Continuous Glucose Monitoring Research Articles

Improvement in Newly Defined Continuous Glucose Monitor Metrics, Extended Hypoglycemia, and Extended Hyperglycemia With Automated Insulin Delivery Initiation in Adults With Type 1 Diabetes.

Extended hypoglycemia (Ehypo) and extended hyperglycemia (Ehyper) are recently defined continuous glucose monitoring (CGM) metrics by the International Consensus for clinical trials as secondary endpoints for continuous outcomes. This study aims to evaluate the changes in Ehypo and Ehyper before and after automated insulin delivery (AID) initiation in adults with type 1 diabetes (T1D). This is a retrospective single-center study that evaluated Ehypo and Ehyper in addition to other CGM metrics in 154 adults that initiated an AID system. Metrics were compared before and after AID initiation by Wilcoxon signed-rank test. Median (interquartile range) Ehypo (<70 mg/dL) events/week decreased from 0.1 (0-0.4) to 0 (0-0.1) and Ehyper (>250 mg/dL) events/week decreased from 2.2 (0.9-4.5) to 0.8 (0.3-1.7) (both P < .001) after AID initiation compared with before AID initiation. All other CGM metrics improved after AID initiation. There was a strong positive correlation between Ehyper (>250 mg/dL) and mean glucose (before AID: r = 0.947, after AID: r = 0.894), glucose management indicator (before AID: r = 0.947, after AID: r = 0.887), and time above range (TAR; >180 mg/dL) (before AID: r = 0.957, after AID: r = 0.917) and a strong positive correlation between Ehypo (<70 mg/dL) and time below range (TBR; <70 mg/dL) (before AID: r = 0.823, after AID: r = 0.608) before and after AID initiation, respectively. Automated insulin delivery initiation significantly improved Ehypo and Ehyper metrics. Ehypo and Ehyper had a strong positive correlation with TBR and TAR, respectively. Ehypo and Ehyper events can be used in addition to TBR and TAR metrics in clinical studies as secondary outcomes.

The clinical importance of measuring glycaemic variability: Utilising new metrics to optimise glycaemic control.

With the widespread use of continuous glucose monitoring (CGM), glycaemic variability (GV) is a glucose metric that has been gaining increasing attention. However, unlike other glucose metrics that are easily defined and have clear targets, GV has a large number of different measures given the complexity involved in assessment. While variabilities in HbA1c, fasting and postprandial glucose have been incorporated under the GV banner, short-term variability in glucose, within day and between days, is more in keeping with the correct definition of GV. This review is focused on short-term GV, as assessed by CGM data, although studies calculating GV from capillary glucose testing are also mentioned as appropriate. The different measures of GV are addressed, and their potential role in microvascular and macrovascular complications, as well as patient-related outcomes, discussed. It should be noted that the independent role of GV in vascular pathology is not always clear, given the inconsistent findings in different populations and the close association between GV and hypoglycaemia, itself an established risk factor for adverse outcomes. Therefore, this review attempts, where possible, to disentangle the contribution of GV to diabetes complications from other glycaemic parameters, particularly hypoglycaemia. Evidence to date strongly suggests an independent role for GV in vascular pathology but future large-scale outcome studies are required to fully understand the exact contribution of this metric to vascular complications. This can be followed by setting appropriate GV measures and targets in different diabetes subgroups, in order to optimise glycaemic management and limit the risk of complications.

Caregiver satisfaction with the use of continuous glucose monitoring and flash glucose monitoring in very young children with type 1 diabetes

