Continuous Subcutaneous Insulin Infusion Therapy Research Articles

Continuous subcutaneous insulin infusion versus multiple daily injection therapy in pregnant women with type 1 diabetes.

The study aimed to compare glycemic control and pregnancy outcomes in women with type 1 diabetes mellitus (T1DM) using multiple daily injection therapy (MDI) and continuous subcutaneous insulin infusion (CSII) and to compare outcomes of women treated with long-acting insulin or neutral protamine Hagedorn (NPH). This multicenter prospective cohort study involved women with pregestational T1DM treated with MDI and CSII. Primary outcome was glycated hemoglobin (HbA1c) before and during pregnancy. Secondary outcomes included maternal and neonatal outcomes and quality of life. Of the 121 studied women, the average age was 28.48 years, and the average body mass index was 21.29 kg/m2 at conception and 26.32 kg/m2 at delivery. Of the studied women, 78.51% had planned pregnancy. Women treated with MDI and CSII had comparable HbA1c before pregnancy or in the first and second trimesters. In the third trimester, women on CSII therapy had significantly lower HbA1c (6.07 ± 0.62 vs 6.20 ± 0.88%, p = .017), higher HbA1c on-target rate (71.43% vs 64.62%, p = .030), and greater decline of HbA1c from preconception to the third trimester (-0.65 vs -0.30%, p = .047). Fewer daily insulin requirements were observed in those used CSII compared with MDI-treated women (0.60 ± 0.22 vs 0.73 ± 0.25 U/kg/day, p = .004). Newborns born of mothers treated with the CSII method were more likely to have neonatal jaundice (adjusted odds ratio [OR] 2.76, 95% confidence interval [CI] 1.16-6.57) and neonatal intensive care unit (adjusted OR 3.73, 95%CI 1.24-11.16), and women on CSII had lower scores in patient-reported quality of life (p = .045). In the MDI group, those receiving long-acting insulin had nonsignificant lower HbA1c and higher HbA1c on-target rate in the second and third trimesters, compared with those treated with NPH. Insulin pump users may achieve better glycemic control than multiple daily insulin injections, which did not substantially improve pregnancy outcome.

Development of a Real-time Force-based Algorithm for Infusion Failure Detection.

Continuous subcutaneous insulin infusion (CSII) is a common treatment option for people with diabetes (PWD), but insulin infusion failures pose a significant challenge, leading to hyperglycemia, diabetes burnout, and increased hospitalizations. Current CSII pumps' occlusion alarm systems are limited in detecting infusion failures; therefore, a more effective detection method is needed. We conducted five preclinical animal studies to collect data on infusion failures, utilizing both insulin and non-insulin boluses. Data were captured using in-line pressure and flow rate sensors, with additional force data from CSII pumps' onboard sensors in one study. A novel classifier model was developed using this dataset, aimed at detecting different types of infusion failures through direct utilization of force sensor data. Performance was compared against various occlusion alarm thresholds from commercially available CSII pumps. The testing dataset included 251 boluses. The Bagging classifier model showed the highest performance metrics among the models tested, exhibiting high accuracy (96%), sensitivity (94%), and specificity (98%), with lower false-positive and false-negative rate compared with traditional occlusion alarm pressure thresholds. Our study developed a novel non-threshold classifier that outperforms current occlusion alarm systems in CSII pumps in detecting infusion failures. This advancement has the potential to reduce the risk of hyperglycemia and hospitalizations due to undetected infusion failures, offering a more reliable and effective CSII therapy for PWD. Further studies involving human participants are recommended to validate these findings and assess the classifier's performance in a real-world setting.

Comparison of the Sensor-Augmented Pump System with the Advanced Hybrid Closed-Loop Delivery System: Quality of Life, Diabetes Distress, and Glycaemic Outcomes in a Real-Life Context.

