Multiple Daily Injections Research Articles

Current and Future Strategies in Insulin Development and Treatment.

Recent advances in insulin research open new avenues for treatment, both, for type 1 and type 2 diabetes. In developed countries, standardized "ultra-rapid-acting insulins" are now also used in addition to rapid-acting insulins. First- and second-generation basal analogs are available. Third-generation basal analogs, which only need to be applied once a week, are in the pipeline. Second-generation "ultra-rapid-acting insulins" insulins with faster onset and offset of action may be particularly useful for multiple daily injections and automated insulin delivery systems. An improved time-action profile of bolus insulin would be able to cover the rapid increase in glucose after meals with a rapid fall thereafter to avoid postprandial hypoglycemia. The third-generation basal insulins allowing once-weekly dosing made major steps toward becoming a clinical reality. However, issues with insulin affordability and availability remain problematic even in more affluent countries. Biosimilar insulins products can provide people with additional safe, high-quality, and potentially cost-effective options for treating diabetes. Particularly in low-middle income countries insulin therapy is facing issues not only of access but also storage, lack of diabetes education, and stigma. With the new bolus insulins, the physiological insulin secretion pattern can be mimicked better and better and hypoglycemia can be avoided. With the ever longer pharmacokinetic action profiles of the basal analogs, the injection frequency is reduced, which leads to better adherence and quality of life, but these insulins are not available for everyone who needs it worldwide.

Nocturnal Glucose Profile According to Timing of Dinner Rapid Insulin and Basal and Rapid Insulin Type: An Insulclock® Connected Insulin Cap-Based Real-World Study.

A study to assess the glucose levels of people with type 1 diabetes (T1D) overnight, based on the insulin type and timing. A real-world, retrospective study of T1D, using multiple daily insulin injections. Continuous glucose monitoring and insulin injection data were collected for ten hours after dinner using the Insulclock® connected cap. Meal events were identified using the ROC detection methodology. The timing of the rapid insulin, second injections, and the type of insulin analogs used, were evaluated. The nocturnal profiles (n = 775, 49 subjects) were analyzed. A higher glucose AUC of over 180 mg/dL was observed in subjects with delayed injections (number; %; mg/dL × h): -45-15 min (n = 136; 17.5%, 175.9 ± 271.0); -15-0 min (n = 231; 29.8%, 164.0 ± 2 37.1); 0 + 45 min (n = 408; 52.6%, 203.6 ± 260.9), (p = 0.049). The use of ultrarapid insulin (FiAsp®) (URI) vs. rapid insulin (RI) analogs was associated with less hypoglycemia events (7.1 vs. 13.6%; p = 0.005) and TBR70 (1.7 ± 6.9 vs. 4.6 ± 13.9%; p = 0.003). Users of glargine U300 vs. degludec had a higher TIR (70.7 vs. 58.5%) (adjusted R-squared: 0.22, p < 0.001). The use of a correction injection (n = 144, 18.6%) was associated with a higher number of hypoglycemia events (18.1 vs. 9.5%; p = 0.003), TBR70 (5.5 ± 14.2 vs. 3.0 ± 11.1%; p = 0.003), a glucose AUC of over 180 mg/dL (226.1 ± 257.8 vs. 178.0 ± 255.3 mg/dL × h; p = 0.001), and a lower TIR (56.0 ± 27.4 vs. 62.7 ± 29.6 mg/dL × h; p = 0.004). The dinner rapid insulin timing, insulin type, and the use of correction injections affect the nocturnal glucose profile in T1D.

Advances in Nanomedicine for Precision Insulin Delivery.