BackgroundNew technologies for the management of children with type 1 diabete (T1D) are constantly and rapidly evolving. However, few real-life studies have been conducted, and rarely in the youngest patients (<6 years). AimTo study parental satisfaction with continuous and flash glucose monitoring devices in young children with T1D. MethodsA questionnaire was completed by the parents of 114 children under the age of 6 years with T1D treated with an insulin pump followed-up in one of the hospitals of the French ADIM network between January and July 2020. ResultsOne hundred and nine patients (96 %) were equipped with a glucose monitor and 95 % (104/109) of parents stated that they were satisfied or very satisfied with their child's monitoring device, with no significant difference in satisfaction rates between flash and continuous glucose monitoring. The parameter most strongly associated with satisfaction was confidence in the reliability of the device (p = 0.008). Parents who struggled to apply the device were significantly less satisfied (p = 0.024). In real-life use, 83 % of parents (90/109) used additional adhesives, 28 % reported mild skin reactions (30/108) and 39 % severe skin reactions (42/108), 50 % stated that applying the device was not painful, and 95 % found the device easy to apply. The most commonly reported unexpected difficulties were device malfunction (by 16 respondents), the device being too large and causing scarring (6 respondents), and lengthy calibration (6 respondents). ConclusionThe vast majority of parents in this group of young children with T1D were satisfied with continuous or flash glucose monitoring. Satisfaction was strongly associated with confidence in the reliability of the device. Reported adverse effects such as skin reaction and difficulties attaching the device highlight the importance of data on real-life use.

β-Cell Secretory Capacity Predicts Metabolic Outcomes over 6 Years following Human Islet Transplantation.

Transplanted islet functional β-cell mass is measured by the β-cell secretory capacity derived from the acute insulin response to glucose-potentiated arginine (AIRpot), however, data are limited beyond one-year post-transplant for individuals with type 1 diabetes. We evaluated changes in β-cell secretory capacity in a single-center longitudinal analysis and examined relationships with measures of islet cell hormone metabolism and clinical measures of graft function (mixed-meal tolerance test [MMTT] C-peptide, BETA-2 score, and continuous glucose monitoring [CGM]). Eleven individuals received purified human pancreatic islets over one or two intra-portal infusions to achieve insulin-independence and were followed over a median (IQR) 6 (5-7) years. β-cell secretory capacity remained stable over 3-years before declining. Fasting glucagon and proinsulin secretory ratios under glucose-potentiation were inversely correlated with AIRpot. A functional β-cell mass of 40% normal predicted insulin-independence and was strongly predicted by MMTT C-peptide-to-glucose and BETA-2 score. A functional β-cell mass of >20% predicted excellent glycemic outcomes including ≤1% time <60 mg/dL, ≤2% time >180 mg/dL and ≥90% time-inrange 70-180 mg/dL. β-cell replacement approaches should target a functional β-cell mass >40% to provide sufficient islet reserve for sustained insulin-independence. MMTT C-peptide-to-glucose and BETA-2 score can inform changes in functional β-cell mass in the clinical setting.

Telemedicine for Managing Type 1 Diabetes in Children and Adolescents Before and After the COVID-19 Pandemic

The COVID-19 pandemic has catalyzed the rapid expansion of telemedicine for managing chronic conditions such as type 1 diabetes (T1D) in children and adolescents. This narrative review aims to explore the role of telemedicine in pediatric T1D management by comparing its use before and after the pandemic. We conducted a comprehensive literature review covering studies published between 2000 and 2024, focusing on telemedicine applications in pediatric T1D care. The review includes clinical trials, systematic reviews, and observational studies examining telemedicine’s impact on glycemic control, patient satisfaction, and healthcare delivery. Results reveal that telemedicine has enhanced access to care, improved glycated hemoglobin (HbA1c) levels, and reduced diabetic ketoacidosis and hypoglycemic events. Patients and caregivers expressed high satisfaction, especially when using continuous glucose monitoring and insulin pump technologies integrated with telemedicine platforms. However, challenges such as digital literacy gaps, variability in healthcare provider training, and logistical issues like reimbursement policies persist. The pandemic highlighted the potential of telemedicine to supplement traditional in-person care, showing promise in enhancing patient outcomes and reducing healthcare burdens. Further research is needed to optimize telemedicine models for T1D, addressing barriers to implementation and exploring its long-term cost-effectiveness. This review underscores telemedicine’s evolving role as a complementary approach in managing pediatric T1D, advocating for the development of standardized care protocols to fully integrate digital health solutions into routine clinical practice.