Type 1 diabetes mellitus (T1D) is a chronic disease that requires exogenous insulin administration and intensive management to prevent any complications. Recent innovations in T1D management technologies include the Advanced Hybrid Closed-Loop delivery system (AHCL). The pioneer AHCL system provides automated basal and automated bolus corrections when needed. This study aimed to compare the Advanced Hybrid Closed-Loop (AHCL) system and the Sensor-Augmented Pump (SAP) with Predictive Low Glucose Management (PLGM) system, in relation to glycaemic outcomes, general and diabetes-related Quality of Life (QoL), and diabetes distress. General and diabetes-related QoL were assessed with the Diabetes Quality of Life Brief Clinical Inventory (DQOL-BCI) and the World Health Organization Quality of Life-BREF (WHOQOL-BREF), respectively. Diabetes distress was assessed with the Diabetes Distress Scale for Type 1 diabetes (T1-DDS). Eighty-nine T1D adults participated in the study, mostly females (65.2%), with a mean age of 39.8 (± 11.5 years). They had on average 23 years of diabetes (± 10.7) and they were on continuous subcutaneous insulin infusion therapy. Significant differences favoring the AHCL over the SAP + PLGM system were demonstrated by lower mean glucose levels, less time above range, lower scores on DQOL-BCI, T1-DDS, and higher scores on WHOQOL-BREF. Finally, the linear regression models revealed the association of time in range in most of the above aspects. This study highlighted the advantages of the AHCL system over the SAP + PLGM system in the real-world setting in relation to general and diabetes-related QoL, diabetes distress, and glycaemic outcomes.

Expected Basal Insulin Requirement during CSII therapy by Age Group, Sex and BMI, based on 25,718 Young People with Type 1 Diabetes in the DPV Registry.

Background Since the introduction of insulin pumps into the therapy of paediatric subjects, different approaches have been taken to find optimal basal rates. Previously, the DPV registry provided circadian basal rate patterns for different age groups. As the number of pump users has increased recently and short-acting insulin analogues are now predominant, we performed a new analysis with a larger data pool. Methods We included all recent basal profiles from T1D patients between 1 and 25 years from the DPV 2021 data pool. We excluded night-time-only pump users, human regular insulin users, and daily basal rates < 0.05 U/kgBW/d and >1.0 U/kgBW/d. Results In the analysis of profiles from 25,718 young persons with T1D, differences in the daily pattern of basal rates were found between age groups. In addition, we saw significant (p<0.001) differences in total daily basal dose between genders in all age groups except adults. In addition, the shape of the expected basal-rate pattern differed by BMI, HbA1c and use of continuous glucose monitoring. Discussion This analysis demonstrates multiple factors influencing basal patterns and insulin requirement, including age group, gender, overweight, HbA1c, bolus frequency and sensor use. As circadian basal rates are still mandatory for initiating insulin pump therapy with or without automation, a multimodal approach is necessary to estimate optimal basal rates.

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

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. 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. 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. 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.

Hand grip strength is inversely associated with total daily insulin dose requirement in patients with type 2 diabetes mellitus: a cross-sectional study.

Short-term (2 weeks to 3 months) insulin intensive therapy using continuous subcutaneous insulin infusion (CSII) can improve islet beta cell function and prolong glycemic remission in patients with newly diagnosed type 2 diabetes mellitus (T2DM). However, the total daily insulin dose (TDD, IU/kg/d) required to achieve near-normoglycemic control with CSII still needs to be frequently adjusted based on blood glucose monitoring. Although real-time continuous glucose monitoring (rtCGM), which measures the interstitial fluid glucose concentration continuously without much difficulty, facilitates the adjustment of insulin dosage, its adoption in the T2DM population is strictly limited by insurance coverage and lack of awareness of rtCGM among clinicians. Thus, it is of clinical significance to identify easy-to-use parameters that may allow a more rapid and accurate prediction of TDD requirement. This study aimed to explore the association between hand grip strength (HGS) and TDD requirement in patients with T2DM receiving CSII therapy. A total of 180 eligible patients with T2DM were enrolled in the study and divided into three groups based on their HGS: low (L), medium (M), and high (H). The TDD requirement was calculated on day 7 or 8 of CSII treatment. Anthropometric parameters, including HGS, skeletal muscle mass, skeletal muscle index (SMI) and 6-m gait speed, and laboratory data, were collected on the morning of the second day after admission, within the first 24 h of CSII therapy. These parameters were used to identify significant predictors of TDD requirement using Pearson or Spearman correlation test, and stepwise multiple regression analysis. There were no significant differences in age, duration of T2DM, waist-to-hip ratio (WHR), body mass index (BMI), blood pressure, liver function, estimated glomerular filtration rate, triglyceride, total cholesterol, glycosylated hemoglobin A1c (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), and homeostasis model assessment of beta cell function (HOMA-β) among the groups. The H group had higher body muscle mass-to-fat ratio (BMFR), skeletal muscle mass-to-fat ratio (SMFR), SMI, 6-m gait speed, and lower TDD requirement than the M and L groups. The HGS negatively correlated with TDD requirement (r = -0.33, p < 0.001) after adjusting for sex, age, BMI, WHR, HbA1c, Ln (HOMA-β), Ln (HOMA-IR), Ln (BMFR), Ln (SMFR), SMI, and 6-m gait speed. Multivariate stepwise regression analysis indicated that HGS was an independent predictor of TDD requirement in patients with T2DM (β = -0.45, p < 0 001). Lower HGS is associated with an increased TDD requirement in T2DM patients. HGS may facilitate the prediction of TDD requirement in T2DM patients receiving CSII therapy.

