Evidence map›Paper›PMID 26880389›Full record

Trial reportJournal of diabetes science and technology2016

Hybrid Closed-Loop Insulin Delivery in Type 1 Diabetes During Supervised Outpatient Conditions.

Benyamin Grosman, Jacob Ilany, Anirban Roy, Natalie Kurtz, Di Wu, Neha Parikh, Gayane Voskanyan, Noa Konvalina, Chrystaleni Mylonas, Rebecca Gottlieb and 2 more

Abstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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

18 citing papers in PubMed.

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  16. A Review of the Current Challenges Associated with the Development of an Artificial Pancreas by a Double Subcutaneous Approach.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017
    Review
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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

12 authors.

Benyamin GrosmanMedtronic MiniMed, Northridge, CA, USA benyamin.grosman@medtronic.com.
Jacob IlanyInstitute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
Anirban RoyMedtronic MiniMed, Northridge, CA, USA.
Natalie KurtzMedtronic MiniMed, Northridge, CA, USA.
Di WuMedtronic MiniMed, Northridge, CA, USA.
Neha ParikhMedtronic MiniMed, Northridge, CA, USA.
Gayane VoskanyanMedtronic MiniMed, Northridge, CA, USA.
Noa KonvalinaInstitute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
Chrystaleni MylonasInstitute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.
Rebecca GottliebMedtronic MiniMed, Northridge, CA, USA.
Francine KaufmanMedtronic MiniMed, Northridge, CA, USA.
Ohad CohenInstitute of Endocrinology, Sheba Medical Center, Tel-Hashomer, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEfficacy and safety of the Medtronic Hybrid Closed-Loop (HCL) system were tested in subjects with type 1 diabetes in a supervised outpatient setting.

methodsThe HCL system is a prototype research platform that includes a sensor-augmented insulin pump in communication with a control algorithm housed on an Android-based cellular device. Nine subjects with type 1 diabetes (5 female, mean age 53.3 years, mean A1C 7.2%) underwent 9 studies totaling 571 hours of closed-loop control using either default or personalized parameters. The system required meal announcements with estimates of carbohydrate (CHO) intake that were based on metabolic kitchen quantification (MK), dietician estimates (D), or subject estimates (Control). Postprandial glycemia was compared for MK, D, and Control meals.

resultsThe overall sensor glucose mean was 145 ± 43, the overall percentage time in the range 70-180 mg/dL was 80%, the overall percentage time <70 mg/dL was 0.79%. Compared to intervals of default parameter use (225 hours), intervals of personalized parameter use (346 hours), sensor glucose mean was 158 ± 49 and 137 ± 37 mg/dL (P < .001), respectively, and included more time in range (87% vs 68%) and less time below range (0.54% vs 1.18%). Most subjects underestimated the CHO content of meals, but postprandial glycemia was not significantly different between MK and matched Control meals (P = .16) or between D and matched Control meals (P = .76). There were no episodes of severe hypoglycemia.

conclusionsThe HCL system was efficacious and safe during this study. Personally adapted HCL parameters were associated with more time in range and less time below range than default parameters. Accurate estimates of meal CHO did not contribute to improved postprandial glycemia.

Indexed as

Insulin Infusion SystemsPancreas, ArtificialAdultAlgorithmsBlood GlucoseBlood Glucose Self-MonitoringCell PhoneDiabetes Mellitus, Type 1FemaleHumansHypoglycemic AgentsInsulinMaleMiddle AgedOutpatientsTelemedicineBlood GlucoseHypoglycemic AgentsInsulinartificial pancreasdiabeteshuman trialsinsulin pump therapy

Identifiers

PMID26880389
PMCPMC5038540

What Socratic holds

Textmetadata
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 Socratic graph.