Continuous Glucose Monitor Accuracy for Diabetes Management in Hospitalized Children

OBJECTIVE The adoption of continuous glucose monitors (CGMs) in inpatient settings in the pediatric population has been slow because of a scarcity of data on their reliability in hospitalized children. RESEARCH DESIGN AND METHODS We retrospectively reviewed the accuracy of the Dexcom G6 CGM system in pediatric patients with diabetes admitted to our academic children’s hospital from March 2018 to September 2023. We cross-referenced the Dexcom Clarity database against an internal database of inpatient admissions to identify all children with CGM data admitted to the hospital. We recorded sensor glucose readings from Clarity and values for point-of-care (POC) glucose, blood urea nitrogen (BUN), and pH from the electronic medical record. CGM accuracy and clinical reliability were measured by mean absolute relative difference (MARD) and Clarke error grid (CEG) analyses. RESULTS There were 3,200 admissions of children with diabetes in this period, of which 277 (from 202 patients age 2–18 years) had associated CGM data. Paired CGM and POC measurements (n = 2,904) were compared, resulting in an MARD of 15.9%, with 96.6% of the values in zones A and B of the CEG analysis. Approximately 62% of paired values fell within a 15% or 15 mg/dL difference, whichever was larger (15%/15 mg/dL range), 74% within 20%/20, and 88% within 30%/30. Serum pH, sodium, and BUN had no impact on CGM values or absolute relative difference in linear regression analysis. CONCLUSIONS CGMs demonstrated acceptable accuracy in hospitalized children with diabetes. CGM data should be integrated into hospital electronic records to optimize management.

Changes in glucose variability and diabetes control in children and young adults with type 1 diabetes on routine continuous glucose monitoring and continuous subcutaneous insulin therapy following a switch to hybrid closed-loop therapy (MiniMed 780G) – retrospective study

IntroductionAdvanced hybrid closed loop (AHCL) insulin delivery systems offer considerable benefits to individuals with type 1 diabetes (T1D) in terms of glucose control and quality of life. With increasing numbers of regular users, real-life long-term data on long-term AHCL effectiveness become available.Material and methodsThis was a single-centre retrospective study. We included children and young adults (age 5–25 years ) with established T1D (≥ 3 m) who started MiniMed780G therapy between January 2021 and April 2022. We excluded those naïve to continuous glucose monitoring (CGM) or insulin pumps, as well as those without good-quality baseline CGM data. Included patients were followed for 12 months, with CGM and pump data retrieved from 14-day periods before transition and 3, 6, 9, and 12 months following the start of automode. Clinical data (body weight, height, glycated haemoglobin concentration) were recorded from the most recent outpatient visits.ResultsAmong 81 patients who started AHCL therapy, 46 met the criteria for analysis (mean age 11.5 ±4.4 years, diabetes duration 4.4 ±3.6 years, mean glycated haemoglobin 7.0 ±1.0%). Over the year following transition, we noted a significant improvement in time in target range 70–180 mg/dl (TIR, baseline: 69.1 ±12.0% to 12 m: 76.9 ±8.5%, &lt;i&gt;p&lt;/i&gt; &lt; 0.0001) and time in tight range 70–140 mg/dl (baseline: 45.3 ±14.2% to 12 m: 53.3 ±10.4%, &lt;i&gt;p&lt;/i&gt; &lt; 0.0001). Time below target range 70 mg/dl (TBR70 mg/dl) decreased significantly for 24-hour records (&lt;i&gt;p&lt;/i&gt; = 0.0020). Importantly, those improvements were not accompanied by an increase in daily dose of insulin or body mass index.ConclusionsA prolonged 12-month-long observation in a routine care setting demonstrates that for young CGM- and pump users with T1D, switch AHCL offers sustained benefits in glucose variability.

Automated Insulin Delivery Effects During Driving Among Older Adults with Type 1 Diabetes in a Randomized Trial.

