Clinical perspective on innovative insulin delivery technologies in diabetes management.

Introduction: The primary objective of this study is to report the results of an online questionnaire and the in-person discussion sessions of physicians specializing in diabetes care in which their opinions about current diabetes management was obtained. Methods: The Diabetes Innovation Summit 2023 drew attendance from a diverse group of specialized physicians from multiple countries. A comprehensive literature review was conducted to examine the technologies and medical needs associated with diabetes management. Using the results of the review, a questionnaire was developed by three experts from the steering committee to solicit feedback from specialized physicians. The online survey was made accessible between 10th December 2022 and 10th January 2023. Following the online survey, six structured in-person discussion sessions were conducted with specialized physicians from the Middle East, Central-Eastern Europe, and North Africa regions. Results: The study revealed that about 59% of survey requests were answered, with many participants being pediatric endocrinologists from North Africa. Around 60% of diabetes patients followed Multiple Daily Injections (MDI) according to specialized physicians. Among MDI users, 62% employed Blood Glucose Monitors (BGM), 31% used intermittent-scanning Continuous Glucose Monitors (isCGM), and 23% used CGM. In North Africa, nearly 90% of patients used MDI due to financial constraints. While physicians focused on both Time in Range (TIR) and HbA1c for MDI-treated patients, satisfaction with TIR achieved was expressed by 31%, while 74·1% believed Real-Time CGM (rtCGM) was effective. Concerns arose about potentially misleading HbA1c results and the relatively low patient achievement of target TIR despite CGM usage. The Smart MDI System was seen favorably compared to other applications. The system's affordability was a significant barrier, particularly in the Middle East and Africa. Conclusion: The present study highlights that physicians are generally supportive of utilizing new technology. The questionnaires and the open discussion revealed the expectation that the Smart MDI technology provides better control, primarily by identifying missed boluses, while expressing concerns on the use of the technology by teenagers and children, who might forget the device and be reluctant to use in public, and by the older population, who might be challenged by the technology.

Impact of continuous glucose monitoring on hospitalizations and glucose control in people with type 2 diabetes: real-world analysis.

AIM: The real-world benefits of continuous glucose monitoring (CGM) in the broad type 2 diabetes (T2D) population are not well studied. Our study evaluated the impact of CGM use on health care resource utilization over 12 months in adults with T2D. MATERIALS AND METHODS: This retrospective cohort analysis used Optum's de-identified Market Clarity data of >79 million people to evaluate CGM use in people with T2D who were treated with non-insulin (NIT), basal insulin (BIT) and prandial insulin therapy (PIT). The primary outcomes were changes in all-cause hospitalizations, acute diabetes-related hospitalizations and acute diabetes-related emergency room visits during the 6- and 12-month post-index period following transition from blood glucose monitoring to CGM. A pre-specified subgroup analysis assessed glucose control and medication changes among people with T2D over 1 year. RESULTS: The analysis included 74 679 adults with T2D (NIT; n = 25 269), (BIT; n = 16 264) and (PIT; n = 33 146). Significant reductions in all-cause hospitalizations, acute diabetes-related hospitalizations and acute diabetes-related emergency room visits were observed in the 6-month post-index period that were sustained during the 6-12 month post-index period (NIT, -10.1%, -31.0%, -30.7%; BIT, -13.9%, -47.6%, -28.2%; and PIT, -22.6%, -52.7%, -36.6%, respectively). A subgroup analysis of 6030 people showed mean glycated haemoglobin reductions at approximately 3 months, which were also sustained throughout the post-index period: NIT, -1.1 (0.05)%; BIT, -1.1 (0.06)%; and PIT, -0.9 (0.04)%, p < 0.0001. CONCLUSIONS: CGM use in real-life across different therapeutic regimens in adults with T2D was associated with reductions in health care resource utilization with improved glucose control over 1 year.

Refining Insulin on Board with netIOB for Automated Insulin Delivery.

