Fear of High Blood Sugar in Pregnancy Questionnaire: development of a person-reported outcome measure to assess fear of hyperglycaemia in pregnant women with type 1 diabetes

BackgroundAlthough newer diabetes technologies improve glycaemic outcomes in type 1 diabetes pregnancies, most studies have not demonstrated improvements in scores on person-reported outcome measures (PROMs). This is likely because commonly used PROMs do not effectively capture quality-of-life concerns of greatest importance to pregnant women with type 1 diabetes. AimsWe aimed to develop a research questionnaire to evaluate fear of hyperglycaemia in type 1 diabetes pregnancies, which is an important person-reported outcome in this population. MethodsThe format of the questionnaire was modelled after that of the Hypoglycaemia Fear Survey-II. Items pertaining to fear of hyperglycaemia, specifically in pregnancy, were developed. The questionnaire was refined using cognitive interviewing among Canadian women with experience of type 1 diabetes in pregnancy. We recruited participants sequentially and modified our questionnaire iteratively based on participants feedback. Saturation was reached when no significant changes were made by three consecutive participants. ResultsThe questionnaire was reviewed by nine participants with median type 1 diabetes duration of 22 years. The questionnaire asks about 16 behaviours to avoid hyperglycaemia in pregnancy and 12 worries related to hyperglycaemia in pregnancy. 5-point Likert scales are used to quantify frequency of behaviours and worries. ConclusionsType 1 diabetes management is challenging in pregnancy. One source of stress for women is the fear of hyperglycaemia and its effects on their unborn children. The Fear of High Blood Sugar in Pregnancy Questionnaire is a pregnancy-specific person-reported outcome measure which can begin to quantify the impact of diabetes management strategies on hyperglycaemia fear.