Dysglycemia among drivers with type 1 diabetes (T1D) is associated with impaired driving performance, and glucose levels "above 5 to drive" are often recommended for insulin-treated drivers. Evidence for diabetes treatments that support euglycemia while driving is minimal, particularly for older drivers. In this randomized, crossover trial involving adults aged ≥60 years with T1D, we used continuous glucose monitoring (CGM) during driving to compare the first-generation closed-loop automated insulin delivery (AID) versus a sensor-augmented pump therapy. There were 1894 trips undertaken by 8 drivers (median age 68 years [IQR: 64-70]). During AID versus sensor-augmented pump, time in range >5.0-10.0 mmol/L was greater (100% [0-100] vs. 81% [0-100]; P = 0.033) and fewer trips had any CGM >16.7 mmol/L (3.5% vs. 6.4%; P = 0.006). Three percent of all trips included CGM <3.9 mmol/L, with no between-stage difference (3.0% vs. 3.5%; P = 0.52). System alerts occurred in 10% of all trips, with no between-stage difference (9% vs. 11%; P = 0.078). First-generation AID reduces hyperglycemic driving among older drivers with T1D, without increasing hypoglycemia. Developing dedicated "driving-mode" settings could prioritize safety while minimizing distraction. Trial Registration: ACTRN12619000515190.

Glucose control and variability assessed by continuous glucose monitoring in patients with type 1 diabetes and diabetic kidney disease

Glucose control and variability assessed by continuous glucose monitoring in patients with type 1 diabetes and diabetic kidney disease

Safety and efficacy of different basal insulin in type 2 diabetes mellitus with chronic kidney disease in Ramadan: prospective observational study

BackgroundDiabetic kidney disease populations are categorized as high risk for fasting in Ramadan due to various potential fasting-related complications. Insulin analogues are recommended to be used in place of human insulin during fasting, as they carry a lower risk of hypoglycaemia and stable glycaemic variability. A paucity of data exits on the safety and efficacy of different basal insulin types during fasting for this population. This study aims to evaluate the safety and efficacy of three basal insulin among patients with Type 2 Diabetes Mellitus and concomitant mild to moderate chronic kidney disease who are keen to fast during Ramadan.Materials and methodsA single-centered, prospective observational study was conducted among 46 patients with type 2 diabetes mellitus and concomitant chronic kidney disease stage 2 and 3 who were on three different types of basal insulin (Glargine U-100, Levemir, and Insulatard), fasted in Ramadan 2022. All variables were listed as median (IQR). Hypoglycaemia events and glycemic variability obtained from Freestyle Libre continuous glucose monitoring were compared between insulin groups. Changes in glycated haemoglobin, fasting plasma glucose, renal profile, body weight, body mass index, and waist circumference pre and post-Ramadan were evaluated. ResultsThe glycaemic variability was found highest in Insulatard with a median (IQR) of 37.2(33)% versus Levemir 34.4(32.4)% versus Glargine U-100 36.8(30.6)%, p = NS. Levemir had reported the lowest median time of below range of 2.5(13)% followed by Glargine 4(25)% and Insulatard 5(8)%; p = NS. The findings of this study indicated that glycated haemoglobin, fasting plasma glucose, renal profile, body weight, body mass index, and waist circumference did not alter statistically between the three groups post-Ramadan. Individually, Insulatard showed a significant reduction in weight and waist circumference (0.9kg, p = 0.026; 0.44 cm, p = 0.008) while Levemir showed a reduction in waist circumference (0.75cm, p = 0.019).ConclusionThis study revealed that Insulatard, Levemir, and Glargine demonstrated similar levels of safety and efficacy among those with diabetic kidney disease who observed fasting during Ramadan.

Trends in Intermittent Scanning Continuous Glucose Monitoring Usage in The Netherlands—An Opportunity for Elderly Individuals with Diabetes