Diabetes mellitus, which comprises a group of metabolic disorders affecting carbohydrate metabolism, is characterized by improper glucose utilization and excessive production, leading to hyperglycemia. The global prevalence of diabetes is rising, with projections indicating it will affect 783.2 million people by 2045. Insulin treatment is crucial, especially for type 1 diabetes, due to the lack of β-cell function. Intensive insulin therapy, involving multiple daily injections or continuous subcutaneous insulin infusion, has proven effective in reducing microvascular complications but poses a higher risk of severe hypoglycemia. Recent advancements in insulin formulations and delivery methods, such as ultra-rapid-acting analogs and inhaled insulin, offer potential benefits in terms of reducing hypoglycemia and improving glycemic control. However, the traditional subcutaneous injection method has drawbacks, including patient compliance issues and associated complications. Nanomedicine presents innovative solutions to these challenges, offering promising avenues for overcoming current drug limitations, enhancing cellular uptake, and improving pharmacokinetics and pharmacodynamics. Various nanocarriers, including liposomes, chitosan, and PLGA, provide protection against enzymatic degradation, improving drug stability and controlled release. These nanocarriers offer unique advantages, ranging from enhanced bioavailability and sustained release to specific targeting capabilities. While oral insulin delivery is being explored for better patient adherence and cost-effectiveness, other nanomedicine-based methods also show promise in improving delivery efficiency and patient outcomes. Safety concerns, including potential toxicity and immunogenicity issues, must be addressed, with the FDA providing guidance for the safe development of nanotechnology-based products. Future directions in nanomedicine will focus on creating next-generation nanocarriers with precise targeting, real-time monitoring, and stimuli-responsive features to optimize diabetes treatment outcomes and patient safety. This review delves into the current state of nanomedicine for insulin delivery, examining various types of nanocarriers and their mechanisms of action, and discussing the challenges and future directions in developing safe and effective nanomedicine-based therapies for diabetes management.

The Efficiency of an Advanced Hybrid Closed Insulin Pump in Patients with Type 1 Diabetes for Improved Blood Glucose Control

Abstract Background Diabetes technology, especially advanced hybrid closed-loop (AHCL) systems, is rapidly advancing, offering improved glycemic control, reduced hypoglycemia, and reduced treatment burden for patients with type 1 diabetes (T1D). This study aimed to evaluate the clinical efficiency of an AHCL system—the Medtronic MiniMed 780G insulin pump combined with continuous glucose monitoring—among individuals with T1D in real-world clinical settings. Methods In an observational retrospective study, we identified a cohort of 41 patients (mean age, 47.1 ± 13.7 years; T1D duration, 23.6 ± 13 years; 73.2% female) previously using an insulin pump or those on multiple daily insulin injections, currently using the AHCL system for at least 6 months. Primary outcomes were the changes of the following parameters, before AHCL initiation and at 6 months after treatment; (1) time in range (TIR): time with glucose levels in the range of 70 to 180 mg/dL, (2) time below range (TBR): time with glucose levels below 70 mg/dL, and (3) time above range (TAR): time with glucose levels above 180 mg/dL. Results Data analysis from 41 patients showed a significant 16.5% ± 13.8% increase in TIR (from 56.6 ± 17.9 to 73.1 ± 10.6%, p &lt; 0.001). Both TBR and TAR decreased by 2.9 ± 4.8% (p = 0.004) and 13.6 ± 16.4% (p &lt; 0.001), respectively. Mean glucose concentration, coefficient of variation, and glucose management indicator significantly improved. Conclusion The AHCL system effectively improved glucose control regarding TIR, TBR, and TAR. Enhanced glycemic control metrics highlight the potential for wider adoption of AHCL technology.

Effect of Crocus sativus Extract Supplementation in the Metabolic Control of People with Diabetes Mellitus Type 1: A Double-Blind Randomized Placebo-Controlled Trial.

