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Abstract
Objectives:
The objectives were to estimate the prevalence of self-treated hypoglycaemia in patients using basal insulin analogues; identify demographic, treatment related and behavioural risk factors; and describe patient and physician responses to these events.
Research design and methods:
The GAPP2 (Global Attitude of Patients and Physicians 2) study was an online multinational cross-sectional study of patients with type 2 diabetes currently treated with basal insulin, and healthcare professionals involved in the care of such patients. The primary variable of interest was self-treated hypoglycaemia within the last 30 days.
Results:
A total of 3042 patients treated with basal insulin analogues and 1222 prescribers completed the full survey. Overall, 36% of patients had experienced self-treated hypoglycaemia during the previous 30 days. In response to self-treated hypoglycaemia, patients reported missing (7%), reducing (11%) or mistiming (4%) basal insulin doses, increasing the level of glucose monitoring (40%) or utilising healthcare resources (7%). Patients reporting irregular basal insulin dosing by missing, mistiming or reducing a dose were also significantly more likely to report an episode of self-treated hypoglycaemia in the same time period: 41% versus 34% (p = 0.004), 43% versus 33% (p < 0.001), and 56% versus 32% (p < 0.001) respectively. Nocturnal events worried significantly more patients than diurnal events (42% versus 23%, p < 0.001). Patient worry about hypoglycaemia, insulin regimen and reduced basal dosing were identified as the key differentiating variables associated with increased risk of self-treated hypoglycaemic events. Most prescribers (76%) believed that insulin analogues minimised the risk of nocturnal hypoglycaemia when compared to NPH insulin; 46% also reported being contacted at least once a month by insulin analogue patients after self-treated hypoglycaemic events.
Conclusions:
Self-treated hypoglycaemia is common in approximately one third of patients using insulin analogue regimens. Additionally, self-treated hypoglycaemia was found to be associated with clinically significant effects on patient well-being and functioning, patient and physician management and healthcare utilisation despite the potential limitations of an online self-complete survey such as the need to be topic focused, the potential for under-reporting and social bias.
Transparency
Declaration of funding
The GAPP2 study was funded by Novo Nordisk A/S. The role of the sponsor was to appoint an independent medical communications company (FTI Consulting) and research company (Bryter Research). All authors have been involved in the design, conduct, and interpretation of the study. M.B. was involved in preparing the manuscript. A.H.B. and A.R. have reviewed the manuscript for scientific content.
Declaration of financial/other relationships
M.B. and A.H.B. have received consulting fees and support for travel to meetings from Novo Nordisk in association with the GAPP2 study. A.R. is an employee of Novo Nordisk A/S.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgements
The authors would like to thank Professor Mark Peyrot of Loyola University Maryland and Helen Clark MChem MPH of FTI Consulting who supported the design, conduct and analysis of the study. In addition, they would like to acknowledge both Helen Clark MChem MPH (FTI Consulting) and Dr Christopher Burton (Point Of Care Medical Consulting) for providing medical writing assistance and Gary Bennett (Logit Research) for performing the CHAID statistical analysis (all supported by Novo Nordisk A/S).