Automated insulin delivery (AID) systems enhance glucose management by lowering mean glucose level, reducing hyperglycemia, and minimizing hypoglycemia. One feature of most AID systems is that they allow the user to view "insulin on board" (IOB) to help confirm a recent bolus and limit insulin stacking. This metric, along with viewing glucose concentrations from a continuous glucose monitoring system, helps the user understand bolus insulin action and the future "threat" of hypoglycemia. However, the current presentation of IOB in AID systems can be misleading, as it does not reflect true insulin action or automatic, dynamic insulin adjustments. This commentary examines the evolution of IOB from a bolus-specific metric to its contemporary use in AID systems, highlighting its limitations in capturing real-time insulin modulation during varying physiological states.

Association of continuous subcutaneous insulin therapy and diabetic retinopathy in type 1 diabetes: A national cohort study.

AIM: This study aimed to investigate the short-and long-term effect on diabetic retinopathy (DR) in individuals with type 1 diabetes treated with continuous subcutaneous insulin injections (CSII) compared to those using multiple daily injections (MDI). METHODS: We conducted a register-based matched cohort study utilizing data from the Danish Registry of Diabetic Retinopathy as well as several other national Danish health registers. Our cohort consisted of all individuals with type 1 diabetes who attended the Danish screening program for DR from 2013 to 2022. We included individuals registered with CSII treatment, and compared them to individuals using MDI, matched by age, sex, and DR level. Cox regression analysis was performed to evaluate the outcomes. RESULTS: The study included 674 individuals treated with CSII and 2006 matched MDI users. In our cohort 53.4 % were female and median age was 36 (IQR 27-47). Average follow-up risk-time was 4.8 years. There was no difference in the risk of DR worsening between the CSII group and MDI group (HR 1.05 [95%CI 0.91; 1.22], p = 0.49). However, an increased risk of focal photocoagulation was observed in the CSII group (HR 2.40 [95%CI 1.11; 5.19], p = 0.03). CONCLUSIONS: Our findings indicate that CSII treatment does not confer a significant difference in the overall short- and long-term risk of DR worsening or ocular intervention compared to MDI treatment. These results provide insights into the DR outcomes of CSII treatment in individuals 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 < 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 < 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 < 0.05). However, there were no significant variances observed in other pregnancy outcomes between the two groups (P > 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.

The IDEAL (Insulin therapy DE-intensificAtion with iglarLixi) Randomised Controlled Trial-Study Design and Protocol.

INTRODUCTION: Multiple daily injection insulin regimen (MDI) represents the most intensive insulin regimen used in the management of people with type 2 diabetes (PwT2D). Its efficacy regarding glycaemic control is counterbalanced by the increased risk of hypoglycaemia, frequently observed tendency to weight gain and necessity for frequent glucose monitoring. Recent introduction of novel antidiabetic medications with pleiotropic effects reaching far beyond the reduction of glycaemia (HbA1c), such as the glucagon-like peptide 1 receptor agonist (GLP-1 RA), has significantly widened the therapeutic options available for management of T2D. Consequently, there is currently a substantial number of PwT2D for whom the MDI regimen was initiated at a time when no other options were available. Yet, in present times, these individuals could benefit from simplified insulin regimens ideally taking advantage of the beneficial effects of the novel classes of antidiabetic medications. iGlarLixi (Suliqua®) is a once-daily fixed-ratio combination of basal insulin analogue glargine 100 U/ml and a GLP-1 RA lixisenatide. METHODS: Insulin therapy DE-intensificAtion with iglarLixi (IDEAL) is a six-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active treatment period examining the efficacy and safety of MDI regimen de-intensification with once-daily administration of iGlarLixi versus MDI regimen continuation in PwT2D on a backgroud therapy with metformin ± sodium-glucose cotransporter 2 inhibitor. PLANNED OUTCOMES: The primary objective is to compare the effects of MDI therapy de-intensification with iGlarLixi versus MDI regimen continuation regarding glycaemic control (HbA1c). Secondary objectives include detailed evaluation of the effects of MDI regimen de-intensification with iGlarLixi on glycaemic control using standardised continuous glucose monitoring (CGM) metrics and self-monitoring of plasma glucose. Furthermore, body weight and body composition analysis, quality of life and safety profile are evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT04945070.