927-P: Robustness of MiniMed Advanced Hybrid Closed-Loop (AHCL) Algorithm on a Spectrum of Glycemic Control

Objective: To evaluate effectiveness of MiniMed™ AHCL on outcomes of study participants with different glycemic management challenges. Methods: Adults (N=128, ≥18 years) with T1D from 16 investigational sites, underwent baseline run-in (~2wks) of continuous subcutaneous insulin infusion (CSII), sensor-augmented pump (SAP) or HCL therapy, followed by study period (3 months) with MiniMed™ AHCL. In this exploratory analysis, participants with different baseline glycemic characteristics (mean SG and SD of SG) were identified using Hierarchical Clustering Analysis with Ward’s method and stratified into 5 cohorts. AHCL glycemic outcomes were evaluated and compared to run-in outcomes. Results: After AHCL initiation, overall glycemic control improved regardless of baseline glycemic characteristics (i.e., low-to-high mean SG and SD of SG) (Table). As expected, those from Cluster 5 with highest baseline mean SG and SD of SG improved the most. While those from Cluster 1 with lowest baseline mean SG and SD of SG achieved the highest TIR. Although those from Cluster 2 achieved better glycemic outcomes compared to their baseline, they didn’t outperform those from Cluster 3, possibly due to their higher SD of SG and less aggressive carb ratio. Conclusion: Improved glycemic control was observed with MiniMed™ AHCL regardless of glycemic conditions at baseline. Disclosure J.Shin: Employee; Medtronic. Z.Dai: Employee; Medtronic. F.Niu: None.

104-LB: Interim Analysis of a Prospective Study Investigating User Satisfaction and Metabolic Outcome of People with T1D Using an Innovative Modular Micropump System

Aims: People with type 1 diabetes (T1D) can administer insulin by multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Despite proven clinical benefits, the uptake of CSII is still low. Thus, this study investigates the change in treatment satisfaction and metabolic outcome of people with T1D switching from MDI to CSII therapy using an innovative modular micropump system. Methods: A total of 50 CSII-naive adults with T1D from Argentina were enrolled in a multi-center, prospective, single-armed study for the Accu-Chek® Solo micropump system (ACS). Change in diabetes treatment satisfaction after 13 weeks (mean 108, min 83, max 176 days) was assessed by the “Impact and Satisfaction” section of the Diabetes Technology Questionnaire (DTQ) as primary outcome. In addition, changes in the DTQ after 1 year and the HbA1c after 13 weeks and 1 year were measured. Results: The change score of the “Impact and satisfaction” part of the DTQ was 113.37 ± 16.74 (mean ± SD, p &amp;lt; 0.0001) after 13 weeks and 111.42 ± 14.42 (p &amp;lt; 0.0001) after 1 year (with 90 as non-change score). Based on predefined sub-categories, the following mean DTQ change scores were measured after 13 weeks / 1 year: 3.81 ± 0.61 / 3.79 ± 0.52 for “diabetes distress and burden”, 3.96 ± 0.68 / 3.98 ± 0.60 for “hypoglycemia fear, worry and behavior”, 3.56 ± 0.71 / 3.53 ± 0.52 for “device acceptance and satisfaction” (1 = much worse, 5 = much better). The mean HbA1c decreased from 8.20 % ± 1.34 to 7.92 % ± 1.18 (-0.28 %pt, p = 0.0341) after 13 weeks and 7.87 % ± 1.26 (-0.37 %pt, p = 0.0467) after 1 year. Thereby, one event of severe hypoglycemia and diabetic ketoacidosis (DKA) was reported during 17520 device days. Conclusion: The switch from MDI to CSII using the ACS led to a significant improvement of subjects’ treatment satisfaction and HbA1c. Effects were already measurable after 13 weeks and continued through 1 year indicating that using the ACS reduces disease burden among people with T1D. Disclosure A. Dain: None. S. Moceri: Employee; Roche Diabetes Care. N. Dagenbach: Employee; Roche Diabetes Care. C. Rees: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. G. Vogt: Employee; Roche Diabetes Care. T. J. Etter: None.

