Flash glucose monitoring: objective, not self-referential, outcomes are needed. Reply to Warren RE [letter]

Flash glucose monitoring: objective, not self-referential, outcomes are needed. Reply to Warren... Diabetologia (2018) 61:1879–1880 https://doi.org/10.1007/s00125-018-4652-9 LETTER Flash glucose monitoring: objective, not self-referential, outcomes are needed. Reply to Warren RE [letter] 1 1 2 3 4 Jan Bolinder & Per Oskarsson & Ramiro Antuna & Petronella Geelhoed-Duijvestijn & Jens Krӧger & 5,6 Raimund Weitgasser Received: 16 April 2018 / Accepted: 19 April 2018 / Published online: 2 June 2018 The Author(s) 2018 . . . Keywords Clinical diabetes Devices Hypoglycaemia Insulin therapy Abbreviation (SMBG). The main glycaemic outcome measures with this IMPACT Novel Glucose-Sensing Technology type of study design require sensor glucose results to be and Hypoglycaemia in Type 1 Diabetes: visible to the intervention group but blinded in the control a Multicentre Non-masked group. Warren reiterates a valid point regarding using the Randomised Controlled Trial same device for the treatment and assessment of an out- come. This was indeed noted in our original study article [3]; however the general consensus is that there is no practical alternative to this approach [4]. To the Editor: We thank Dr Roderick Warren for his letter With regard to the reliability of the sensor recordings, the [1] regarding our subgroup analysis of the Novel Glucose- accuracy of FreeStyle Libre in the low glucose range (capillary Sensing Technology and Hypoglycaemia in Type 1 reference <4.4 mmol/l [80 mg/dl]), calculated from raw data Diabetes: a Multicentre, Non-masked, Randomised collected by Bailey et al [5] had a mean bias of 0.2 mmol/l Controlled Trial (IMPACT; NCT02232698) [2]. In line (2.9 mg/dl) and a mean absolute difference (MAD) of with the accepted practice in continuous glucose monitor- 0.6 mmol/l (10.4 mg/dl). In the IMPACT study baseline phase, ing studies, the trial was designed to compare individuals mean bias was 0.0 mmol/l (0.3 mg/dl) and MAD 0.6 mmol/l using the FreeStyle Libre system (Abbott Diabetes Care, (10.6 mg/dl) for capillary glucose <4.4 mmol/l. A recent head Witney, UK) for glucose monitoring with those using the to head study supports the accuracy of FreeStyle Libre vs conventional technique, self-monitoring blood glucose two continuous glucose monitoring (CGM) devices in the hypoglycaemic range [6]. Warren states that studies like this require externally valid outcomes such as HbA or severe hypoglycaemia but does 1c * Jan Bolinder not suggest a viable alternative outcome that could have jan.bolinder@ki.se been utilised for this study. HbA did not increase in the 1c intervention group, which should be viewed positively in the Department of Medicine, Karolinska University Hospital Huddinge, context of a study population with extremely well-controlled Karolinska Institute, 141 86 Stockholm, Sweden blood glucose, reduced hypoglycaemia and a final mean Department of Medicine, Clinica Diabetologica, Gijon, Spain HbA of 53.0 mmol/mol. Severe hypoglycaemia is indeed 1c very rare, with six instances reported in the treatment phase Department of Internal Medicine, Haaglanden Medisch Centrum, DenHaag, theNetherlands of this study (two in the intervention group and four in the control group), and therefore much larger numbers of pa- Department of Diabetes, Zentrum für Diabetologie Hamburg Bergedorf, Hamburg, Germany tients would need to be studied over long periods to detect a clinically relevant improvement. Notably, there was a 30% Department of Medicine, Wehrle-Diakonissen Hospital, Salzburg, Austria reduction in the frequency of participant-reported symptom- atic hypoglycaemia in the final 2 weeks (p =0.0063). Hence, 1st Department of Medicine, University Hospital of Paracelsus, in our view, this similar reduction in symptomatic Medical Private University, Salzburg, Austria 1880 Diabetologia (2018) 61:1879–1880 distribution, and reproduction in any medium, provided you give appro- hypoglycaemia is corroborating evidence for the validity of priate credit to the original author(s) and the source, provide a link to the the primary outcome result. Creative Commons license, and indicate if changes were made. Acknowledgements The authors thank Z. Welsh (Statistics, Abbott Diabetes Care, Witney, UK). References Funding This study was funded by Abbott Diabetes Care and by grants from the Swedish Diabetes Association and the Diabetes Research 1. Warren RE (2018) Flash glucose monitoring: objective, not self-ref- Program at Karolinska Institutet. erential, outcomes are needed. Diabetologia. https://doi.org/10.1007/ s00125-018-4608-0 Duality of interest JB has received honoraria for consulting or lecture fees 2. Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Kroger J, from Abbott Diabetes Care, AstraZeneca, Insulet Corporation, Integrity Weitgasser R, Bolinder J (2018) Impact of flash glucose monitoring Applications, Novo Nordisk, and Sanofi-Aventis. RA has received hono- on hypoglycaemia in adults with type 1 diabetes managed with mul- raria for lecture fees for Abbott Diabetes Care. PG-D has received lecture tiple daily injection therapy: a pre-specified subgroup analysis of the honoraria from Abbott Diabetes Care and Medtronic and served on advi- IMPACT randomised controlled trial. Diabetologia 61:539–550 sory boards for Medtronic. JK has received personal fees from Abbot 3. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser Diabetes Care, personal fees from Abbott Diabetes Care during the conduct R (2016) Novel glucose-sensing technology and hypoglycemia in of this study; personal fees from Lilly, Novo Nordisk, Berlin Chemie, type 1 diabetes: a multicentre, non-masked, randomised controlled Medtronic, Sanofi, MSD and AstraZeneca. RW received lecture honoraria trial. Lancet 388:2254–2263 and serves on advisory boards for Abbott Diabetes Care, Boehringer- 4. Maahs DM, Buckingham B, Castle J et al (2016) Outcome measures Ingelheim, Eli Lilly, Merck Sharp & Dohme, Novo Nordisk, Roche for artificial pancreas clinical trials: a consensus report. Diabetes Diabetes Care, Sanofi and Servier; and has received unrestricted study Care 39:1175–1179 grants from Eli Lilly, Novo Nordisk, and Sanofi. PO declares that there is 5. Bailey T, Bode BW, Christiansen MP et al (2015) The performance no duality of interest associated with his contribution to this manuscript. and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technol Ther 17:787–794 Contribution statement JB wrote the first draft of the response letter and 6. Aberer F, Hajnsek M, Rumpler M et al (2017) Evaluation of subcutane- worked collaboratively with the co-authors to discuss and review this ous glucose monitoring systems under routine environmental conditions response. All authors reviewed and approved the final draft and approved in patients with type 1 diabetes. Diabetes Obes Metab 19:1051–1055 the submission. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http:// creativecommons.org/licenses/by/4.0/), which permits unrestricted use, http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Diabetologia Springer Journals

