International Consensus on Use of Continuous Glucose Monitoring

Danne, Thomas; Nimri, Revital; Battelino, Tadej; Bergenstal, Richard M.; Close, Kelly L; DeVries, J. Hans; Garg, Satish; Heinemann, Lutz; Hirsch, Irl; Amiel, Stephanie A.; Beck, Roy; Bosi, Emanuele; Buckingham, Bruce N.; Cobelli, Claudio; Dassau, Eyal; Doyle, Francis J.; Heller, Simon; Hovorka, Roman; Jia, Weiping; Jones, Tim; Kordonouri, Olga; Kovatchev, Boris P.; Kowalski, Aaron; Laffel, Lori MB; Maahs, David M; Murphy, Helen R.; Nørgaard, Kirsten; Parkin, Christopher G; Renard, Eric; Saboo, Banshi; Scharf, Mauro; Tamborlane, William V.; Weinzimer, Stuart A.; Phillip, Moshe

doi:10.2337/dc17-1600

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International Consensus on Use of Continuous Glucose Monitoring

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Author(s): Thomas Danne ¹ , Revital Nimri ² , Tadej Battelino ³ , Richard M. Bergenstal ⁴ , Kelly L. Close ⁵ , J. Hans DeVries ⁶ , Satish Garg ⁷ , Lutz Heinemann ⁸ , Irl Hirsch ⁹ , Stephanie A. Amiel ¹⁰ , Roy Beck ¹¹ , Emanuele Bosi ¹² , Bruce Buckingham ¹³ , Claudio Cobelli ¹⁴ , Eyal Dassau ¹⁵ , Francis J. Doyle III ¹⁵ , Simon Heller ¹⁶ , Roman Hovorka ¹⁷ , Weiping Jia ¹⁸ , Tim Jones ¹⁹ , Olga Kordonouri ¹ , Boris Kovatchev ²⁰ , Aaron Kowalski ²¹ , Lori Laffel ²² , David Maahs ¹³ , Helen R. Murphy ²³ , Kirsten Nørgaard ²⁴ , Christopher G. Parkin ²⁵ , Eric Renard ²⁶ , Banshi Saboo ²⁷ , Mauro Scharf ²⁸ , William V. Tamborlane ²⁹ , Stuart A. Weinzimer ²⁹ , Moshe Phillip ²

Publication date (Electronic): 10 November 2017

Journal: Diabetes Care

Publisher: American Diabetes Association

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Abstract

Measurement of glycated hemoglobin (HbA _1c) has been the traditional method for assessing glycemic control. However, it does not reflect intra- and interday glycemic excursions that may lead to acute events (such as hypoglycemia) or postprandial hyperglycemia, which have been linked to both microvascular and macrovascular complications. Continuous glucose monitoring (CGM), either from real-time use (rtCGM) or intermittently viewed (iCGM), addresses many of the limitations inherent in HbA _1c testing and self-monitoring of blood glucose. Although both provide the means to move beyond the HbA _1c measurement as the sole marker of glycemic control, standardized metrics for analyzing CGM data are lacking. Moreover, clear criteria for matching people with diabetes to the most appropriate glucose monitoring methodologies, as well as standardized advice about how best to use the new information they provide, have yet to be established. In February 2017, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address these issues. This article summarizes the ATTD consensus recommendations and represents the current understanding of how CGM results can affect outcomes.

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Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia.

A Gold, K M Macleod, B. Frier (1994)

To determine the frequency of hypoglycemia in patients with type I diabetes and impaired awareness of hypoglycemia by prospective assessment. A prospective study was undertaken for 12 months in 60 patients with type I diabetes: 29 had impaired awareness of hypoglycemia and 31 retained normal awareness of hypoglycemia. The two groups of patients were matched for age, age at onset of diabetes, duration of diabetes, and glycemic control. Episodes of severe hypoglycemia were recorded within 24 h of the event and verified where possible by witnesses. During the 12 months, 19 (66%) of the patients with impaired awareness had one or more episodes of severe hypoglycemia with an overall incidence of 2.8 episodes.patient-1.year-1. By comparison, 8 (26%) of the patients with normal awareness experienced severe hypoglycemia (P < 0.01) with an annual incidence of 0.5 episode.patient-1.year-1 (P < 0.001). Severe hypoglycemia occurred at different times of the day in the two groups: patients with impaired awareness experienced a greater proportion of episodes during the evening (P = 0.03), and patients with normal awareness experienced a greater proportion in the early morning (P = 0.05). An assessment of fear of hypoglycemia revealed that patients with impaired awareness of hypoglycemia worried more about hypoglycemia than did patients with normal awareness (P = 0.008), but did not modify their behavior accordingly. This prospective evaluation demonstrated that impaired awareness of hypoglycemia predisposes to a sixfold increase in the frequency of severe hypoglycemia, much of which occurred at home during waking hours.