Assessing attitudes towards insulin pump therapy in adults with type 1 diabetes: Italian validation of the Insulin Pump Attitudes Questionnaire (IT-IPA questionnaire)

AimsThe aim of the study was to adapt the German version of the insulin pump therapy (IPA) questionnaire to Italian (IT-IPA) and to evaluate its psychometric properties in adults with type 1 diabetes.MethodsWe conducted a cross-sectional study, data were collected through an online survey. In addition to IT-IPA, questionnaires evaluating depression, anxiety, diabetes distress, self-efficacy, and treatment satisfaction were administered.The six factors identified in the IPA German version were assessed using confirmatory factor analysis; psychometric testing included construct validity and internal consistency.ResultsThe online survey was compiled by 182 individuals with type 1 diabetes: 45.6% continuous subcutaneous insulin infusion (CSII) users and 54.4% multiple daily insulin injection users.The six-factor model had a very good fit in our sample. The internal consistency was acceptable (Cronbach’s α = 0.75; 95% IC [0.65–0.81]).Diabetes treatment satisfaction was positively correlated with a positive attitude towards CSII therapy (Spearman’s rho = 0.31; p < 0.01), less Technology Dependency, higher Ease of Use, and less Impaired Body Image. Furthermore, less Technology Dependency was associated with lower diabetes distress and depressive symptoms.ConclusionsThe IT-IPA is a valid and reliable questionnaire evaluating attitudes towards insulin pump therapy. The questionnaire can be used for clinical practice during consultations for shared decision-making to CSII therapy.

Insulin pump therapy with and without continuous glucose monitoring in pregnant women with type 1 diabetes: a prospective observational Orchestra Foundation study in Poland

AimsThe effects of continuous subcutaneous insulin infusion (CSII) therapy with or without continuous glucose monitoring (CGM) on neonatal outcomes and glycemic outcomes of pregnant women with type 1 diabetes (T1D), living in Poland, were assessed.MethodsThis prospective observational study enrolled women with T1D (N = 481, aged 18–45 years) who were pregnant or planned pregnancy. All used CSII therapy and a subset used CGM with CSII (CSII + CGM). Neonatal outcomes (e.g., rate of large for gestational age [LGA] delivery [birth weight > 90th percentile]) and maternal glycemia (e.g., HbA1c and percentage of time at sensor glucose ranges) were evaluated.ResultsOverall HbA1c at trimesters 1, 2, and 3 was 6.8 ± 1.1% (50.9 ± 12.3 mmol/mol, N = 354), 5.8 ± 0.7% (40.1 ± 8.0 mmol/mol, N = 318), and 5.9 ± 0.7% (41.4 ± 8.0 mmol/mol, N = 255), respectively. A HbA1c target of < 6.0% (42 mmol/mol) at each trimester was achieved by 20.9% (74/354), 65.1% (207/318), and 58.0% (148/255), respectively. For women using CSII + CGM versus CSII only, HbA1c levels at trimesters 1, 2, and 3 were 6.5 ± 0.9% versus 7.1 ± 1.3% (47.8 ± 9.7 mmol/mol versus 54.3 ± 14.0 mmol/mol, p < 0.0001), 5.7 ± 0.6% versus 6.0 ± 0.9% (38.9 ± 6.5 mmol/mol versus 41.6 ± 9.3 mmol/mol, p = 0.0122), and 5.8 ± 0.6% versus 6.1 ± 0.8% (40.3 ± 6.9 mmol/mol versus 42.9 ± 9.1 mmol/mol, p = 0.0117), respectively. For the overall, CSII only, and CSII + CGM groups, rates of LGA delivery were 22.7% (74/326), 24.6% (34/138), and 21.3% (40/188), respectively.ConclusionsObservational assessment of women with T1D using CSII therapy demonstrated low HbA1c throughout pregnancy and low rates of LGA. The addition of CGM to CSII therapy compared to CSII therapy alone was associated with some improved maternal glycemic and neonatal outcomes.Clinicaltrials.gov identifierNCT01779141 (January 2013).