Flash glucose monitoring: objective, not self-referential, outcomes are needed. Reply to Warren RE [letter]

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Springer Journals
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Copyright © 2018 by The Author(s)
Subject
Medicine & Public Health; Internal Medicine; Metabolic Diseases; Human Physiology
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0012-186X
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1432-0428
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10.1007/s00125-018-4652-9
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Abstract

Diabetologia (2018) 61:1879–1880 https://doi.org/10.1007/s00125-018-4652-9 LETTER Flash glucose monitoring: objective, not self-referential, outcomes are needed. Reply to Warren RE [letter] 1 1 2 3 4 Jan Bolinder & Per Oskarsson & Ramiro Antuna & Petronella Geelhoed-Duijvestijn & Jens Krӧger & 5,6 Raimund Weitgasser Received: 16 April 2018 / Accepted: 19 April 2018 / Published online: 2 June 2018 The Author(s) 2018 . . . Keywords Clinical diabetes Devices Hypoglycaemia Insulin therapy Abbreviation (SMBG). The main glycaemic outcome measures with this IMPACT Novel Glucose-Sensing Technology type of study design require sensor glucose results to be and Hypoglycaemia in Type 1 Diabetes: visible to the intervention group but blinded in the control a Multicentre Non-masked group. Warren reiterates a valid point regarding using the Randomised Controlled Trial same device for the treatment and assessment of an out- come. This was indeed noted in our original study article [3]; however the general consensus is that there is no practical alternative to this approach [4]. To the Editor: We thank Dr Roderick Warren for his letter With regard to the reliability of the sensor recordings, the [1] regarding our subgroup analysis of the Novel Glucose- accuracy of FreeStyle Libre in the low glucose range (capillary Sensing Technology and Hypoglycaemia in Type 1 reference <4.4 mmol/l [80 mg/dl]), calculated from raw data Diabetes: a Multicentre, Non-masked, Randomised collected by Bailey et al [5] had a mean bias of 0.2 mmol/l Controlled Trial (IMPACT; NCT02232698) [2]. In line (2.9 mg/dl) and a mean absolute difference (MAD) of with the accepted practice in continuous glucose monitor- 0.6 mmol/l (10.4 mg/dl). In the IMPACT study baseline phase, ing studies, the trial was designed to compare individuals mean bias was 0.0 mmol/l (0.3 mg/dl) and MAD 0.6 mmol/l using the FreeStyle Libre system (Abbott Diabetes Care, (10.6 mg/dl) for capillary glucose <4.4 mmol/l. A recent head Witney, UK) for glucose monitoring with those using the to head study supports the accuracy of FreeStyle Libre vs conventional technique, self-monitoring blood glucose two continuous glucose monitoring (CGM) devices in the hypoglycaemic range [6]. Warren states that studies like this require externally valid outcomes such as HbA or severe hypoglycaemia but does 1c * Jan Bolinder not suggest a viable alternative outcome that could have jan.bolinder@ki.se been utilised for this study. HbA did not increase in the 1c intervention group, which should be viewed positively in the Department of Medicine, Karolinska University Hospital Huddinge, context of a study population with extremely well-controlled Karolinska Institute, 141 86 Stockholm, Sweden blood glucose, reduced hypoglycaemia and a final mean Department of Medicine, Clinica Diabetologica, Gijon, Spain HbA of 53.0 mmol/mol. Severe hypoglycaemia is indeed 1c very rare, with six instances reported in the treatment phase Department of Internal Medicine, Haaglanden Medisch Centrum, DenHaag, theNetherlands of this study (two in the intervention group and four in the control group), and therefore much larger numbers of pa- Department of Diabetes, Zentrum