Background: Intermittent scanning continuous glucose monitoring (is-CGM) technology has gained widespread adoption and is known to improve glycemic control and quality of life for persons with diabetes. The elderly may lag behind in their adoption of the technology, which could be a potential avenue for improving quality of care. In this study, we investigated the adoption of is-CGM technology in the Dutch population, including effects of age. Methods: A retrospective observational study was performed using data from the Drug Information Project, a public database hosted by the Dutch National Health Care Institute. The database contained information concerning healthcare reimbursements from 2017 until 2022 and covered approximately 95% of the total population. Data concerning is-CGM and fast-acting insulin reimbursements were extracted, identifying actual and potential is-CGM users, who were subdivided into the categories 0–24, 25–44, 45–64, 65–74 and ≥75 years old. Results: From 2017 until 2022, is-CGM usage rapidly increased: from 38 to 82.050 actual users. The age categories 0–24 and 25–55 showed the highest is-CGM usage (62% and 84% of the potential population in 2022, respectively), and 65–74 and ≥75 the least (38% and 33%, respectively). However, the elderly had higher growth rates (+75% in the category ≥75 from 2021 to 2022) compared to the youngest (+54% in the category 0–24 in the same period). Conclusions: Data from this study demonstrate that the elderly lag behind in is-CGM adoption. Given the potential advantages of is-CGM for elderly persons with diabetes, we argue that strategies should be developed to address this (paradoxical) underutilization of is-CGM.

Consensus Report on the Use of Continuous Glucose Monitoring in Chronic Kidney Disease and Diabetes.

This report represents the conclusions of 15 experts in nephrology and endocrinology, based on their knowledge of key studies and evidence in the field, on the role of continuous glucose monitors (CGMs) in patients with diabetes and chronic kidney disease (CKD), including those receiving dialysis. The experts discussed issues related to CGM accuracy, indications, education, clinical outcomes, quality of life, research gaps, and barriers to dissemination. Three main goals of management for patients with CKD and diabetes were identified: (1) greater use of CGMs for better glycemic monitoring and management, (2) further research evaluating the accuracy, feasibility, outcomes, and potential value of CGMs in patients with end-stage kidney disease (ESKD) on hemodialysis, and (3) equitable access to CGM technology for patients with CKD. The experts also developed 15 conclusions regarding the use of CGMs in this population related to CGMs' unique delivery of both real-time information that can guide monitoring and management of glycemia and continuous and predictive data in this population, which is at higher risk for hypoglycemia and hyperglycemia. The group noted three major clinical gaps: (1) CGMs are not routinely prescribed for patients with diabetes and CKD; (2) CGMs are not approved by the United States Food and Drug Administration (FDA) for patients with diabetes who are on dialysis; and (3) CGMs are not routinely available to all of those who need them because of structural barriers in the health care system. These gaps can be improved with greater stakeholder collaboration, education, and awareness brought to the use of CGM technology in CKD.

Improvement of Glycemia Risk Index and Continuous Glucose Monitoring Metrics During Ramadan Fasting in Type 1 Diabetes: A Real-World Observational Study.

Managing glycemia during Ramadan is challenging for individuals with type 1 diabetes (T1D) due to prolonged fasting and altered eating patterns. While many are exempt from fasting, some choose to fast, necessitating careful monitoring. The glycemia risk index (GRI) is valuable for assessing glycemic quality and interpreting continuous glucose monitoring (CGM) data to identify individuals needing closer clinical attention. This study investigates the effects of Ramadan fasting on glycemic control in T1D, focusing on GRI and its components for hypoglycemia (CHypo) and hyperglycemia (CHyper). An ambispective study involved 186 individuals with T1D using intermittent scanning CGM (isCGM). Data were retrospectively collected for one month before Ramadan and prospectively during and one month after Ramadan. Clinical, metabolic, and glycemic data were collected, with GRI calculated alongside its components. During Ramadan, GRI improved by 54.6% (from 56.4 to 25.6), CHypo decreased by 60% (from 6 to 2.4), and CHyper dropped by 40.5% (from 21 to 12.5). However, these benefits were temporary, as glycemic measures increased after Ramadan, reflecting a return to pre-Ramadan patterns once normal routines resumed. No participants were admitted for diabetes emergencies during Ramadan. Adolescents and patients on insulin pumps had more favorable outcomes. GRI and its components significantly correlated with other CGM metrics, with these relationships maintained during and after Ramadan. Ramadan fasting significantly improved GRI and its components in individuals with T1D. Incorporating GRI as a novel metric alongside classical CGM metrics could enhance glycemic control, highlighting the need for personalized diabetes management strategies.