Insulin pump complications among children with diabetes

Several children with diabetes in our clinic use continuous subcutaneous insulin infusion therapy. Recently a 5-year-old presented with a dysfunctional pump, and it took 2 days to identify the problem and resolve it. What are the potential pitfalls of insulin pumps in children and how can these be prevented? The use of continuous subcutaneous insulin infusion pumps has increased considerably during the past decade. Adverse events can range from mild events that can be resolved by troubleshooting at home, to severe incidents that necessitate admission to the hospital. Adverse events include technical issues, skin complications that can lead to infection, and metabolic imbalances that can lead to hospitalization. Long-term monitoring and targeted education are needed for children and their families to ensure early identification of problems with the pump and to avoid diabetic ketoacidosis or hypoglycemia.

Risk Factors for Glycemic Control in Hospitalized Patients with Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy.

Patients with diabetes are confronted with numerous obstacles to achieve adequate glycemic control during hospitalization. The aim of this study was to explore the risk factors associated with glycemic control in hospitalized patients with type 2 diabetes mellitus (T2DM) treated with continuous subcutaneous insulin infusion (CSII). This cross-sectional study included 5223 patients hospitalized with T2DM in a tertiary hospital in Xiamen (China) between January 2017 and December 2019. All patients were managed according to established protocols for glycemic monitoring and insulin pump treatment regimens. Demographic information and clinical profiles were collected from electronic health records. Multiple linear regression analysis was used to identify the risk factors associated with glycemic control. Among the 5223 hospitalized patients with T2DM receiving CSII therapy, 55.2% achieved their ideal blood glucose level (3.9-10.0mmol/L), 44.5% experienced hyperglycemia (> 10.0mmol/L), and 0.3% experienced hypoglycemia (< 3.9mmol/L) during their hospitalization. Multivariate analyses showed that among inpatients with T2DM, older age, male gender, higher low-density lipoprotein-cholesterol (LDL-C) level, lower C-peptide (C-P) level, lower body mass index (BMI), longer duration of diabetes, previous insulin prescriptions, nephropathy, and retinopathy were factors more likely to be associated with a blood glucose level in the hyperglycemic range (P < 0.05). We also observed that among hospitalized patients with T2DM, those with lower BMI, lower C-P, lower LDL-C, longer disease duration, and previous insulin prescriptions were more likely to correlate with a higher proportion of hypoglycemia range (all P < 0.05). Older age, male gender, lower BMI, lower C-P, higher LDL-C, previous insulin prescriptions, longer duration of diabetes, nephropathy, and retinopathy may be risk factors for a higher proportion of hyperglycemic events in hospitalized patients with T2DM under CSII therapy. Furthermore, lower BMI, lower C-P, lower LDL-C, longer duration of diabetes, and previous insulin prescriptions were found to be important factors for a higher proportion of hypoglycemic events. Evaluating the clinical features, comorbidities, and complications of hospitalized patients is essential to achieve reasonable glycemic control.

Monitoring of continuous subcutaneous insulin infusion treatment in Portugal and its implications for diabetes management.