Differences in Glycemic Control for Inpatients with Type 1 Diabetes on Insulin Pump Versus Subcutaneous Insulin Therapy.

BACKGROUND: Inpatient use of insulin pump therapy has been increasing due to greater availability of this technology, however there is a paucity of research that investigates glycemic control of inpatient insulin pump users. OBJECTIVE: To compare the glycemic control of hospitalized patients with type 1 diabetes (T1D) who used insulin pump vs. multiple daily injections (MDI). DESIGN: Retrospective chart review. PARTICIPANTS: Patients with T1D who were hospitalized between January 1, 2017, and December 31, 2019, in an academic medical center in the New York metropolitan area. MAIN MEASURES: Patients were categorized into three groups based on their method of insulin administration: "pump only" group used insulin pump exclusively, "MDI only" group used MDI only, and "intermittent pump" group used a combination of both methods. The primary endpoints are mean blood glucose, rates of hypoglycemic events (blood glucose < 70 mg/dL), and rates of hyperglycemic events (blood glucose > 250 mg/dL). Separate multivariable Poisson regressions were performed to determine the association between the type of insulin administration and rate outcomes (i.e., rate of hypoglycemic events and rate of hyperglycemic events). RESULTS: The study included 78 patients with a mean age of 51, who were mostly male (54%), and white (72%). The average proportion of glucose measurements that were hyperglycemic for the "pump only", "MDI only", and "intermittent pump" groups were 0.11 (SD = 0.11), 0.25 (SD = 0.19), and 0.24 (SD = 0.25), respectively. The "pump only" group has a significantly lower proportion of hyperglycemic events as compared to the "MDI only" group (p = 0.0227). CONCLUSIONS: In this sample, patients who exclusively used their insulin pump while inpatient had a lower rate of hyperglycemic events than patients who used MDI only; suggesting that select patients can safely continue their insulin pump therapy in the inpatient setting.

A Randomized Clinical Trial for Meal Bolus Decision Using Learning-based Control in Adults With Type 2 Diabetes.

CONTEXT: We propose an artificial-pancreas-like algorithm (AP-A) that could automatically determine the preprandial insulin dose based on intermittently scanned continuous glucose monitoring (isCGM) data trajectories in multiple dose injection (MDI) therapy. OBJECTIVE: We aim to determine whether preprandial insulin dose adjustments guided by the AP-A are as effective and safe as physician decisions. METHODS: We performed a randomized, single-blind, clinical trial at a tertiary, referral hospital in Beijing, China. Type 2 diabetes participants were eligible if they were aged 18 years or older, with a glycated hemoglobin A1c of 8.0% or higher. Eligible participants were randomly assigned (1:1) to the AP-A arm supervised by physician and the conventional physician treatment arm. The primary objective was to compare percentage time spent with sensor glucose level in 3.9 to 10.0 mmol/L (TIR) between the 2 study arms. Safety was assessed by the percentage time spent with sensor glucose level below 3.0 mmol/L (TBR). RESULTS: A total of 140 participants were screened, of whom 119 were randomly assigned to the AP-A arm (n = 59) or physician arm (n = 60). The TIR achieved by the AP-A arm was statistically noninferior compared with the control arm (72.4% [63.3%-82.1%] vs 71.2% [54.9%-81.4%]), with a median difference of 1.33% (95% CI, -6.00 to 10.94, noninferiority margin -7.5%). TBR was also statistically noninferior between the AP-A and control arms (0.0% [0.0%-0.0%] vs 0.0% [0.0%-0.0%]), respectively; median difference (95% CI, 0.00% [0.00%-0.00%], noninferiority margin 2.0%). CONCLUSION: The AP-A-supported physician titration of preprandial insulin dosage offers noninferior glycemic control compared with optimal physician care in type 2 diabetes.

