Use of continuous glucose monitoring trend arrows in the younger population with type 1 diabetes

Early control of glycaemia is key to reduce vascular complications in individuals with Type 1 diabetes. Therefore, encouraging children and adolescents with T1DM to take responsibility for controlling glucose levels is an important yet a challenging task. The rapid expansion of continuous glucose monitoring (CGM) systems has allowed for more comprehensive analysis of glycaemia in T1D. Moreover, CGM devices have the ability to calculate rate of change in glucose levels and display the information as trend arrows. In turn, this can help to take evasive actions to return glucose levels to near physiological glycaemia, which can be highly motivating for young people with T1DM. In the absence of standardised, evidence-based guidance, this consensus document, generated by experts from the Arab Society of Paediatric Endocrinology and Diabetes and international advisors, summarises recent literature on the use of trend arrows in young people with T1DM. The use of trend arrows in different CGM systems is reviewed and their clinical significance is highlighted. Adjusting insulin doses according to trend arrows is discussed while also addressing special situations, such as exercise, fasting, nocturnal hypoglycaemia and menstruation. Adequate understanding of trend arrows should facilitate optimisation of glycaemic control in the T1D population.

Nocturnal Hypoglycaemia in Patients with Diabetes Mellitus: Database Analysis of a Cohort Using Telemedicine Support for Self-Monitoring of Blood Glucose over a 10-Year-Long Period

Background and Objectives: In patients with diabetes mellitus, hypoglycaemic episodes, especially during night hours, carry a significant risk. Data about the occurrence of nocturnal hypoglycaemia in real-world settings are of clinical importance. The aim of our study was to evaluate the occurrence of nocturnal hypoglycaemia among patients with diabetes using self-monitoring of blood glucose (SMBG) with telemedicine support. Materials and Methods: We retrospectively analysed the central database of an internet-based supportive system between 2010 and 2020 when 8190 SMBG users uploaded nearly 10 million capillary blood glucose values. Nocturnal hypoglycaemia was defined as capillary blood glucose < 3.0 mmol/L measured between 00:00 and 05:59 h. Results: The database contained 914,146 nocturnal blood glucose values from 7298 users; 24,623 (2.7%) glucose values were below the hypoglycaemic threshold and 2363 patients (32.4%) had at least one hypoglycaemic glucose value. Nocturnal hypoglycaemia was more often found in patients with type 1 vs. type 2 diabetes (n = 1890 (80.0%) vs. n = 387 (16.4%), respectively). Hypoglycaemic blood glucose values were most frequently observed in the age group of 10.0–19.9 years (n = 481 (20.4%)). Patients with nocturnal hypoglycaemia were mostly on insulin treatment (1854 (78.5%) patients with 20,727 (84.1%) hypoglycaemic glucose values). Only 356 patients (15.1%) with nocturnal hypoglycaemia performed a retest within 120 min. Within a one-day-long (1440 min) timeframe, the elapsed median time until a retest, yielding a safe blood glucose value (>3.9 mml/L), was 273 min (interquartile range: 157–300 min). Conclusions: Nocturnal hypoglycaemia should be considered as a persisting challenge to antihyperglycaemic treatment in patients living with diabetes. Continuous efforts are needed to improve both antihyperglycaemic treatment and patient education for preventing nocturnal hypoglycaemia, and to act adequately if hypoglycaemic values are detected.

Rationale and methodology for a European pooled analysis of postmarketing interventional and observational studies of insulin glargine 300 U/mL in diabetes: protocol of REALI project