61 individuals with DMT-1, mean age 48 years old (48.3 ± 14.6), 26 females (42.6%) were randomized to receive a new oral supplement in sachets containing probiotics, prebiotics, magnesium, and Crocus sativus L. extract or placebo containing probiotics, prebiotics and magnesium daily for 6 months. Glycemic control was assessed with a continuous glucose monitoring system and laboratory measurement of HbA1c and lipid profile was also examined. Blood pressure at baseline and end of intervention was also measured. Individuals were either on a continuous subcutaneous insulin infusion with an insulin pump or in multiple daily injection regimens. Diabetes distress and satiety were assessed through a questionnaire and body composition was assessed with bioelectrical impedance. At the end of the intervention, the two groups differed significantly only in serum triglycerides (p = 0.049). After 6 months of treatment, a significant reduction in the active group was observed in glycated hemoglobin (p = 0.046) and serum triglycerides (p = 0.021) compared to baseline. The other primary endpoints (glycemic control, lipid profile, blood pressure) did not differ within the groups from baseline to end of intervention, and there was no significant difference between the two groups. Diabetes distress score improved significantly only in the active group (p = 0.044), suggesting an overall improvement in diabetes disease burden in these individuals but that was not significant enough between the two groups. A probiotic supplement with saffron extract improves serum triglycerides in well-controlled people with DMT-1 and may potentially be a valuable adjunct for enhancing glycemic control.

Retinal Perfusion Analysis of Children with Diabetes Mellitus Type 1 Using Optical Coherence Tomography Angiography.

(1) Background: This study aims to evaluate retinal perfusion by optical coherence tomography angiography (OCTA) in pediatric patients with type 1 diabetes mellitus (T1D) without diabetic retinopathy (DR). (2) Methods: Thirty-one patients affected by T1D were enrolled. All participants were evaluated using OCTA. The foveal avascular zone (FAZ) and superficial and deep macular vessel density (VD) were analyzed. The correlation of these parameters with metabolic factors such as body mass index (BMI), glycated hemoglobin (HbA1c), and the type of insulin therapy (multiple daily injections, MDI vs. continuous subcutaneous insulin infusion, CSII) was determined. (3) Results: None of the OCTA parameters were significantly different between the groups. The patients' HbA1C level did not influence any of the OCTA parameters. The use of MDI tended to reduce the parafoveal and perifoveal deep VD (p = 0.048 and p = 0.021, respectively) compared to CSII. An elevated BMI tended to increase the deep macular (p = 0.005) and perifoveal VD (p = 0.006). (4) Conclusion: VD and FAZ are normal in pubescent children with T1D without signs of DR. Treatment with CSII may be a better choice compared to MDI, as CSII may be protective against retinal microvascular damage. Our results indicate the need for new clinical parameters of glycemic control in addition to HbA1c which could assess the risk of DR.

Partial Clinical Remission of Type 1 Diabetes in Swedish Children: A Longitudinal Study from the Swedish National Quality Register (SWEDIABKIDS) and the Better Diabetes Diagnosis (BDD) Study.

Aims/Hypotheses: To investigate the frequency and characteristics of partial remission in Swedish children with type 1 diabetes and whether the insulin delivery method, that is, continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDIs), affects incidence and duration of this period, 2007-2011. Factors that increase the proportion of subjects who enter partial remission and extend this period can improve long-term metabolic control and reduce the risk of severe hypoglycemia, improve quality of life, and, in the long run, reduce late complications. Methods: Longitudinal data from 2007 to 2020 were extracted from the Swedish National Quality Register (SWEDIABKIDS) with all reported newly diagnosed children. Data on C-peptide from the participants in the Better Diabetes Diagnosis study from 2007 to 2010 were used. The definition of partial remission was insulin dose-adjusted HbA1c: HbA1c (%) + [4 × total daily insulin dose (U/kg/day)] ≤9. Results: Of the 3887 patients, 56% were boys. More boys than girls were in partial remission throughout the follow-up period until 24 months after diabetes onset. Fewer children 0-6 years old had partial remission at 3 and 12 months but not at 24 months compared with older age-groups. A larger proportion of patients using CSII at 12 and 24 months remained in partial remission compared with those with MDI (37% vs. 33%, P = 0.02 and 31% vs. 27%, P = 0.01, respectively). The level of C-peptide was higher in the group with partial remission and mean HbA1c was lower (both P < 0.001). Partial remission at 12 months after diabetes onset was associated with CSII (odds ratio [OR]: 1.39, confidence interval [CI]:1.13, 1.71), shorter diabetes duration (OR: 0.80, CI: 0.76, 0.84), and male sex (OR: 1.23, CI: 1.04, 1.46). Conclusions/Interpretation: Insulin through MDI, longer duration of diabetes, and female sex were associated with lower frequency of partial remission. Use of CSII seems to contribute to longer partial remission among Swedish children with type 1 diabetes.