Effectiveness of Insulin Pump Therapy Versus Multiple Daily Injections for Glycemic Control and Rate of Diabetic Ketoacidosis Among Children With Type 1 Diabetes Mellitus.

Background Advances in pump technology and the availability of insulin analogs, as well as the results of the Diabetes Control and Complications Trial (DCCT), which established the benefit of improved glycemic control, have all contributed to the increased use of insulin pump therapy in recent years, particularly in children. Purpose This research aims to compare the impact of insulin delivery method, i.e., continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) on glycemic control and the rate of diabetic ketoacidosis (DKA) among children with type 1 diabetes mellitus in Al Ahsa, Saudi Arabia. Methods  A retrospective cohort study was carried out in a diabetic center in Al Ahsa, Saudi Arabia, over 24 months (2020-2022) among children with type I diabetes mellitus (age group 1-14 years). Results  In total, 351 patients with diabetes were induced, with 316 (90%) on MDI and 35 (10%) on CSII. After six months of diagnosis, precisely 38 (12%) of patients with diabetes on the MDI regimen experienced DKA, compared to 4 (11.4%) of those on the CSII regimen, with no statistically significant difference (P=0.918). At six months and nine months of follow-up, the average hemoglobin A1c (HbA1c) was considerably higher in diabetic patients on MDI (8.9 ± 1.7% vs. 8.2 ± 1.5% and 9.1 ± 1.6% vs. 8.0 ± 1.3%, respectively, with a significant p-value ≤0.05). Conclusion In this study, we found that patients on the MDI regimen had considerably higher HbA1c levels than patients on the CSII regimen, but there was no statistically significant difference in DKA rates between them. This is a short-term follow-up study, and we recommend that patients be followed for a longer period of time for further accurate outcomes.

The Hybrid Closed-Loop System Tandem t:slim X2™ with Control-IQ Technology: Expert Recommendations for Better Management and Optimization.

Technological advances in the management of diabetes, especially type 1 diabetes (T1D), have played a main role in significantly improving glycemic control of these patients in recent years. Undoubtedly, the most important advance has been the commercialization of hybrid closed-loop systems (HCL). Their effectiveness places them in the different guidelines from scientific societies as the gold standard for the treatment of people with T1D. However, obtaining the maximum performance from these systems requires a degree of expertise from the professionals who care for these patients. Specifically, the Tandem X2:slim with Control-IQ technology system, due to its features and configuration options and adjustments, allows T1D patients to better adapt the management of diabetes to multiple circumstances in their day-to-day life. It is necessary, however, to follow a systematic process to start the system and also for the subsequent follow-up, which allows its optimization in the shortest possible time. This expert recommendation reviews the main features of this HCL system, suggesting how to implement it and optimize its use after gaining experience treating many patients.

Combining uncertainty-aware predictive modeling and a bedtime Smart Snack intervention to prevent nocturnal hypoglycemia in people with type 1 diabetes on multiple daily injections.

OBJECTIVE: Nocturnal hypoglycemia is a known challenge for people with type 1 diabetes, especially for physically active individuals or those on multiple daily injections. We developed an evidential neural network (ENN) to predict at bedtime the probability and timing of nocturnal hypoglycemia (0-4 vs 4-8 h after bedtime) based on several glucose metrics and physical activity patterns. We utilized these predictions in silico to prescribe bedtime carbohydrates with a Smart Snack intervention specific to the predicted minimum nocturnal glucose and timing of nocturnal hypoglycemia. MATERIALS AND METHODS: We leveraged free-living datasets collected from 366 individuals from the T1DEXI Study and Glooko. Inputs to the ENN used to model nocturnal hypoglycemia were derived from demographic information, continuous glucose monitoring, and physical activity data. We assessed the accuracy of the ENN using area under the receiver operating curve, and the clinical impact of the Smart Snack intervention through simulations. RESULTS: The ENN achieved an area under the receiver operating curve of 0.80 and 0.71 to predict nocturnal hypoglycemic events during 0-4 and 4-8 h after bedtime, respectively, outperforming all evaluated baseline methods. Use of the Smart Snack intervention reduced probability of nocturnal hypoglycemia from 23.9 ± 14.1% to 14.0 ± 13.3% and duration from 7.4 ± 7.0% to 2.4 ± 3.3% in silico. DISCUSSION: Our findings indicate that the ENN-based Smart Snack intervention has the potential to significantly reduce the frequency and duration of nocturnal hypoglycemic events. CONCLUSION: A decision support system that combines prediction of minimum nocturnal glucose and proactive recommendations for bedtime carbohydrate intake might effectively prevent nocturnal hypoglycemia and reduce the burden of glycemic self-management.

