Evidence map›Paper›PMID 32100192›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020

InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design.

Tadej Battelino, Zsolt Bosnyak, Thomas Danne, Bhaswati Mukherjee, Steve Edelman, Valerie Pilorget, Pratik Choudhary, Eric Renard, Richard Bergenstal

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04075513 (A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT04075513 phase4completednot on this map

A 12-week Randomized, Controlled Trial to Compare TOUJEO® and TRESIBA® in Terms of Glucose Values in Target Range and Variability During Continuous Glucose Monitoring in Patients With Type 1 Diabetes Mellitus

TypeinterventionalSponsorSanofiRan2019 to 2021Enrolled343ConditionsType 1 Diabetes MellitusArmsInsulin glargine, 300 U/ml, Insulin degludec, 100U/ml, Background therapy: Rapid acting insulin analogs
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  2. Trial
  3. Review
  4. Insulin Therapy for the Management of Diabetes Mellitus: A Narrative Review of Innovative Treatment Strategies.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  5. Correlation Between Time in Range and HbA1c in People with Type 2 Diabetes on Basal Insulin: Post Hoc Analysis of the SWITCH PRO Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  6. Review
  7. Review
  8. Article
  9. Time in Range as a Research Outcome Measure.Diabetes spectrum : a publication of the American Diabetes Association · 2021
    Article
  10. Individualizing Time-in-Range Goals in Management of Diabetes Mellitus and Role of Insulin: Clinical Insights From a Multinational Panel.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 5 countries.

Tadej BattelinoUMC-University Children's Hospital, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. tadej.battelino@mf.uni-lj.si.
Zsolt BosnyakSanofi S.A., Paris, France.
Thomas DanneDiabetes Centre for Children and Adolescents, Children's and Youth Hospital "Auf Der Bult", Hannover, Germany.
Bhaswati MukherjeeSanofi S.A., Paris, France.
Steve EdelmanUniversity of California, San Diego, CA, USA.
Valerie PilorgetSanofi S.A., Paris, France.
Pratik ChoudharyKing's College Hospital NHS Foundation Trust, London, UK.
Eric RenardDepartment of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, University of Montpellier, Montpellier, France.
Richard BergenstalInternational Diabetes Center at Park Nicollet, Minneapolis, USA.
Sanofi (France) · FRInserm · FRKinderkrankenhaus auf der Bult · DEKing's College London · GBLjubljana University Medical Centre · SIPark Nicollet Clinic · USUniversity of California, San Diego · US

Funding

Home Use of MD-Logic Automated Insulin Delivery System: Safety and EfficacyUC4DK108611 · NIDDK · HEALTHPARTNERS INSTITUTE · PI BERGENSTAL, RICHARD MAURITZ, PHILLIP, MOSHE · 2015 to 2016
$8.9M
NIDDK NIH HHS UC4 DK108611Sanofi, Paris, France NCT04075513
6 · The paper itself

Abstract

introductionSuboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro- and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need.

methodsInRange is a multicentre, randomised, active-controlled, parallel-group, 12-week, open-label, phase 4, comparative study. Adults with T1D will be randomised to receive once-daily Gla-300 or IDeg-100 by subcutaneous injection in the morning. Following an 8-week titration period, CGM data will be collected over 20 consecutive days. PLANNED OUTCOMES: The primary objective is to demonstrate that Gla-300 is noninferior to IDeg-100 in terms of glycaemic control [time-in-range ≥ 70 to ≤ 180 mg/dL (≥ 3.9 to ≤ 10 mmol/L)] and variability, as assessed using CGM, in adults with T1D. The results are expected to help confirm the utility of CGM in clinical practice in this population and provide insight into its application as an outcome measure in clinical practice.

trial registrationNCT04075513.

Indexed as

Continuous glucose monitoringFasting plasma glucoseGlucose variabilityGlycated haemoglobinInsulinInsulin degludecInsulin glargineSelf-monitoring of plasma glucoseTime-in-rangeType 1 diabetes

Identifiers

PMID32100192
PMCPMC7136362
OpenAlexW3007217485

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.