Comparative effects of insulin pump and injection on gestational diabetes mellitus pregnancy outcomes and serum biomarkers

BACKGROUND Insulin injection is the basic daily drug treatment for diabetic patients. AIM To evaluate the comparative impacts of continuous subcutaneous insulin infusion (CSII). METHODS Based on the treatment modality received, the patients were allocated into two cohorts: The CSII group and the multiple daily injections (MDI) group, with each cohort comprising 210 patients. Comparative assessments were made regarding serum levels of serum-secreted frizzled-related protein 5, homocysteine, and C1q/TNF-related protein 9. Furthermore, outcomes such as fasting plasma glucose, 2-hour postprandial glucose levels, pain assessment scores, and the incidence of complications were evaluated post-treatment. RESULTS The CSII group displayed notably lower fasting plasma glucose and 2-h postprandial glucose levels in comparison to the MDI group (P &lt; 0.05). Subsequent analysis post-treatment unveiled a significantly higher percentage of patients reporting no pain in the CSII group (60.00%) in contrast to the MDI group (36.19%) (P &lt; 0.05). Additionally, the CSII group exhibited a markedly reduced occurrence of fetal distress and premature rupture of membranes compared to the MDI group (P &lt; 0.05). However, there were no significant variances observed in other pregnancy outcomes between the two groups (P &gt; 0.05). A statistical analysis revealed a significant difference in the incidence of complications between the groups (χ 2 = 11.631, P = 0.001). CONCLUSION The utilization of CSII via an insulin pump, as opposed to MDI, can significantly enhance the management of insulin administration in patients with GDM by diversifying the sites of insulin delivery. This approach not only promotes optimal glycemic control but also regulates metabolic factors linked to blood sugar, reducing the likelihood of adverse pregnancy outcomes and complications. The clinical relevance and importance of CSII in GDM management highlight its wide-ranging clinical usefulness.

959-P: Multiple Daily Injection (MDI) to Automated Insulin Delivery (AID) vs. Non-AID Insulin Pump for Newly Diagnosed People with Type 1 Diabetes Offers Improvement in Glycemic Control

959-P: Multiple Daily Injection (MDI) to Automated Insulin Delivery (AID) vs. Non-AID Insulin Pump for Newly Diagnosed People with Type 1 Diabetes Offers Improvement in Glycemic Control

1056-P: Cost-Effectiveness of the MiniMed 780G System vs. Multiple Daily Injections (MDI) Used with the Dexcom G6 Continuous Glucose Monitoring (CGM) System

1056-P: Cost-Effectiveness of the MiniMed 780G System vs. Multiple Daily Injections (MDI) Used with the Dexcom G6 Continuous Glucose Monitoring (CGM) System

A cross-sectional questionnaire study: Impaired awareness of hypoglycaemia remains prevalent in adults with type 1 diabetes and is associated with the risk of severe hypoglycaemia.

