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Link to original content: https://pubmed.ncbi.nlm.nih.gov/22727048/
A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design - PubMed Skip to main page content
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. 2012 Jun 22:12:10.
doi: 10.1186/1472-6823-12-10.

A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

Peter Lommer Kristensen  1 , Ulrik Pedersen-Bjergaard, Henning Beck-Nielsen, Kirsten Nørgaard, Hans Perrild, Jens Sandahl Christiansen, Tonny Jensen, Hans-Henrik Parving, Birger Thorsteinsson, Lise Tarnow
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A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

Peter Lommer Kristensen et al. BMC Endocr Disord. .

Abstract

Background: Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial.

Methods/design: The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year.

Discussion: In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.

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Graphic presentation of the HypoAna study which is a prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia.
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References

    1. Banck-Petersen P, Larsen T, Pedersen-Bjergaard U, Bie-Olsen L, Høi-Hansen T, Thorsteinsson B. Concerns about hypoglycaemia and late complications in patients with insulin-treated diabetes. Eur Diabetes Nurs. 2007;4:113–118. doi: 10.1002/edn.91. - DOI
    1. Pramming S, Thorsteinsson B, Bendtson I, Binder C. Symptomatic hypoglycaemia in 411 type 1 diabetic patients. Diabet Med. 1991;8:217–222. doi: 10.1111/j.1464-5491.1991.tb01575.x. - DOI - PubMed
    1. Jørgensen HV, Pedersen-Bjergaard U, Rasmussen AK, Borch-Johnsen K. The impact of severe hypoglycemia and impaired awareness of hypoglycemia on relatives of patients with type 1 diabetes. Diabetes Care. 2003;26:1106–1109. doi: 10.2337/diacare.26.4.1106. - DOI - PubMed
    1. Cryer PE. Hypoglycemia is the limiting factor in the management of diabetes. Diabetes Metab Res Rev. 1999;15:42–46. doi: 10.1002/(SICI)1520-7560(199901/02)15:1<42::AID-DMRR1>3.0.CO;2-B. - DOI - PubMed
    1. Auer RN. Hypoglycaemic Brain Damage. Metab Brain Dis. 2004;19:169–175. - PubMed

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