Supplementary appendix for "Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety and Treatment/Disease Burden Results from REAL 3"

Supplementary appendix for "Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety and Treatment/Disease Burden Results from REAL 3"</p

Plain language summary for "Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety and Treatment/Disease Burden Results from REAL 3"

Plain language summary for "Childhood growth hormone deficiency, growth hormone treatment, daily growth hormone, somapacitan, long-acting growth hormone"</p

Additional file 3: Table S1. of Multifocal gastric adenocarcinoma in a patient with LRBA deficiency

Autoantibodies evaluated in the patient. (DOCX 12 kb

Additional file 2: Figure S2. of Multifocal gastric adenocarcinoma in a patient with LRBA deficiency

The identified regions of homozygous stretches in chromosome 2, 5 and 6. Description: Blue regions indicate homozygous variants and yellow regions indicate heterozygous variants. Orange regions in parental chromosomes (F, M) indicate heterozygous variants corresponding with homozygous variants of sibling’s genotype (P). (TIFF 898 kb

Additional file 4: Table S2. of Multifocal gastric adenocarcinoma in a patient with LRBA deficiency

Selected immune system determinants longitudinally evaluated in the patient. (DOCX 15 kb

Additional file 1: Figure S1. of Multifocal gastric adenocarcinoma in a patient with LRBA deficiency

Workflow of WES filtering process with multiple filtering steps including a phenotype driven filtering. (PDF 308 kb

Additional file 5: Figure S3. of Multifocal gastric adenocarcinoma in a patient with LRBA deficiency

Ultrasound and histopathologic images of the gastric cancer. Description: (a.) Ultrasound image of a 49 × 44 mm large tumor formation in the stomach; (b., c.) histopathologic images of bioptic material from the gastric tumor demonstrating intestinal type gastric carcinoma with lamina propria invasion (Kreyberg trichrom stain, 20X magnification (b.) 100X magnification (c.)). The square in part b. indicates the area of magnification in part c. of the figure. (PDF 223 kb

Continuous glucose monitoring for the routine care of type 2 diabetes mellitus

Although continuous glucose monitoring (CGM) devices are now considered the standard of care for people with type 1 diabetes mellitus, the uptake among people with type 2 diabetes mellitus (T2DM) has been slower and is focused on those receiving intensive insulin therapy. However, increasing evidence now supports the inclusion of CGM in the routine care of people with T2DM who are on basal insulin-only regimens or are managed with other medications. Expanding CGM to these groups could minimize hypoglycaemia while allowing efficient adaptation and escalation of therapies. Increasing evidence from randomized controlled trials and observational studies indicates that CGM is of clinical value in people with T2DM on non-intensive treatment regimens. If further studies confirm this finding, CGM could soon become a part of routine care for T2DM. In this Perspective we explore the potential benefits of widening the application of CGM in T2DM, along with the challenges that must be overcome for the evidence-based benefits of this technology to be delivered for all people with T2DM

InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design

Introduction: Suboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro- and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need. Methods: InRange is a multicentre, randomised, active-controlled, parallel-group, 12-week, open-label, phase 4, comparative study. Adults with T1D will be randomised to receive once-daily Gla-300 or IDeg-100 by subcutaneous injection in the morning. Following an 8-week titration period, CGM data will be collected over 20 consecutive days. Planned outcomes: The primary objective is to demonstrate that Gla-300 is noninferior to IDeg-100 in terms of glycaemic control [time-in-range ≥ 70 to ≤ 180 mg/dL (≥ 3.9 to ≤ 10 mmol/L)] and variability, as assessed using CGM, in adults with T1D. The results are expected to help confirm the utility of CGM in clinical practice in this population and provide insight into its application as an outcome measure in clinical practice. Trial registration: NCT04075513

Intermittent Use of Continuous Glucose Monitoring: A New Paradigm in Treatment of Type 2 Diabetes

Objectives: To suggest how continuous glucose monitoring (CGM) may be used intermittently in individuals with type 2 diabetes (T2D). Materials and methods: The use of CGM is largely in those with type 1 diabetes (T1D), in whom it makes sense to use CGM continuously as CGM provides a valuable tool to not only adjust their insulin doses but also to match it with their diet, physical activity, and other lifestyle modifications. In the case of T2D, however, especially for those not on insulin, the use of CGM may not be needed on a continuous basis. The use of CGM on an intermittent basis is rarely discussed in the literature. This article tries to provide clinical situations where CGM can be used intermittently. Results: Intermittent use of CGM defined as the “use of CGM once in 2 or 3 months or a fixed frequency,” and may be useful in several situations in those with T2D. We suggest the following indications for the intermittent use of CGM in T2D—newly diagnosed patients where treatment is being started, uncontrolled diabetes where treatment is being altered, starting intensive lifestyle modification, during infections, during preoperative control, in children and adolescents with T2D, as a motivational tool to improve behavioral modification, after metabolic surgery, and in patients on steroids, apart from other indications. Conclusion: Intermittent use of CGM in T2D can be useful in special situations and can also be cost saving particularly in resource-constrained regions of the world.</p