Assessing Time in Range with Postprandial Glucose-Focused Titration of Ultra Rapid Lispro (URLi) in People with Type 1 Diabetes.

INTRODUCTION: To assess time in range (TIR) (70-180 mg/dL) with postprandial glucose (PPG)-focused titration of ultra rapid lispro (URLi; Lyumjev®) in combination with insulin degludec in people with type 1 diabetes (T1D). METHODS: This phase 2, single-group, open-label, exploratory study was conducted in 31 participants with T1D on multiple daily injection therapy. Participants were treated with insulin degludec and Lispro for an 11-day lead-in and then URLi for a 46-day treatment period consisting of 35-day titration and 11-day endpoint maintenance period. Glucose targets for the titration period were PPG < 140 mg/dL or < 20% increase from premeal, fasting glucose 80-110 mg/dL, and overnight excursion ± 30 mg/dL or less. Participants used the InPen™ bolus calculator and Dexcom G6 continuous glucose monitoring (CGM). RESULTS: Primary endpoint mean TIR (70-180 mg/dL) with URLi during the maintenance period was 70.2%. TIR (70-180 mg/dL) and times below/above range were not significantly different with URLi (maintenance) versus lispro (lead-in). HbA1c decreased from 7.1% at screening to 6.8% at endpoint (least squares mean [LSM] change from baseline, - 0.36%; P < 0.001). Fructosamine and 1,5-anhydroglucitol improved (P < 0.001). Mean hourly glucose using CGM was reduced from 8:00 AM to 4:00 PM with URLi. Overall highest PPG excursion across meals was significantly reduced at URLi endpoint compared with lispro lead-in (mean 56.5 vs 72.4 mg/dL; P < 0.001). Insulin-to-carbohydrate ratio (U/X g) was reduced (more insulin given) at breakfast at URLi endpoint vs lead-in (LSM 9.0 vs 9.7 g; P = 0.002) and numerically decreased at other meals. Total daily insulin dose (TDD) was higher at URLi endpoint compared with lispro lead-in (mean 50.2 vs 47.0 U; P = 0.046) with similar prandial/TDD ratio (mean 52.1% vs 51.2%). There were no severe hypoglycemia events during the study. CONCLUSIONS: URLi in a basal-bolus regimen focusing on PPG targets demonstrated improved overall glycemic control and reduced PPG excursions without increased hypoglycemia in participants with T1D. TRIAL REGISTRATION: ClinicalTrial.gov, NCT04585776.

Using Continuous Glucose Monitoring Values for Bolus Size Calculation in Smart Multiple Daily Injection Systems: No Negative Impact on Post-bolus Glycemic Outcomes Found in Real-World Data.