Tight and stable glucose control is associated with better prognosis in patients hospitalized for Covid-19 and pneumonia.

To investigate possible associations of glucose patterns with outcomes of Corona Virus Disease 19 (COVID-19) using continuous glucose monitoring (CGM) in 43 patients hospitalized for COVID-19 mild-to-moderate pneumonia, regardless of diabetes. Prospective observational study conducted during two pandemic waves in 2020-2021. Glucose sensor metrics of 7-day recording were obtained from blinded CGM. Respiratory function was evaluated as arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) ratio (PaO2:FiO2). PaO2:FiO2 ratio was positively correlated with time in tight range (TITR) 70-140 (r = 0.49, p < 0.001) and time in range (TIR) 70-180 (r = 0.32, p < 0.05), and negatively correlated with average glucose (r =- 0.31, p < 0.05), coefficient of glucose variation (CV) (r =- 0.47, p < 0.01) and time above range (TAR) > 140 (r =- 0.49, p < 0.001). No relations were observed with HbA1c. Multivariate regression analysis showed that normal respiratory function at time of CGM removal correlated positively with TITR 70-140mg/dL (p < 0.01), negatively with CV and TAR > 140mg/dL (both p < 0.05) and not with TIR 70-180 and average glucose. Lower glucose variability and optimal glucose control, expressed as CV and TITR, are CGM metrics predictive of a better prognosis in COVID-19 patients with pneumonia.

Postprandial hypoglycaemia after gastric bypass in type 2 diabetes: pathophysiological mechanisms and clinical implications.

Postprandial hypoglycaemia (PPHG) is a frequent late complication of Roux-en-Y gastric bypass (RYGB) in people without diabetes. We aimed to examine the pathogenetic mechanisms of PPHG and its clinical consequences in people with a history of type 2 diabetes. In this case-control study, 24 participants with type 2 diabetes treated with RYGB (14 women; median [IQR] age 53.5 [13.8] years, BMI 29.3 [6.3] kg/m2, HbA1c 36.0 [6.2] mmol/mol [5.4% (0.6%)]) underwent a dual-tracer, frequently sampled, 300 min, 75 g OGTT for the diagnosis of PPHG (glucose nadir <3.0 mmol/l, or <3.3 mmol/l with symptoms). Plasma glucose, glucose tracers, insulin, C-peptide, glucagon-like peptide-1, gastric inhibitory polypeptide, glucagon, adrenaline (epinephrine), noradrenaline (norepinephrine), cortisol and NEFAs were measured. Mathematical models were implemented to estimate glucose metabolic fluxes and beta cell function. ECG recordings, cognitive testing and hypoglycaemia awareness assessments were repeated during the OGTT. Glycaemic levels and dietary habits were assessed under free-living conditions. PPHG occurred in 12 (50%) participants, mostly without symptoms, due to excessive tracer-derived glucose clearance (mean group difference ± SE in AUC0-180 min +261±72 ml min-1 kg-1 × min) driven by higher whole-body insulin sensitivity and early glucose-stimulated hyperinsulinaemia, the latter depending on lower insulin clearance and enhanced beta cell function, regardless of incretin hormones. PPHG participants also had defective counterregulatory hormone responses to hypoglycaemia, preventing a physiological increase in endogenous glucose production and the appearance of symptoms and signs of sympathetic cardiovascular activation and neuroglycopenia. PPHG was associated with more frequent and prolonged hypoglycaemia on 14 day continuous glucose monitoring and alterations in free-living dietary habits. Our results demonstrate that post-bypass PPHG occurs frequently in individuals with a history of type 2 diabetes, often without warning symptoms, and expose its complex pathogenetic mechanisms, revealing potential therapeutic targets.

Stronger association between morning serum cortisol level and diurnal time in range in type 2 diabetes?

