TY - CHAP
T1 - Assessing fear of hypoglycaemia in newly diagnosed patients with Type 1 diabetes
AU - Alhadj Ali, Mohammad
AU - Liu, Yuk-Fun
AU - Howell, Alex
AU - Eckhardt, Laura
AU - Kyne, Deirdre
AU - Green, Kate
AU - Walkey, Helen
AU - Peakman, Mark
AU - Dayan, Colin
AU - The MonoPepT1De Research Group
PY - 2016/3
Y1 - 2016/3
N2 - In type 1 diabetes, hypoglycaemia is the most common side effect of insulin therapy and a major barrier to achieving optimal glycaemic control. Hypoglycaemia is defined by low levels of blood glucose that can trigger multiple negative physiological outcomes. Here, we describe fear of hypoglycaemia (FoH) assessment in new-onset type 1 diabetes by using the Hypoglycaemia Fear Survey (HFS-II) in a Phase 1b trial of peptide immunotherapy.
Methods:
The MonoPepT1De trial was a multi-centre, randomised; double-blind study of intradermal PI C19-A3 peptide administered at high frequency (every 14 days), low frequency (every 28 days) or placebo alone. 27 patients aged 18-45 with HLA-DRB1*0401 genotype, autoantibody positivity and a stimulated c-peptide level >0.2pmol/ml were recruited within 100 days of diagnosis. Assessment with HFS-II was performed at baseline, 3, 6 and 12 months.
Results:
A trend was seen in the 3 trial groups towards a reduction in HFS-II score at 12 months with a significant difference from baseline in placebo group (P=0.0001), high frequency group (P=0.03) and combined treatment (P=0.01). The worry subscale score was significantly reduced in the placebo and combined treatment groups (P=0.0007 and P=0.04 respectively).
Conclusion:
Fear of hypoglycaemia is reduced in the first year of type 1 diabetes. HFS-II can provide a practical tool for assessing the impact of newly developed therapies on hypoglycaemia and identifying patients who may require additional support in dealing with hypoglycaemia.
More trials are needed to increase our understanding of the natural history of FoH in type 1 diabetes, particularly early in disease onset, and its impact on glycaemic control.
AB - In type 1 diabetes, hypoglycaemia is the most common side effect of insulin therapy and a major barrier to achieving optimal glycaemic control. Hypoglycaemia is defined by low levels of blood glucose that can trigger multiple negative physiological outcomes. Here, we describe fear of hypoglycaemia (FoH) assessment in new-onset type 1 diabetes by using the Hypoglycaemia Fear Survey (HFS-II) in a Phase 1b trial of peptide immunotherapy.
Methods:
The MonoPepT1De trial was a multi-centre, randomised; double-blind study of intradermal PI C19-A3 peptide administered at high frequency (every 14 days), low frequency (every 28 days) or placebo alone. 27 patients aged 18-45 with HLA-DRB1*0401 genotype, autoantibody positivity and a stimulated c-peptide level >0.2pmol/ml were recruited within 100 days of diagnosis. Assessment with HFS-II was performed at baseline, 3, 6 and 12 months.
Results:
A trend was seen in the 3 trial groups towards a reduction in HFS-II score at 12 months with a significant difference from baseline in placebo group (P=0.0001), high frequency group (P=0.03) and combined treatment (P=0.01). The worry subscale score was significantly reduced in the placebo and combined treatment groups (P=0.0007 and P=0.04 respectively).
Conclusion:
Fear of hypoglycaemia is reduced in the first year of type 1 diabetes. HFS-II can provide a practical tool for assessing the impact of newly developed therapies on hypoglycaemia and identifying patients who may require additional support in dealing with hypoglycaemia.
More trials are needed to increase our understanding of the natural history of FoH in type 1 diabetes, particularly early in disease onset, and its impact on glycaemic control.
M3 - Meeting abstract
VL - 33
BT - Diabetic Medicine
PB - Wiley
ER -
