Previous structured education attendance and the relationship with HbA1c and hypoglycaemia awareness in people living with type 1 diabetes mellitus using FreeStyle Libre: insights from the Association of British Clinical Diabetologists (ABCD) Nationwide Audit

Background: Dose Adjustment For Normal Eating (DAFNE) is the gold standard National Institute for Health and Care Excellence (NICE) recommended structured education programme that promotes self-management in people living with type 1 diabetes (T1D). We have recently shown that FreeStyle Libre (FSL) is associated with improved haemoglobin A1c (HbA1c) and hypoglycaemia awareness. Aims: To explore the effect of structured education including DAFNE on HbA1c and GOLD score when combined with FSL use. Methods: The ABCD national audit data on FSL users were used to conduct this prospective longitudinal study. The Stu- dent’s t test was used to compare the baseline and follow-up HbA1c and a change in the GOLD score for hypoglycaemia awareness. The baseline demographic and clinical characteristics of the study population were compared using ANOVA. Linear regression analysis identified predictors of change in HbA1c with FSL use. Results: The study consisted of 14,880 people living with insulin-dependent diabetes mellitus (IDDM), 97% of whom had T1D, of which 50% were female, with a mean±SD base- line HbA1c of 70±18 mmol/mol and baseline body mass index (BMI) of 25.3±6.2 kg/m2. Follow-up data for HbA1c were avail- able for 6,446 participants while data for GOLD score were available for 5,057 participants. The study population was divided into three groups: 6,701 people with no prior structured education (Group 1), 3,964 with other structured education (Group 2), and 4,215 had previously attended DAFNE structured education (Group 3). Groups 2 and 3 who had previously attended structured education had a lower initial HbA1c than those in Group 1 (p<0.0001). However, there was a significant but similar magnitude of the fall in HbA1c across all groups (−8.10 mmol/mol vs −6.61 mmol/mol vs −6.22 mmol/mol in Groups 1, 2 and 3, respectively), with p (ANOVA)=0.83. Similarly, the decline in GOLD score was comparable in Groups 1, 2 and 3 (−0.33 vs −0.30 vs −0.34, respectively), with p (ANOVA)=0.43. Linear regression analysis identified higher baseline HbA1c (β=0.585, p<0.0001), number of FSL scans over 14 days (β=−0.026, p=0.00135) and other structured education (β=−1.207, p=0.02483) as predictors of HbA1c reduction. Prior DAFNE training was not associated with improved HbA1c reduction in the linear regression model. Conclusions: FSL use was associated with improvements in HbA1c and GOLD score. Although DAFNE is an evidence- based intervention to improve outcomes in those with T1D, DAFNE attendance prior to commencing FSL did not influence HbA1c or GOLD score outcomes when compared with FSL use alone. Other structured education was identified as a predictor of HbA1c reduction when combined with FSL use.

Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions

IntroductionSevere hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence.Methods and analysisA randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol.Ethics and disseminationThe protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups.Trial registration numberNCY02940873; Pre-results.