BACKGROUND: Recent evidence shows that it may be safe to estimate bolus sizes based on continuous glucose monitoring (CGM) rather than blood glucose (BG) values using glycemic trend-adjusted bolus calculators. Users may already be doing this in the real world, though it is unclear whether this is safe or effective for calculators not employing trend adjustment. METHODS: We assessed real-world data from a smart multiple daily injections (MDIs) device users with a CGM system, hypothesizing that four-hour post-bolus outcomes using CGM values are not inferior to those using BG values. Our data set included 184 users and spanned 18 months with 79 000 bolus observations. We tested differences using logistic regression predicting CGM or BG value usage based on outcomes and confirmed initial results using a mixed model regression accounting for within-subject correlations. RESULTS: Comparing four-hour outcomes for bolus events using CGM and BG values revealed no differences using our initial approach (P > .183). This finding was confirmed by our mixed model regression approach in all cases (P > .199), except for times below range outcomes. Higher times below range were predictive of lower odds of CGM-based bolus calculations (OR = 0.987, P < .0001 and OR = 0.987, P = .0276, for time below 70 and 54 mg/dL, respectively). CONCLUSIONS: We found no differences in four-hour post-bolus glycemic outcomes when using CGM or BG except for time below range, which showed evidence of being lower for CGM. Though preliminary, our results confirm prior findings showing non-inferiority of using CGM values for bolus calculation compared with BG usage in the real world.

Continuous Subcutaneous Infusion Versus Multiple Daily Injections of Insulin for Pregestational Diabetes in Pregnancy: A Systematic Review and Meta-Analysis.

BACKGROUND: The use of continuous subcutaneous insulin infusion (CSII) therapy in pregnancies affected by pregestational diabetes mellitus (DM) has generated mixed outcome data worthy of further investigation. This systematic review and meta-analysis aims to evaluate clinical outcomes associated with CSII versus multiple daily injections (MDIs) in pregnant persons with pregestational DM. METHODS: A predefined, systematic, librarian-assisted search of MEDLINE (PubMed), Embase, Cochrane Library, Scopus, ClinicalTrials.gov, and World Health Organization International Clinical Trial Registry Platform (published from 2010 to 2022) yielded 3003 studies describing pregnancy outcomes associated with CSII and/or MDI for pregestational DM. The primary exposure was mode of insulin administration, with cesarean delivery and neonatal hypoglycemia as the primary maternal and neonatal outcomes, respectively. Secondary outcomes included hypertensive disorders of pregnancy, first and third-trimester glycemic control, large-for-gestational age (LGA) neonate, preterm birth, neonatal intensive care unit admission, need for respiratory support, hyperbilirubinemia, 5-minute Apgar <7, shoulder dystocia, and perinatal mortality. We calculated pooled odds ratios (OR) with 95% confidence intervals (CI) using random-effects models. RESULTS: Among 39 eligible studies, 39% of the 5518 pregnancies included were exposed to CSII. Odds of cesarean delivery were higher with CSII (20 studies: 63% vs 56%, odds ratio [OR] 1.3 [95% confidence interval (CI) 1.2-1.5]), but we did not identify a difference in the odds of neonatal hypoglycemia (23 studies: 31% vs 34%, OR 1.1 [95% CI 0.9-1.5]). Among secondary outcomes, only the odds of LGA (20 studies: 47% vs 38%, OR 1.4 [95% CI 1.2-1.6]) were higher in individuals using CSII versus MDI. CONCLUSIONS: Use of CSII (vs MDI) for pregestational DM in pregnancy is associated with higher odds of cesarean delivery and delivery of an LGA neonate. Further evaluation of how CSII use may influence neonatal size and delivery route is warranted.

Maternal-fetal outcomes of pregnant women with type 1 diabetes treated with continuous subcutaneous insulin infusion or multiple daily injections during pregnancy - A Brazilian health care referral center cohort study.

Objective: Pregnant women with type 1 diabetes (T1D) have an increased risk of maternal-fetal complications. Regarding treatment, continuous subcutaneous insulin infusion (CSII) has advantages compared to multiple daily injections (MDI), but data about the best option during pregnancy are limited. This study's aim was to compare maternal-fetal outcomes among T1D patients treated with CSII or MDI during pregnancy. Subjects and methods: This study evaluated 174 pregnancies of T1D patients. Variables of interest were compared between the groups (CSII versus MDI), and logistic regression analysis was performed (p < 0.05). Results: Of the 174 included pregnancies, CSII was used in 21.3% (37) and MDI were used in 78.7% (137). HbA1c values improved throughout gestation in both groups, with no difference in the first and third trimesters. The frequency of cesarean section was significantly higher in the CSII group [94.1 vs. 75.4%, p = 0.017], but there was no significant difference in the frequency of other complications, such as miscarriage, premature delivery and preeclampsia. The mean birth weight and occurrence of neonatal complications were also similar, except for the proportion of congenital malformations, which was significantly lower in the CSII group [2.9 vs. 15.6%, p = 0.048]. In regression analysis, the association of CSII with cesarean section and malformations lost significance after adjusting for HbA1c and other covariates of interest. Conclusion: In this study, we observed a higher frequency of cesarean section and a lower occurrence of congenital malformations in the CSII group, but the adjusted results might indicate that these associations are influenced by glycemic control.