für Diabetologie Hamburg Bergedorf, Hamburg, Germany tients would need to be studied over long periods to detect a clinically relevant improvement. Notably, there was a 30% Department of Medicine, Wehrle-Diakonissen Hospital, Salzburg, Austria reduction in the frequency of participant-reported symptom- atic hypoglycaemia in the final 2 weeks (p =0.0063). Hence, 1st Department of Medicine, University Hospital of Paracelsus, in our view, this similar reduction in symptomatic Medical Private University, Salzburg, Austria 1880 Diabetologia (2018) 61:1879–1880 distribution, and reproduction in any medium, provided you give appro- hypoglycaemia is corroborating evidence for the validity of priate credit to the original author(s) and the source, provide a link to the the primary outcome result. Creative Commons license, and indicate if changes were made. Acknowledgements The authors thank Z. Welsh (Statistics, Abbott Diabetes Care, Witney, UK). References Funding This study was funded by Abbott Diabetes Care and by grants from the Swedish Diabetes Association and the Diabetes Research 1. Warren RE (2018) Flash glucose monitoring: objective, not self-ref- Program at Karolinska Institutet. erential, outcomes are needed. Diabetologia. https://doi.org/10.1007/ s00125-018-4608-0 Duality of interest JB has received honoraria for consulting or lecture fees 2. Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Kroger J, from Abbott Diabetes Care, AstraZeneca, Insulet Corporation, Integrity Weitgasser R, Bolinder J (2018) Impact of flash glucose monitoring Applications, Novo Nordisk, and Sanofi-Aventis. RA has received hono- on hypoglycaemia in adults with type 1 diabetes managed with mul- raria for lecture fees for Abbott Diabetes Care. PG-D has received lecture tiple daily injection therapy: a pre-specified subgroup analysis of the honoraria from Abbott Diabetes Care and Medtronic and served on advi- IMPACT randomised controlled trial. Diabetologia 61:539–550 sory boards for Medtronic. JK has received personal fees from Abbot 3. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser Diabetes Care, personal fees from Abbott Diabetes Care during the conduct R (2016) Novel glucose-sensing technology and hypoglycemia in of this study; personal fees from Lilly, Novo Nordisk, Berlin Chemie, type 1 diabetes: a multicentre, non-masked, randomised controlled Medtronic, Sanofi, MSD and AstraZeneca. RW received lecture honoraria trial. Lancet 388:2254–2263 and serves on advisory boards for Abbott Diabetes Care, Boehringer- 4. Maahs DM, Buckingham B, Castle J et al (2016) Outcome measures Ingelheim, Eli Lilly, Merck Sharp & Dohme, Novo Nordisk, Roche for artificial pancreas clinical trials: a consensus report. Diabetes Diabetes Care, Sanofi and Servier; and has received unrestricted study Care 39:1175–1179 grants from Eli Lilly, Novo Nordisk, and Sanofi. PO declares that there is 5. Bailey T, Bode BW, Christiansen MP et al (2015) The performance no duality of interest associated with his contribution to this manuscript. and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technol Ther 17:787–794 Contribution statement JB wrote the first draft of the response letter and 6. Aberer F, Hajnsek M, Rumpler M et al (2017) Evaluation of subcutane- worked collaboratively with the co-authors to discuss and review this ous glucose monitoring systems under routine environmental conditions response. All authors reviewed and approved the final draft and approved in patients with type 1 diabetes. Diabetes Obes Metab 19:1051–1055 the submission. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http:// creativecommons.org/licenses/by/4.0/), which permits unrestricted use,

Journal

DiabetologiaSpringer Journals

Published: Jun 2, 2018

References

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