Impaired awareness of hypoglycaemia (IAH) is a risk factor for severe hypoglycaemia (SH) in type 1 diabetes (T1D). Much of the IAH prevalence data comes from older studies where participants did not have the benefit of the latest insulins and technologies. This study surveyed the prevalence of IAH and SH in a tertiary adult clinic population and investigated the associated factors. Adults (≥18 years) attending a tertiary T1D clinic completed a questionnaire, including a Gold and Clarke score. Background information was collected from health records. 189 people (56.1% female) with T1D (median [IQR] disease duration 19.3 [11.5, 29.1] years and age of 41.0 [29.0, 52.0] years) participated. 17.5% had IAH and 16.0% reported ≥1 episode of SH in the previous 12 months. Those with IAH were more likely to report SH (37.5% versus 11.7%, p = 0.001) a greater number of SH episodes per person (median [IQR] 0 [0,2] versus 0 [0,0] P<0.001) and be female (72.7% versus 52.6%, p = 0.036). Socio-economic deprivation was associated with IAH (p = 0.032) and SH (p = 0.005). Use of technology was the same between IAH vs aware groups, however, participants reporting SH were more likely to use multiple daily injections (p = 0.026). Higher detectable C-peptide concentrations were associated with a reduced risk of SH (p = 0.04). Insulin pump and continuous glucose monitor use was comparable in IAH versus aware groups. Despite this, IAH remains a risk factor for SH and is prevalent in females and in older people. Socioeconomic deprivation was associated with IAH and SH, making this an important population to target for interventions.

745-P: Effects of Liraglutide on GLP-1, GIP, and Glucagon Concentrations in Persons with Type 2 Diabetes with Multiple Daily Insulin Injections during a 24-Week Period

745-P: Effects of Liraglutide on GLP-1, GIP, and Glucagon Concentrations in Persons with Type 2 Diabetes with Multiple Daily Insulin Injections during a 24-Week Period

MDI versus CSII in Chinese adults with type 1 diabetes in a real-world situation: based on propensity score matching method

BackgroundCompared with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII) is significantly more expensive and has not been widely used in Chinese type 1 diabetes mellitus (T1DM) patients. So there are still significant knowledge gaps regarding clinical and patient-reported outcomes in China.AimsThis study aims to compare the glycated hemoglobin (HbA1C), insulin therapy related quality of life (ITR-QOL), fear of hypoglycemia (FOH) of adult T1DM patients treated with MDI and CSII based on propensity score matching in real-world conditions in China.MethodsFour hundred twenty adult T1DM patients who were treated with MDI or CSII continuously for more than 12 months in a national metabolic center from June 2021 to June 2023 were selected as the study subjects. Their QOL and FOH were evaluated with Insulin Therapy Related Quality of Life Measure Questionnaire-Chinese version (ITR-QOL-CV) and the Chinese Version Hypoglycemia Fear Survey-Worry Scale (CHFSII-WS), and their HbA1C were collected at the same time. Potential confounding variables between the two groups were matched using propensity score matching.ResultsOf the 420 patients included in the study, 315 were in MDI group and 105 were in CSII group. 102 pairs were successfully matched. After matching, the total score of ITR-QOL-CV scale in CSII group was significantly higher than that in MDI group (87.08 ± 13.53 vs. 80.66 ± 19.25, P = 0.006). Among them, the dimensions of daily life, social life, and psychological state were all statistically different (P < 0.05). The scores of CHFSII-WS (8.33 ± 3.49 vs. 11.77 ± 5.27, P = 0.003) and HbA1C (7.19 ± 1.33% vs. 7.71 ± 1.93%, P = 0.045) in CSII group were lower than those in MDI group.Conclusions25.0% of T1DM adults are treated with CSII. Compared with adult T1DM patients treated with MDI, those treated with CSII have higher ITR-QOL, less FoH, and better control of HbA1C in real-world conditions in China. Therefore, regardless of economic factors, CSII is recommended for adult T1DM patients to optimize the therapeutic effect and outcomes.

Diabetes Technology and Waste: A Real-World Study in a Specialized Practice in Germany.