Nighttime hypoglycemia in Japanese children with type 1 diabetes mellitus treated with multiple daily injection insulin therapy.

Prevention of hypoglycemia is an important strategy for glycemic management in patients with type 1 diabetes mellitus (T1D). Hypoglycemia is difficult to recognize at night while sleeping, particularly when using multiple daily injection (MDI) insulin therapy rather than sensor-augmented insulin-pump therapy. Therefore, it is possible that patients with T1D are at higher risk of nocturnal hypoglycemia when insulin is administered using an MDI regimen. We investigated nocturnal hypoglycemia in 50 pediatric patients with T1D on MDI insulin therapy using data from an intermittently scanned continuous glucose monitoring (isCGM) system. Hypoglycemia was observed on 446 of the 1,270 nights studied. Most of the hypoglycemic episodes were severe (blood glucose <54 mg/dL). On nights when hypoglycemia occurred, the blood glucose concentrations measured using finger-stick blood glucose monitoring (FSGM) before sleep and the next morning were lower than nights when hypoglycemia did not occur. However, few values were below the normal blood glucose range, suggesting that FSGM alone may be insufficient to detect nocturnal hypoglycemia. Approximately 7% of time was spent below the normal glucose range during the 10 hours from 21:00 to 7:00 the next morning. This result suggests that the patients on MDI insulin therapy could end up spending more time in hypoglycemia than is recommended by the American Diabetes Association (time below range <4.0% of time per day). Monitoring glucose levels overnight using an isCGM sensor may improve glycemic management via automatic detection of blood glucose peaks and troughs.

[Depressive symptoms and insulin pump therapy in people with type 1 diabetes mellitus: A systematic review].

Type 1 Diabetes mellitus (T1DM) is a chronic, multifactorial metabolic disease that requires constant medical care. T1DM is the result of an irreversible destruction of pancreatic ß-cells, inevitably leading individuals to chronic exogenous insulin dependence. The prevalence of depression among T1DM is common and affects both the progression and management of the disease. The aim of this study is to present the depressive symptoms in people with T1DM who apply and those who do not apply the insulin pump therapy method and to highlight differences in terms of gender and age. The literature review was conducted using the databases PubMed, Science-Direct and Scopus. The inclusion criteria were the following: the studies had to be conducted in T1DM patients, study depressive symptomatology, the number of participants in the studies to be more than 70 people and to be in English. Initially, 464 articles were retrieved and 11 articles met the requirements for inclusion in the systematic review. The results of the systematic review, excluding paediatric patients with T1DM, showed that patients who apply the insulin pump therapy method were more likely to have higher prevalence and intensity of depressive symptoms, compared to users of multiple daily injections. Respectively, increased depressive symptoms in women with T1DM were presented, regardless of the method of treatment. Factors that mediate this difference in depressive symptoms are the sense of freedom and flexibility in lifestyle, fewer dietary restrictions, the sense of constant "bonding" and social stigma. Finally, mental health professionals should frequently evaluate the depressive symptoms of the T1DM patients, as it has a direct impact on the development and management of the disease.

Assessing depressive symptoms and diabetes distress in Type 1 diabetic adults: A comparison of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) users.