BackgroundThe hypothalamic-pituitary-adrenal axis is thought to play a vital role in glucose homeostasis and diabetes. This study investigated the association between morning serum cortisol and time in range (TIR), including daytime TIR, in type 2 diabetes (T2DM).Methods310 patients with T2DM had serum cortisol measured at 8 a.m. All participants underwent continuous glucose monitoring (CGM) for three consecutive days, then TIR and glycemic variability (GV) parameters were evaluated. Using 100 g standard steamed bread meal test, blood glucose, C peptide and insulin at different points were collected to assess insulin sensitivity and islet function.ResultsPatients with higher serum cortisol exhibited lower TIR and TITR (P < 0.001). Spearman correlation analysis showed that the negative correlation between cortisol and daytime TIR (r=-0.231, P < 0.001) was stronger than that of overnight TIR (r=-0.134, P = 0.028). Similarly, there existed a negative correlation between cortisol and pancreatic function indicators such as HOMA-β, insulinogenic index (IGI), area under the curve of C-peptide within half an hour (AUCCp0.5 h) and three hours (AUCCp3h) (r=-0.248, -0.176, -0.140, -0.185, respectively, P < 0.05). In contrast, cortisol was positively associated with TAR (r = 0.217, P < 0.001) and GV parameters including MBG, MAGE, LAGE, HBGI, MODD, ADDR (P of MAGE and MODD > 0.05). Multiple stepwise regression revealed that cortisol was an independent contributor of TIR, TITR and diurnal TIR, with diurnal TIR of stronger relevance.ConclusionsMorning serum cortisol is negatively correlated with TIR, especially diurnal TIR and positively associated with GV parameters. Inappropriate cortisol secretion may have an adverse influence on glucose homeostasis in T2DM.

Evaluating Continuous Glucose Monitoring after Total Pancreatectomy with or without islet autotransplatation: A Scoping Systematic Review.

The review was conducted adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. 15 studies including 147 patients (adult n = 71/paediatric n = 76) reported on CGM use post-TP (n = 42) and TPIAT (n = 105). 4 were randomized controlled trials and 10 observational studies. 6 studies evaluated CGM use in the peri-operative and 6 in the immediate post-operative period (n = 8) with variable follow-up (14 hours -20 months). CGM was used as a stand-alone device (8 studies) which allowed assessment of dynamic islet function and detection of hypoglycemia (n = 1) resulting in lower glucose levels (n = 1). 6 studies evaluated insulin pump with CGM with reduction in post-operative mean glucose (n = 4), and hypoglycaemic episodes (n = 2). There were no patient reported outcome measures (PROMs) or quality of life (QoL) measures reported. CGM can be used following TP for glucose monitoring and/or linked with insulin pump device in the peri-operative period with improved glycaemic control. However, the data are limited by short follow-up and lack of PROMs and QoL measures.

The Application of Continuous Glucose Monitoring Endpoints in Clinical Research: Analysis of Trends and Review of Challenges.

Considerable efforts to standardize continuous glucose monitoring (CGM) have occurred in recent years. The aim was to perform an analysis of clinical studies in clinicaltrials.gov to evaluate trends in CGM endpoint adoption. Clinicaltrials.gov was searched for studies of drugs, devices and combination products containing CGM terms posted from 2012 to 2023. 1269 studies were returned and 954 were excluded. 315 studies were divided into two periods (P1 [2012-2017] and P2 [2018-2023]) and differences analyzed using descriptive statistics and two-tailed t tests. There was a significant 60.3% increase in total clinical studies from P1 (121) to P2 (194). Phase 2 and Phase 3 Studies both saw significant increases of 125.8 and 169.2%, respectively, in P2. Adult-only studies predominated in both periods, with a 40.4% increase in P2. Studies that included pediatric populations, although smaller in number, increased significantly. Most studies were nonindustry-funded, and studies in this category saw a significant 80.0% increase in P2. However, industry-only funded studies also increased significantly by 78.4% in P2 in the same period. Studies of type 1 diabetes (T1DM) and type 2 diabetes (T2DM) increased by 55.8% and 26.9%, respectively, but increases were not statistically significant. Studies of nondiabetes-related indications did increase significantly (233.3%). 27.6% of studies used CGM-derived metrics as primary endpoints (PE). Studies that used time in range (TIR) increased by 222.4% in P2, which was significant. Conversely studies that used mean amplitude of glycemic excursions (MAGE) decreased significantly by 71.3%. Our data provide evidence of significant increases in the application of CGM endpoints in clinical studies in the last six years, including studies with TIR as the PE. Increases have been driven largely by academia, but our data show that industry is starting to follow suit. The significant increase in studies that included pediatrics is encouraging.