IntroductionType 2 diabetes mellitus (T2DM) is a common and heterogeneous disease. Using advanced analytic approaches to explore real-world data may identify different disease characteristics, responses to treatment and progression patterns. Insulin glargine 300 units/mL (Gla-300) is a second-generation basal insulin analogue with preserved glucose-lowering efficacy but reduced risk of hypoglycaemia. The purpose of the REALI pooled analysis described in this paper is to advance the understanding of the effectiveness and real-world safety of Gla-300 based on a large European patient database of postmarketing interventional and observational studies.Methods and analysisIn the current round of pooling, REALI will include data from up to 10 000 subjects with diabetes mellitus (mostly T2DM) from 20 European countries. Outcomes of interest include change from baseline to week 24 in haemoglobin A1c, fasting plasma glucose, self-measured plasma glucose, body weight, insulin dose, incidence and rate of any-time-of-the-day and nocturnal hypoglycaemia. The data pool is being investigated using two complementary methodologies: a conventional descriptive, univariate and multivariable prognostic analysis; and a data-mining approach using subgroup discovery to identify phenotypic clusters of patients who are highly associated with the outcome of interest. By mid-2019, deidentified data of 7584 patients were included in the REALI database, with a further expected increase in patient number in 2020 as a result of pooling additional studies.Ethics and disseminationThe proposed study does not involve collection of primary data. Moreover, all individual study protocols were approved by independent local ethics committees, and all study participants provided written informed consent. Furthermore, patient data is deidentified before inclusion in the REALI database. Hence, there is no requirement for ethical approval. Results will be disseminated via peer-reviewed publications and presentations at international congresses as data are analysed.

A systematic review of the effect of prior hypoglycaemia on cognitive function in type 1 diabetes

Background: The effect of prior hypoglycaemia on cognitive function in type 1 diabetes is an important unresolved clinical question. In this systematic review, we aimed to summarize the studies exploring the impact of prior hypoglycaemia on any aspect of cognitive function in type 1 diabetes. Methods: We used a multidatabase search platform Healthcare Database Advanced Search to search Medline, PubMed, EMBASE, EMCARE, CINAHL, PsycINFO, BNI, HMIC, and AMED from inception until 1 May 2019. We included studies on type 1 diabetes of any age. The outcome measure was any aspect of cognitive function. Results: The 62 studies identified were grouped as severe hypoglycaemia (SH) in childhood (⩽18 years) and adult-onset (>18 years) diabetes, nonsevere hypoglycaemia (NSH) and nocturnal hypoglycaemia (NH). SH in early childhood-onset diabetes, especially seizures and coma, was associated with poorer memory (verbal and visuospatial), as well as verbal intelligence. Among adult-onset diabetes, SH was associated with poorer cognitive performance in the older age (>55 years) group only. Early versus late exposure to SH had a significant association with cognitive dysfunction (CD). NSH and NH did not have any significant association with CD, while impaired awareness of hypoglycaemia was associated with poorer memory and cognitive-processing speeds. Conclusion: The effect of SH on cognitive function is age dependent. Exposure to SH in early childhood (<10 years) and older age groups (>55 years) was associated with a moderate effect on the decrease in cognitive function in type 1 diabetes [PROSPERO ID: CRD42019141321].

VP53 Long-Acting Insulin Analogues In Brazil: Clinical And Economic Impact

IntroductionThe aim was to evaluate the effectiveness, safety and economic impact of long-acting insulin analogues (LAIA) compared to NPH for type 1 diabetes mellitus (DM1).MethodsA search was performed in five electronic databases to find systematic reviews (SR) comparing at least a LAIA to NPH insulin for DM1. Budget impact analysis was performed from the perspective of Brazilian public health system (SUS), with NPH insulin as the base scenario. The costs were extracted from the Integrated System of Administration of General Services (SIASG). The market share was calculated per month, using a logarithmic function with maximum diffusion of 50% at the end of the time horizon - five years.ResultsA total of 160 studies were identified and seven SR of low to uncertain risk of bias were selected. LAIA have shown modest clinical benefit and its effect is more prominent for the control of severe and nocturnal hypoglycaemia. Insulins glargine and detemir compared to NPH were associated with reduction in HbA1c levels between 0.16% and 0.40% and associated with lower risk of episodes of severe hypoglycemia. Insulin degludec compared to NPH showed no statistically significant difference in the reduction of HbA1c levels and in the episodes of severe hypoglycemia. The budget impact ranges from USD 210 million (detemir) to USD 670 million (degludec) over five years.ConclusionsThe use of LAIA as a basal insulin regimen for DM1 may benefit more patients with recurrent episodes of hypoglycemia. However, the fragility of the outcomes considered to evaluate the clinical impact of LAIA and the high budget impact with its use should be considered, and may compromise SUS sustainability. In view of these aspects, CONITEC recommended the incorporation of one of the LAIA, if the treatment is equal to or less than that of NPH insulin and according to the criteria established by a guideline.