R Damiano

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 BROWN, EMERY N · 1985 to 2008
$37.4M
Clinical trials of a closed-loop control system for type 1 diabetes managementR01DK085633 · NIDDK · BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) · PI DAMIANO, EDWARD · 2009 to 2012
$3.4M
NCRR NIH HHS M01 RR001066NCRR NIH HHS UL1 RR025758NIDDK NIH HHS R01 DK085633NIDDK NIH HHS R01-DK-085633
6 · The paper itself

Abstract

objectiveTo test whether safe and effective glycemic control could be achieved in type 1 diabetes using a bihormonal bionic endocrine pancreas driven by a continuous glucose monitor in experiments lasting more than two days and including six high-carbohydrate meals and exercise as challenges to glycemic control. RESEARCH DESIGN AND

methodsSix subjects with type 1 diabetes and no endogenous insulin secretion participated in two 51-h experiments. Blood glucose was managed with a bionic endocrine pancreas controlling subcutaneous delivery of insulin and glucagon with insulin pumps. A partial meal-priming bolus of insulin (0.035 units/kg/meal, then 0.05 units/kg/meal in repeat experiments) was administered at the beginning of each meal (on average 78 ± 12 g of carbohydrates per meal were consumed). Plasma glucose (PG) control was evaluated with a reference quality measurement on venous blood every 15 min.

resultsThe overall mean PG was 158 mg/dL, with 68% of PG values in the range of 70-180 mg/dL. There were no significant differences in mean PG between larger and smaller meal-priming bolus experiments. Hypoglycemia (PG <70 mg/dL) was rare, with eight incidents during 576 h of closed-loop control (0.7% of total time). During 192 h of nighttime control, mean PG was 123 mg/dL, with 93% of PG values in the range of 70-180 mg/dL and only one episode of mild hypoglycemia (minimum PG 62 mg/dL).

conclusionsA bihormonal bionic endocrine pancreas achieved excellent glycemic control with minimal hypoglycemia over the course of two days of continuous use despite high-carbohydrate meals and exercise. A trial testing a wearable version of the system under free-living conditions is justified.

Indexed as

AdolescentAdultAgedBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleGlucagonHumansHypoglycemiaInsulinIslets of LangerhansMaleMiddle AgedYoung AdultBlood GlucoseGlucagonInsulin

Identifiers

PMID22923666
PMCPMC3476884

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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 OpenQuestion graph.