Intensive insulin therapy in the treatment of type 1 diabetes can, in place of multiple daily injections of subcutaneous insulin (MDI), be performed with continuous subcutaneous insulin infusion (CSII) systems. This method allows for better glycemic control and thus reduces the risk of complications of the disease. The aim of this study was to evaluate the results of treatment with CSII in Portugal. A retrospective analysis of the records on the national CSII platform was carried out between January 2010 and August 2021. All the registered patients are followed in certified CSII treatment centers in Portugal. Of the 7135 registered patients, 3807 were excluded due to absence of monitoring data. The reasons for treatment were analyzed and a comparison was made between patients with and without CSII. The statistical significance considered was α < 0.05. A total of 3328 patients were included in the study, 1136 under MDI and 2192 under CSII. The main reasons for CSII use were marked glycemic variability (25%) and HbA1c greater than 7% (23%). Patients under CSII had a lower HbA1c (7.7 ± 1.0% vs. 8.0 ± 1.5%, p < 0.001), as well as a lower frequency of episodes of severe hypoglycemia (1.4 vs. 3.3 per 100 patient-years, p < 0.001), and ketoacidosis (1 vs. 2.4 per 100 patient-years, p < 0.001). The present analysis validates the advantage of using CSII in metabolic control and reduction of acute complications of type 1 diabetes, both severe hypoglycemia and ketoacidosis, in the Portuguese population. CSII therapy is classically associated with an increased risk of ketoacidosis; however, in experienced centers and adequate patient education, the opposite is found.

Continuous Subcutaneous Insulin Infusion in Type 1 Diabetes Mellitus Patients: Results from the Spanish National Registry.

Aim: To analyze the clinical effect of continuous subcutaneous insulin infusion (CSII) in type 1 diabetes mellitus (T1D) patients in the Spanish real-world scenario. Methods: All T1D patients on CSII registered in the SPAnish Insulin Pump (SPAIP) registry were included. The primary efficacy outcome was change in HbA1c during follow-up. Secondary efficacy outcomes included: insulin pump indications, diabetes complication rates, insulin and pump use, and continuous glucose monitoring (CGM) glycometrics. Patient data were typed through the web-based SPAIP registry. Results: Data from 2979 T1D patients treated with CSII were analyzed. The median age was 44 years (interquartile range [IQR] 34-52 years), and T1D duration was 27 years (IQR 18-35 years). The median duration of CSII therapy was 6 years (IQR 3-10 years). The main indications for treatment were suboptimal glycemic control (33.8%), hypoglycemia (22.1%), and increased glycemic variability (18.8%). Glycated hemoglobin decreased by 6 mmol/mol (95% CI, -5 to -6 mmol/mol, P < 0.001) [-0.5%, 95% CI, -0.4 to -0.5, P < 0.001] during the follow-up. The percentage of patients with severe hypoglycemia decreased from 14.9% to 0.9% (P < 0.001). We observed an inverse correlation between final HbA1c levels and CGM adherence (R = -0.24, P < 0.001) or percentage of time with active hybrid closed-loop functions (R = -0.25, P < 0.001). Conclusions: CSII treatment was associated with a sustained improvement in glycemic control in the Spanish population. This benefit was greater among patients with higher CGM or active hybrid closed-loop functions adherence. The protocol was publicly registered at ClinicalTrials.gov (NCT04761094).

Comparing the effectiveness of continuous subcutaneous insulin infusion with multiple daily insulin injection for patients with type 1 diabetes mellitus evaluated by retrospective continuous glucose monitoring: A real-world data analysis.

ObjectiveRegarding the effects and practical application of insulin pumps on patients with type 1 diabetes mellitus (T1DM), the real-world evidence is limited especially concerning the incidence of hypoglycemia. This study aimed to compare the efficacy of continuous subcutaneous insulin infusion (CSII) therapy with multiple daily injection (MDI) therapy on glycemic metrics evaluated by retrospective continuous glucose monitoring (CGM) in Chinese patients with T1DM.MethodsIn total, 362 T1DM Chinese patients from the outpatient department of the Second Xiangya Hospital, Central South University, who underwent intensive insulin therapy and used a retrospective CGM system were included in this retrospective cross-sectional study. Comprehensive analysis of clinical and biological features and retrospective CGM derived-metrics was performed on the 362 enrolled T1DM patients who underwent CSII (n = 61) or MDI (n = 301) therapy (defined as 4 or more insulin injections per day).ResultsOur findings demonstrated that patients who underwent CSII therapy, compared with those who received MDI therapy, had lower levels of hemoglobin A1c (HbA1c) and fasting blood glucose; moreover, CSII therapy was associated with better glycemic outcomes in terms of increasing time in range (TIR), decreasing time above range (TAR), and achieving CGM-associated targets of TIR ≥70% and TAR <25%. However, patients who underwent CSII therapy did not experience decreasing time below range (TBR), achieving CGM-associated targets of TBR <4%, and reduction of the risk of hypoglycemia as evidenced by comparing TBR and low blood glucose index (LBGI) between the two treatment regimens. The parameters of glycemic variability, such as standard deviation of glucose (SD), mean amplitude glycemic excursion (MAGE), and large amplitude glycemic excursion (LAGE) in T1DM patients who underwent CSII therapy outperformed.ConclusionOur results provided further evidence that CSII therapy is safe and effective for management of Chinese T1DM patients, which was confirmed by a lower HbA1c level and better CGM-derived metrics but no demonstration of improvment in the risk of hypoglycemia. To achieve more satisfactory glycemic outcomes through the utilization of CSII therapy for Chinese T1DM patients, a strong physician-patient relationship is essential.