This cross-sectional observational study assesses differences in depressive symptoms and diabetes-distress between adults with type 1 diabetes using continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) insulin delivery methods. Two-hundred and seventy-one adults with type 1 diabetes were recruited who used CSII (n = 104) or MDI (n = 167). Results show that, compared to CSII users, scores on the Severity Measure for Depression - Adult questionnaire and Management and Physician subscales on the Type 1 Diabetes Distress Scale were significantly greater in users of MDI. Thus, MDI users may require greater targetted support to improve these aspects of psychological wellbeing.

Maternal-fetal outcomes of pregnant women with type 1 diabetes treated with continuous subcutaneous insulin infusion or multiple daily injections during pregnancy - A Brazilian health care referral center cohort study

ABSTRACT Objective: Pregnant women with type 1 diabetes (T1D) have an increased risk of maternal-fetal complications. Regarding treatment, continuous subcutaneous insulin infusion (CSII) has advantages compared to multiple daily injections (MDI), but data about the best option during pregnancy are limited. This study's aim was to compare maternal-fetal outcomes among T1D patients treated with CSII or MDI during pregnancy. Subjects and methods: This study evaluated 174 pregnancies of T1D patients. Variables of interest were compared between the groups (CSII versus MDI), and logistic regression analysis was performed (p < 0.05). Results: Of the 174 included pregnancies, CSII was used in 21.3% (37) and MDI were used in 78.7% (137). HbA1c values improved throughout gestation in both groups, with no difference in the first and third trimesters. The frequency of cesarean section was significantly higher in the CSII group [94.1 vs. 75.4%, p = 0.017], but there was no significant difference in the frequency of other complications, such as miscarriage, premature delivery and preeclampsia. The mean birth weight and occurrence of neonatal complications were also similar, except for the proportion of congenital malformations, which was significantly lower in the CSII group [2.9 vs. 15.6%, p = 0.048]. In regression analysis, the association of CSII with cesarean section and malformations lost significance after adjusting for HbA1c and other covariates of interest. Conclusion: In this study, we observed a higher frequency of cesarean section and a lower occurrence of congenital malformations in the CSII group, but the adjusted results might indicate that these associations are influenced by glycemic control.

Cost-effectiveness analysis of continuous subcutaneous insulin infusion versus multiple daily insulin for treatment of children with type 1 diabetes.

OBJECTIVE: To evaluate the health economics of using continuous subcutaneous insulin infusion (CSII) therapy versus multiple daily injections (MDI) therapy in children and adolescent patients with type 1 diabetes (T1D) in Qingdao, China. METHODS: A long-term cost-effectiveness analysis was conducted using the IQVIA Core Diabetes Model (CDM). The baseline characteristics of the simulated cohorts were obtained from 213 pediatric T1D patients who received care with CSII(104 cases) or MDI(109 cases) in Qingdao from 1 January 2015 to 31 March 2019. In the essential case, the expenditure of the complications and treatment of the disease with both therapies were evaluated in Chinese currency from the perspective of healthcare system. In a secondary analysis, the model used a 70-year time horizon, and a discount rate of 5% was applied to all future health outcomes and costs. A one-way sensitivity analysis was conducted on delta HbA1c, different prices of insulin pump, price of each upgrade cycle rates and different discount rates. Uncertainty was also evaluated by the probability sensitivity analysis and scenario analysis. RESULTS: In the base-case analysis, the lifetime total costs were lower for CSII group at ¥630,871 per patient compared with ¥672,672 for MDI group. The quality-adjusted life years (QALYs) gained were 11.612 and 11.197 for patients treated with CSII group and MDI group, respectively. The CSII group was cost-saving compared to MDI group. The feasibility of CSII group being cost-effective was 100% under the threshold of 3 times per capita GDP of China in 2019 (¥212,676) which was indicated from the probabilistic sensitivity analysis. Regarding scenario analysis, the ICER of the CSII group compared to MDI was between -151,583 and 153,366 RMB/QALYs, which is cost-effective. CONCLUSIONS: This economic evaluation compared CSII therapy versus MDI therapy for T1D children and adolescent patients in China and findings indicate that CSII should be considered a preferred treatment modality to MDI.