Evidence map›Paper›PMID 32037699›Full record

Observational studyDiabetes, obesity & metabolism2020

Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.

Concetta Irace, Antonio Cutruzzolà, Annamaria Nuzzi, Roberta Assaloni, Barbara Brunato, Dario Pitocco, Linda Tartaglione, Sergio Di Molfetta, Angelo Cignarelli, Luigi Laviola and 5 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04160156 (Clinical Use of the Long-term Implantable Sensor Improves Glycated Hemoglobin and Time in Range in Patients With Type 1 Diabetes), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.4field-weighted citation impact, top 10% 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.

NCT04160156 completednot on this map

Clinical Use of the Long-term Implantable Sensor Improves Glycated Hemoglobin and Time in Range in Patients With Type 1 Diabetes

TypeobservationalSponsorUniversity Magna GraeciaRan2018 to 2019Enrolled100ConditionsDiabetes Mellitus, Type 1ArmsLong term sensor
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 27 citations in OpenAlex.

  1. Observational
  2. Review
  3. Review
  4. Article
  5. Review
  6. Expert Consensus Recommendations on Time in Range for Monitoring Glucose Levels in People with Diabetes: An Indian Perspective.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  7. Review
  8. Article
  9. Article
  10. Observational
  11. Observational
  12. Review
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

15 authors at 8 institutions in 2 countries.

Concetta IraceDepartment of Health Science, University Magna Graecia, Catanzaro, Italy.
Antonio CutruzzolàDepartment of Clinical and Experimental Medicine, University Magna Graecia, Catanzaro, Italy.
Annamaria NuzziDiabetologia ed Endocrinologia ASL CN2, Alba Bra, Italy.
Roberta AssaloniSSD di Diabetologia, AAS2 Bassa Friulana-Isontina, Italy.
Barbara BrunatoSSD di Diabetologia, AAS2 Bassa Friulana-Isontina, Italy.
Dario PitoccoUOSA Diabetologia, Fondazione IRCCS, University Agostino Gemelli, Rome, Italy.
Linda TartaglioneUOSA Diabetologia, Fondazione IRCCS, University Agostino Gemelli, Rome, Italy.
Sergio Di MolfettaMedicina Interna, Endocrinologia, Andrologia e Malattie Metaboliche, D.E.T.O., Università degli Studi di Bari "Aldo Moro", Bari, Italy.
Angelo CignarelliMedicina Interna, Endocrinologia, Andrologia e Malattie Metaboliche, D.E.T.O., Università degli Studi di Bari "Aldo Moro", Bari, Italy.ORCID 0000-0001-6477-9031
Luigi LaviolaMedicina Interna, Endocrinologia, Andrologia e Malattie Metaboliche, D.E.T.O., Università degli Studi di Bari "Aldo Moro", Bari, Italy.
Giuseppe CitroUOSD Diabetologia ed Endocrinologia ASP, Potenza, Italy.
Elisabetta LovatiClinica Medica I, Fondazione IRCCS, University San Matteo, Pavia, Italy.
Agostino GnassoDepartment of Clinical and Experimental Medicine, University Magna Graecia, Catanzaro, Italy.
Katherine S TwedenSenseonics Inc., Germantown, Maryland, US.ORCID 0000-0003-0942-4865
Francine R KaufmanSenseonics Inc., Germantown, Maryland, US.
Magna Graecia University · ITUniversity of Bari Aldo Moro · ITAgostino Gemelli University Polyclinic · ITScuola Internazionale Superiore di Studi Avanzati · ITSenseonics (United States) · USAzienda Sanitaria Locale CN2 · ITUniversity of Basilicata · ITUniversity of Pavia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis real-world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180-day Eversense CGM System (Eversense) in patients with type 1 diabetes. MATERIALS AND

methodsThis was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes-care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70-180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery.

resultsOne-hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty-six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (-0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM-naïve patients achieved the greatest reduction in HbA1c (-0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear.

conclusionsReal-world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).

Indexed as

Diabetes Mellitus, Type 1AdolescentAdultBlood GlucoseBlood Glucose Self-MonitoringGlycated HemoglobinHumansInsulinItalyMiddle AgedProspective StudiesYoung AdultBlood GlucoseGlycated HemoglobinInsulin

Identifiers

PMID32037699
PMCPMC7317779
OpenAlexW3004916333

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.