Diabetes technology is a fundamental part of modern diabetes therapy. Its widespread usage is associated with an increasing amount of "diabetes technology waste." The aim of this study was to quantify this waste in a real-world situation in a specialized diabetes practice in Germany. Eighty patients with diabetes and insulin treatment participated and collected all of their therapy-associated waste for three months. Their attitude toward sustainability of antidiabetic therapy, waste generation, and their own waste reduction/separation behavior was surveyed. In total, 23 707 pieces of therapy-associated waste were collected. They comprised 5362 test strips, 630 glucose sensors, 14 619 needles, 519 insulin cartridges, 599 pens, and 1463 pieces of aids for insulin pump therapy. Type and quantity of the collected waste depended on the type of diabetes and the respective therapy, ie, multiple daily injections, usage of glucose sensors, or pump therapy. Most participants (92%) were surprised by the amounts of waste and reported an increased awareness toward the resource consumption of their therapy (87%). The survey indicated an enhanced interest in waste separation (94%) and a demand for the reduction and recycling of devices/aids (93%). Our data revealed the amount and complexity of the waste generated by modern diabetes therapy. Extrapolating these data, it can be estimated that around 1.2 billion pieces of diabetes technology waste are generated in Germany per year. The major concern of the study participants was the limited number of recycling options. A clear demand for improved sustainability of the medical products was expressed.

Time In Tight Range in children and adolescents with type 1 diabetes: A cross-sectional observational single centre study evaluating efficacy of new advanced technologies.

Early and tight glycaemic control is crucial to prevent long-term complications of Type 1 Diabetes (T1D). The aim of our study was to compare glucose metrics, including Time In Tight Range (TITR), in a real-world setting. We performed a single-centre cross-sectional study in 534 children and adolescents with T1D. Participants were divided into four groups (multiple daily injections+real-time Continuous glucose monitoring (CGM), multiple daily injections+intermittently scanned CGM, sensor augmented pump (SAP), and Advanced Hybrid Closed-Loop (AHCL). Demographical and clinical data were collected and analysed. The group with AHCL showed significantly higher Time In Range (TIR) (71.31%±10.88) than SAP (57.82%±14.98; p<0.001), MDI+rtCGM (54.56%±17.04; p<0.001) and MDI+isCGM (52.17%±19.36; p<0.001) groups with a lower Time Above Range (p<0.001). The group with AHCL also showed lower Time Below Range than MDI+isCGM and SAP groups (p<0.01). The overall TITR was 37%±14 with 19% of participants who reached a TITR ≥50% with a mean TIR of 81%. AHCL had significantly higher TITR (45.46%±11.77) than SAP (36.25%±13.53; p<0.001), MDI+rtCGM (34.03%±13.89; p<0.001) and MDI+isCGM (33.37%±15.84; p<0.001) groups with a lower Coefficient of Variation (p<0.001). Our study indicates that AHCL ensures a better glycaemic control with an improvement in both TIR and TITR, along with a reduction in CV. Implementation of automated insulin delivery systems should be considered in the treatment of children and adolescents with T1D.

