Evidence map›Paper›PMID 24931572›Full record

Trial reportThe New England journal of medicine2014

Outpatient glycemic control with a bionic pancreas in type 1 diabetes.

Steven J Russell, Firas H El-Khatib, Manasi Sinha, Kendra L Magyar, Katherine McKeon, Laura G Goergen, Courtney Balliro, Mallory A Hillard, David M Nathan, Edward R Damiano

3 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 242 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
242citing papers in PubMed, 4 pooled it
59.9field-weighted citation impact, top 1% 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.

NCT01762059 nacompletednot on this map

The Beacon Hill Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine Pancreas

TypeinterventionalSponsorMassachusetts General HospitalRan2013 to 2014Enrolled32ConditionsType 1 DiabetesArmsBi-homonal Bionic Pancreas, Usual care
NCT01833988 nacompletednot on this map

The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps

TypeinterventionalSponsorMassachusetts General HospitalRan2013 to 2014Enrolled32ConditionsType 1 DiabetesArmsBi-hormonal Bionic Pancreas, Usual Care
NCT04347590 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Impact of Continuous Glucose Monitoring on Cerebral Oxygenation in Preterm Infants (the Babyglucolight Trial)

TypeinterventionalSponsorUniversity Hospital PadovaRan2020 to 2025Enrolled60ConditionsInfant Development, Hypoglycemia Neonatal, Neurodevelopmental AbnormalityArmsUnblinded - CGM (Medtronic Guardian), Blinded - CGM (Medtronic Guardian)
3 · Its place in the literature

Who cites it

242 citing papers in PubMed, 4 syntheses or guidelines pooled it, 599 citations in OpenAlex.

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182 more citing papers are in PubMed but not listed here.

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 at 3 institutions in 1 country.

Steven J Russell *Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Firas H El-Khatib *Diabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Manasi SinhaDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Kendra L MagyarDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Katherine McKeonDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Laura G GoergenDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Courtney BalliroDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Mallory A HillardDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
David M NathanDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Edward R DamianoDiabetes Unit and Department of Medicine, Massachusetts General Hospital and Harvard Medical School (S.J.R., M.S., K.L.M, L.G.G., C.B., M.A.H., D.M.N.), and the Department of Biomedical Engineering, Boston University (F.H.E.-K., K.M., E.R.D.) - both in Boston.
Harvard University · USBoston University · USMassachusetts General Hospital · US

Funding

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
Translatioanl studies of a bionic pancreas for out-patient diabetes managementR01DK097657 · NIDDK · BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) · PI DAMIANO, EDWARD, RUSSELL, STEVEN J · 2013 to 2015
$2.5M
NIDDK NIH HHS R01 DK085633NIDDK NIH HHS R01DK085633NIDDK NIH HHS R01 DK097657NIDDK NIH HHS R01DK097657
6 · The paper itself

Abstract

backgroundThe safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions.

methodsIn two random-order, crossover studies with similar but distinct designs, we compared glycemic control with a wearable, bihormonal, automated, "bionic" pancreas (bionic-pancreas period) with glycemic control with an insulin pump (control period) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus. The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon.

resultsAmong the adults, the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter (7.7 mmol per liter), and the mean percentage of time with a low glucose level (<70 mg per deciliter [3.9 mmol per liter]) was 4.8%. After 1 day of automatic adaptation by the bionic pancreas, the mean (±SD) glucose level on continuous monitoring was lower than the mean level during the control period (133±13 vs. 159±30 mg per deciliter [7.4±0.7 vs. 8.8±1.7 mmol per liter], P<0.001) and the percentage of time with a low glucose reading was lower (4.1% vs. 7.3%, P=0.01). Among the adolescents, the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period (138±18 vs. 157±27 mg per deciliter [7.7±1.0 vs. 8.7±1.5 mmol per liter], P=0.004), but the percentage of time with a low plasma glucose reading was similar during the two periods (6.1% and 7.6%, respectively; P=0.23). The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period (one per 1.6 days vs. one per 0.8 days, P<0.001).

conclusionsAs compared with an insulin pump, a wearable, automated, bihormonal, bionic pancreas improved mean glycemic levels, with less frequent hypoglycemic episodes, among both adults and adolescents with type 1 diabetes mellitus. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01762059 and NCT01833988.).

Indexed as

Pancreas, ArtificialAdolescentAdultAgedBionicsBlood GlucoseChildCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansHypoglycemiaHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID24931572
PMCPMC4183762
OpenAlexW2158609480

What OpenQuestion holds

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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.