The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial

Ulrik Pedersen-Bjergaard; Peter L. Kristensen; Henning Beck-Nielsen; Kirsten Nørgaard; Hans Perrild; Jens S. Christiansen; Tonny Jensen; Hans Henrik Parving; Birger Thorsteinsson; Lise Tarnow

doi:10.1016/j.diabres.2016.11.003

The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial

Ulrik Pedersen-Bjergaard^*, Peter L. Kristensen, Henning Beck-Nielsen, Kirsten Nørgaard, Hans Perrild, Jens S. Christiansen, Tonny Jensen, Hans Henrik Parving, Birger Thorsteinsson, Lise Tarnow

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

1 Citationer (Scopus)

Abstract

Aims The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Methods Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4 mmol/mol) lower HbA1c. Results Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p < 0.0001)). Conclusions Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach.

Originalsprog	Engelsk
Tidsskrift	Diabetes Research and Clinical Practice
Vol/bind	123
Sider (fra-til)	143-148
ISSN	0168-8227
DOI	https://doi.org/10.1016/j.diabres.2016.11.003
Status	Udgivet - 2017

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10.1016/j.diabres.2016.11.003

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Pedersen-Bjergaard, U., Kristensen, P. L., Beck-Nielsen, H., Nørgaard, K., Perrild, H., Christiansen, J. S., Jensen, T., Parving, H. H., Thorsteinsson, B., & Tarnow, L. (2017). The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial. Diabetes Research and Clinical Practice, 123, 143-148. https://doi.org/10.1016/j.diabres.2016.11.003

The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial. / Pedersen-Bjergaard, Ulrik; Kristensen, Peter L.; Beck-Nielsen, Henning et al.

I: Diabetes Research and Clinical Practice, Bind 123, 2017, s. 143-148.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Pedersen-Bjergaard, U, Kristensen, PL, Beck-Nielsen, H, Nørgaard, K , Perrild, H, Christiansen, JS, Jensen, T, Parving, HH, Thorsteinsson, B & Tarnow, L 2017, 'The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial', Diabetes Research and Clinical Practice, bind 123, s. 143-148. https://doi.org/10.1016/j.diabres.2016.11.003

Pedersen-Bjergaard U, Kristensen PL, Beck-Nielsen H, Nørgaard K , Perrild H, Christiansen JS et al. The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial. Diabetes Research and Clinical Practice. 2017;123:143-148. doi: 10.1016/j.diabres.2016.11.003

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title = "The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial",

abstract = "Aims The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Methods Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4 mmol/mol) lower HbA1c. Results Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p < 0.0001)). Conclusions Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach.",

keywords = "HbA1c, Human insulin, Insulin analogs, Personalized therapy, Severe hypoglycemia, Type 1 diabetes",

author = "Ulrik Pedersen-Bjergaard and Kristensen, {Peter L.} and Henning Beck-Nielsen and Kirsten N{\o}rgaard and Hans Perrild and Christiansen, {Jens S.} and Tonny Jensen and Parving, {Hans Henrik} and Birger Thorsteinsson and Lise Tarnow",

year = "2017",

doi = "10.1016/j.diabres.2016.11.003",

language = "English",

volume = "123",

pages = "143--148",

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T1 - The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial

AU - Pedersen-Bjergaard, Ulrik

AU - Kristensen, Peter L.

AU - Beck-Nielsen, Henning

AU - Nørgaard, Kirsten

AU - Perrild, Hans

AU - Christiansen, Jens S.

AU - Jensen, Tonny

AU - Parving, Hans Henrik

AU - Thorsteinsson, Birger

AU - Tarnow, Lise

PY - 2017

Y1 - 2017

N2 - Aims The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Methods Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4 mmol/mol) lower HbA1c. Results Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p < 0.0001)). Conclusions Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach.

AB - Aims The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Methods Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4 mmol/mol) lower HbA1c. Results Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p < 0.0001)). Conclusions Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach.

KW - HbA1c

KW - Human insulin

KW - Insulin analogs

KW - Personalized therapy

KW - Severe hypoglycemia

KW - Type 1 diabetes

U2 - 10.1016/j.diabres.2016.11.003

DO - 10.1016/j.diabres.2016.11.003

M3 - Journal article

C2 - 28012403

AN - SCOPUS:85006986981

SN - 0168-8227

VL - 123

SP - 143

EP - 148

JO - Diabetes Research and Clinical Practice

JF - Diabetes Research and Clinical Practice

ER -

The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial

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