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Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

Thomas Haak, Hélène Hanaire, Ramzi A Ajjan … (2016)

Introduction Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG). Methods This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction. Results Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [−5.7 ± 0.96 mmol/mol (−0.53 ± 0.09%) and −2.2 ± 1.31 mmol/mol (−0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild). Conclusion Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG. Trial registration ClinicalTrials.gov identifier: NCT02082184. Funding Abbott Diabetes Care. Electronic supplementary material The online version of this article (doi:10.1007/s13300-016-0223-6) contains supplementary material, which is available to authorized users.

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Introduction.

(2017)

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Author and article information

Journal

Journal ID (nlm-ta): Diabetes Care

Journal ID (iso-abbrev): Diabetes Care

Journal ID (hwp): diacare

Journal ID (pmc): dcare

Journal ID (publisher-id): Diabetes Care

Title: Diabetes Care

Publisher: American Diabetes Association

ISSN (Print): 0149-5992

ISSN (Electronic): 1935-5548

Publication date (Print): December 2017

Publication date (Electronic): 10 November 2017

Volume: 40

Issue: 12

Pages: 1631-1640

Affiliations

[1] ¹Diabetes Centre for Children and Adolescents, Children’s and Youth Hospital “Auf Der Bult,” Hannover, Germany

[2] ²The Myrtle and Henry Hirsch National Center for Childhood Diabetes, The Jesse and Sara Lea Shafer Institute of Endocrinology and Diabetes, Schneider Children’s Medical Center of Israel, Petah Tikva, Israel

[3] ³Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children’s Hospital, Ljubljana University Medical Centre, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

[4] ⁴International Diabetes Center at Park Nicollet, Minneapolis, MN

[5] ⁵Close Concerns, San Francisco, CA

[6] ⁶Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands

[7] ⁷University of Colorado Denver and Barbara Davis Center for Diabetes, Aurora, CO

[8] ⁸Science & Co, Düsseldorf, Germany

[9] ⁹Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington School of Medicine, Seattle, WA

[10] ¹⁰Diabetes Research Group, King's College London, London, U.K.

[11] ¹¹Jaeb Center for Health Research, Tampa, FL

[12] ¹²Diabetes Research Institute, University “Vita-Salute” San Raffaele, Milan, Italy

[13] ¹³Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University Medical Center, Stanford, CA

[14] ¹⁴Department of Information Engineering, University of Padova, Padova, Italy

[15] ¹⁵John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA

[16] ¹⁶Academic Unit of Diabetes, Endocrinology & Metabolism, The University of Sheffield, Sheffield, U.K.

[17] ¹⁷Wellcome Trust-MRC Institute of Metabolic Science and Department of Paediatrics, University of Cambridge, Cambridge, U.K.

[18] ¹⁸Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes Mellitus, Shanghai Clinical Center of Diabetes, Shanghai, China

[19] ¹⁹Telethon Kids Institute and School of Paediatrics and Child Health, The University of Western Australia, and Department of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Australia

[20] ²⁰Center for Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA

[21] ²¹JDRF, New York, NY

[22] ²²Pediatric, Adolescent and Young Adult Section and Section on Clinical, Behavioral and Outcomes Research, Joslin Diabetes Center, Harvard Medical School, Boston, MA

[23] ²³Norwich Medical School, University of East Anglia, Norwich, U.K.

[24] ²⁴Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark

[25] ²⁵CGParkin Communications, Boulder City, NV

[26] ²⁶Department of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, and Institute of Functional Genomics, University of Montpellier, and INSERM Clinical Investigation Centre, Montpellier, France

[27] ²⁷DiaCare, Ahmedabad, Gujarat, India

[28] ²⁸Centro de Diabetes Curitiba and Division of Pediatric Endocrinology, Hospital Nossa Senhora das Graças, Curitiba, Brazil

[29] ²⁹Department of Pediatrics, Yale School of Medicine, New Haven, CT

Author notes

Corresponding author: Thomas Danne, danne@ 123456hka.de .

Author information

Thomas Danne http://orcid.org/0000-0003-0773-6961

Tadej Battelino http://orcid.org/0000-0002-0273-4732

J. Hans DeVries http://orcid.org/0000-0001-9196-9906

Roy Beck http://orcid.org/0000-0002-5194-8446

Claudio Cobelli http://orcid.org/0000-0002-0169-6682

Eyal Dassau http://orcid.org/0000-0001-5333-6892

Francis J. Doyle III http://orcid.org/0000-0002-3293-9114

Simon Heller http://orcid.org/0000-0002-2425-9565

Tim Jones http://orcid.org/0000-0002-7989-1998

Aaron Kowalski http://orcid.org/0000-0002-0979-5343

Lori Laffel http://orcid.org/0000-0002-9675-3001

Christopher G. Parkin http://orcid.org/0000-0001-6838-5355

Article

Publisher ID: 1600

DOI: 10.2337/dc17-1600

PMC ID: 6467165

PubMed ID: 29162583

SO-VID: 44fba275-e1ee-4b0c-89ca-55681d8303ec

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Funded by: Advanced Technologies and Treatments for Diabetes (ATTD) Congress, DOI http://dx.doi.org/;

International Consensus on Use of Continuous Glucose Monitoring

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Journal of the ASEAN Federation of Endocrine Societies

Most cited references 60

Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia.

Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

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