Neonatal outcomes in women with diabetes mellitus — analysis of DAPSY data

BACKGROUND: Hyperglycemia in pregnancy is associated with short- and long-term implications for children. Nevertheless, the effects of different types of diabetes mellitus and treatment methods on the neonatal outcomes are to be investigated. AIM: The aim of this study was to evaluate the contribution of different types of maternal diabetes mellitus to the risk of adverse neonatal outcomes. MATERIALS AND METHODS: This retrospective cohort study included women (n = 3261) who delivered at the Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott, Saint Petersburg, Russia in 2008–2017. The following comparison groups were used: type 1 diabetes mellitus (n = 506; 1a, continuous subcutaneous insulin injections; 1b, multiple daily insulin injections), type 2 diabetes mellitus (n = 229; 2a, diet; 2b, insulin therapy), gestational diabetes mellitus (n = 2387; 3a, diet; 3b, insulin therapy), and control (n = 139). The main birth outcomes assessed included weight and length of newborns, Apgar score at birth and at 5 minutes after birth, and pathological conditions such as fetal macrosomia, syndrome of infant of mother with gestational diabetes mellitus or diabetic mother (P70.0–P70.1), light (P05.0) or small for gestational age (P05.1), intrauterine growth restriction, prematurity (P07), neonatal hypoglycemia (P70.4), and neonatal respiratory distress syndrome (P22). The secondary birth outcomes assessed included birth trauma (P10–P15), stillbirth (P95), disturbances of cerebral status of newborn (P91), and congenital malformations, deformations and chromosomal abnormalities (Q00–Q99). RESULTS: Pregestational diabetes mellitus is strongly associated with adverse neonatal outcomes. Type 1 diabetes mellitus women had the highest risks for fetal macrosomia and diabetic fetopathy, neonatal hypoglycemia, prematurity, and congenital malformations (odds ratio 3.54, 20.2, 5.59, 4.24 and 3.92 respectively). In type 2 diabetes mellitus patients, the risks of low birth weight, intrauterine growth restriction and birth trauma (odds 9.14, 5.42 and 6.3 respectively) were higher. For women with gestational diabetes mellitus, these risks were lower. CONCLUSIONS: This study provides a comprehensive analysis of the major neonatal pathology in patients with different types of diabetes mellitus, taking into account the treatment method. Preconception care and optimal glycemic control are necessary to reduce the risk of obstetric and perinatal complications in women with pregestational types of diabetes mellitus. Further research into the health status of this cohort of children at a later age is required.

Addressing the Burden of Multiple Daily Insulin Injections in Type 2 Diabetes with Insulin Pump Technology: A Narrative Review.

The growing prevalence of type 2 diabetes (T2D) remains a leading health concern in the US. Despite new medications and technologies, glycemic control in this population remains suboptimal, which increases the risk of poor outcomes, increased healthcare resource utilization, and associated costs. This article reviews the clinical and economic impacts of suboptimal glycemic control in patients on basal-bolus insulin or multiple daily injections (MDI) and discusses how new technologies, such as tubeless insulin delivery devices, referred to as "patch pumps", have the potential to improve outcomes in patients with T2D.

Efficacy and safety of advanced hybrid closed loop systems in children with type 1 diabetes younger than 6 years.

Tight glycemic control is essential for the normal growth and development of preschool children. The aim of our study was to evaluate the impact of advanced hybrid closed loop (AHCL) systems in a real-life setting in children younger than 6 years. We conducted a two-center prospective study. We enrolled 19 patients with a median age at disease onset of 2.6 years [interquartile range (IQR) 1.6; 4.4] and a median disease duration of 1.4 years (IQR 0.9; 2.8) who were switched to AHCL from multiple daily injections or open-loop insulin therapy and with a 6-month follow-up. Clinical data, sensor glycemic metrics, and pump settings were collected and analyzed. After 6 months of follow-up, there was a significant reduction in median HbA1c (p = 0.0007) and glucose management indicator (p = 0.03). A reduction in both mild (>180 mg/dL) (p = 0.04) and severe (>250 mg/dL) (p = 0.01) hyperglycemia was observed after 1 month of auto mode, and in mild hyperglycemia, it persisted up to 6 months (p = 0.02). A small increase in time below range (<70 mg/dL) was observed (p = 0.04) without a significant difference in time <54 mg/dL (p = 0.73). Time in range increased significantly, reaching a 10% increment (p = 0.03) compared with baseline. A significant reduction in the average sensor glucose was observed (p = 0.01) while coefficient of glucose variability (CV%) remained stable (p = 0.12). No episodes of ketoacidosis or severe hypoglycemia have been recorded. AHCL systems are effective and safe for children younger than 6 years and should be considered as a valid therapeutic option from diabetes onset.