Treatment regimens and glycaemic outcomes in more than 100 000 children with type 1 diabetes (2013-22): a longitudinal analysis of data from paediatric diabetes registries.

Advances in paediatric type 1 diabetes management and increased use of diabetes technology have led to improvements in glycaemia, reduced risk of severe hypoglycaemia, and improved quality of life. Since 1993, progressively lower HbA1c targets have been set. The aim of this study was to perform a longitudinal analysis of HbA1c, treatment regimens, and acute complications between 2013 and 2022 using data from eight national and one international paediatric diabetes registries. In this longitudinal analysis, we obtained data from the Australasian Diabetes Data Network, Czech National Childhood Diabetes Register, Danish Registry of Childhood and Adolescent Diabetes, Diabetes Prospective Follow-up Registry, Norwegian Childhood Diabetes Registry, England and Wales' National Paediatric Diabetes Audit, Swedish Childhood Diabetes Registry, T1D Exchange Quality Improvement Collaborative, and the SWEET initiative. All children (aged ≤18 years) with type 1 diabetes with a duration of longer than 3 months were included. Investigators compared data from 2013 to 2022; analyses performed on data were pre-defined and conducted separately by each respective registry. Data on demographics, HbA1c, treatment regimen, and event rates of diabetic ketoacidosis and severe hypoglycaemia were collected. ANOVA was performed to compare means between registries and years. Joinpoint regression analysis was used to study significant breakpoints in temporal trends. In 2022, data were available for 109 494 children from the national registries and 35 590 from SWEET. Between 2013 and 2022, the aggregated mean HbA1c decreased from 8·2% (95% CI 8·1-8·3%; 66·5 mmol/mol [65·2-67·7]) to 7·6% (7·5-7·7; 59·4mmol/mol [58·2-60·5]), and the proportion of participants who had achieved HbA1c targets of less than 7% (<53 mmol/mol) increased from 19·0% to 38·8% (p<0·0001). In 2013, the aggregate event rate of severe hypoglycaemia rate was 3·0 events per 100 person-years (95% CI 2·0-4·9) compared with 1·7 events per 100 person-years (1·0-2·7) in 2022. In 2013, the aggregate event rate of diabetic ketoacidosis was 3·1 events per 100 person-years (95% CI 2·0-4·8) compared with 2·2 events per 100 person-years (1·4-3·4) in 2022. The proportion of participants with insulin pump use increased from 42·9% (95% CI 40·4-45·5) in 2013 to 60·2% (95% CI 57·9-62·6) in 2022 (mean difference 17·3% [13·8-20·7]; p<0·0001), and the proportion of participants using continuous glucose monitoring (CGM) increased from 18·7% (95% CI 9·5-28·0) in 2016 to 81·7% (73·0-90·4) in 2022 (mean difference 63·0% [50·3-75·7]; p<0·0001). Between 2013 and 2022, glycaemic outcomes have improved, parallel to increased use of diabetes technology. Many children had HbA1c higher than the International Society for Pediatric and Adolescent Diabetes (ISPAD) 2022 target. Reassuringly, despite targeting lower HbA1c, severe hypoglycaemia event rates are decreasing. Even for children with type 1 diabetes who have access to specialised diabetes care and diabetes technology, further advances in diabetes management are required to assist with achieving ISPAD glycaemic targets. None. For the Norwegian, German, Czech, Danish and Swedish translations of the abstract see Supplementary Materials section.

Investigating the effect of verapamil on preservation of beta-cell function in adults with newly diagnosed type 1 diabetes mellitus (Ver-A-T1D): protocol for a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial

IntroductionType 1 diabetes mellitus (T1DM) is a disorder that arises following the selective autoimmune destruction of the insulin-producing beta cells. Beta-cell protective or beta-cell regenerative approaches have gained wider attention,...