Efficacy and Safety of Insulin Pump Therapy in Children and Adolescents with Type 1 Diabetes Mellitus

Continuous subcutaneous insulin infusion (CSII) pump represents a treatment option that can aid in achieving an important goal to reduce the most frequent complications associated with treatment; hypoglycemic and hyperglycemic episodes, which have also a great impact on life quality of patients. This study was conducted to report the effect and safety of insulin pump therapy on glycemic control, hypoglycemia and diabetic ketosis (DKA) rates in Libyan type 1 diabetic (T1D) patients. A descriptive and retrospective study which included patients treated and followed up at Tripoli University Hospital. Fifty-seven T1D patients used CSII pump enrolled in this study. Assessment of hypoglycemia, DKA, measuring the glycosylated hemoglobin (HbAlc) values at time of diagnosis (prior to CSII) and at time of study conduction. Mean age was 12.72 year ± 3.8 SD. Mean duration of diabetes was 7.28 years ± 3.9 SD. The baseline mean HbA1c was 8.58 ± 1.73% during Multiple Daily Injections (MDI) at pre-pump and 7.76 ± 1.33% post initiation of CSII (p = 0.001), with higher proportion of patient’s post-pump treated had good metabolic control with HbA1c compared to pre-pump infusion 23, 40.4% and 16, 28.1%, respectively. Both the incidence of ketoacidosis and severe hypoglycemic episodes was improved compared with MDI pre-pump significantly during CSII (P&lt;0.001). This study supports that CSII is an effective alternative in managing T1DM. In addition, therapy with insulin pump in children with diabetes is very efficient and safe with obvious reduction of HbA1c and significantly diminished rates of DKA and hypoglycemia.

Which Diabetes Patients Will Benefit the Most from Once-Weekly Basal Insulin Analogs? A Review with a Special Focus on Type 1 Diabetes Patients

Basal insulin analogs, typically administered once or twice daily, have been one of the two pillars of the multiple daily injection (MDI) insulin therapy of patients with type 1 diabetes (T1D) for the last twenty years. Recently, once-weekly basal insulin analogs have been developed and are in late-phase clinical trials. One of these analogs is insulin icodec (icodec), appropriately developed to bind reversibly to albumin and to be gradually released into the patient’s circulation. Icodec has been tried mostly in clinical trials of adult patients with type 2 diabetes. A recent phase 3a clinical trial comprising adult patients with T1D was designed to evaluate icodec’s efficacy and safety compared with a daily basal insulin analog (degludec) after a 26-week main phase plus a safety extension of another 26 weeks. Icodec showed non-inferiority to once-daily degludec in glycated hemoglobin (HbA1c) reduction at week 26, and no significant differences in time in range (TIR) (70–180 mg/dL) and in time above range (TAR) (&gt;180 mg/dL). On the other hand, it was associated with increased rates of clinically significant hypoglycemia (blood glucose &lt; 54 mg/dL) and severe hypoglycemia (external assistance need for recovery), remaining either below or close to the internationally recommended targets for hypoglycemia. Another once-weekly insulin analog, basal insulin Fc (BIF), has been investigated in a phase 2 clinical trial comprising adult patients with T1D, with equally promising results. These preliminary data suggest that once-weekly insulin analogs could be of use for some patients with T1D, for example, patients not taking insulin regularly or those who are on MDI and wish for fewer injections. In addition, due to its prolonged mode of action, it could decrease the risk of diabetic ketoacidosis and the need for hospitalization. Additionally, patients with T1D that struggle with wearing diabetes mellitus devices/closed-loop insulin pumps either due to the cost or due to skin issues may also benefit from long-acting insulin. There is increasing evidence of the benefits of adjunctive therapies to insulin in T1D patients, but these therapies are not FDA-approved due to a possible higher risk of diabetic ketoacidosis. These long-acting insulin analogues could be used with adjunctive therapies in selected patients. This review aims to present available data on the mode of action, clinical trial results, and possible benefits of once-weekly insulin analogs for patients with T1D. In addition, it intends to suggest a future research framework for important clinical questions, such as once-weekly insulin analog use and exercise, sick days, or surgery, that will enhance our knowledge regarding this indisputable innovation in insulin management.