Continuous Subcutaneous Insulin Infusion (CSII) Combined with Oral Glucose-Lowering Drugs in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis of Randomized, Controlled Trials.

The clinical efficacy of continuous subcutaneous insulin infusion (CSII) therapy combined with six classes of oral glucose-lowering drugs (GLDs) (TZDs/metformin/acarbose/GLP-1 receptor agonist/SGLT-2 inhibitor/DPP-4 inhibitor) was evaluated by a network meta-analysis to provide an evidence-based reference in making a clinical decision on CSII combined with drugs in the treatment of type 2 diabetes. Data were retrieved from eight databases: the Chinese Journal Full-Text Database (CNKI), VIP Chinese Science and Technology Periodicals Full-Text Database (VP-CSFD), Wanfang Data Journal Paper Resource (WANFANG), China Biomedical Database (CBM), PubMed, Embase, Cochrane Library, and Web of Science. The retrieval period dated from the library’s construction to 27 June 2021. The search was for randomized, controlled trial studies (RCT) on insulin infusion (CSII) combined with oral hypoglycemic drugs (TZDs/metformin/acarbose/GLP-1 receptor agonist/SGLT-2 inhibitor/DPP-4 inhibitor) in the treatment of type 2 diabetes. Quality evaluation and data extraction were performed on the studies included, and network meta-analysis was performed with R4.0.1 software. A total of 56 publications was included in the final network meta-analysis, with a total sample size of 4395. Results based on the network meta-analysis were that CSII combined with a metformin works best on fasting blood glucose (FBG) and 2 h postprandial blood glucose (2hPG) and improves insulin resistance (lower HOMA-IR levels). CSII combined with a DPP-4 inhibitor had the best clinical effect in reducing glycosylated hemoglobin levels. Treatment with CSII combined with a DPP-4 inhibitor was the fastest way to achieve the blood glucose standard. In terms of insulin dosage, an insulin pump (CSII) combined with the GLP-1 receptor agonist can significantly reduce insulin dosage. Network meta-analysis evidence suggests that an insulin infusion (CSII) combined with oral hypoglycemic drugs can improve clinical efficacy in controlling blood sugar and improving insulin resistance, insulin dosage, and standard time. However, the most outstanding performance was that of insulin infusion (CSII) combined with metformin, which had the best clinical effect in controlling blood sugar and improving insulin resistance.

Short-time intensive insulin therapy upregulates 3 beta- and 17 beta-hydroxysteroid dehydrogenase levels in men with newly diagnosed T2DM.

ObjectiveOur previous study has found that short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes mellitus (T2DM) increased serum testosterone levels, but the underlying mechanisms remain unclear.Design and methodsIn this self-controlled study, 43 men with newly diagnosed drug naïve T2DM, aged 18-60 years, with HbA1c >9.0% were treated with continuous subcutaneous insulin infusion (CSII) to normalize blood glucose within one week. Venous blood specimens were collected for measuring of serum total testosterone, dehydroepiandrosterone sulfate (DHEA-S), 3β- and 17β-hydroxysteroid dehydrogenase (3β- and 17β-HSD) concentrations before and after insulin therapy.ResultsTestosterone increased from 13.0 (11.3, 14.6) nmol/L to 15.7 (13.9, 17.5) nmol/L after intensive insulin therapy (p<0.001), while the levels of DHEA-S decreased significantly after treatment (from 6.5 (5.7, 7.3) μmol/L to 6.0 (5.3, 6.7) μmol/L, p=0.001). The ratio of testosterone/DHEA-S increased significantly (2.4 (2.0, 2.8) vs. 3.1 (2.6, 3.7) nmol/μmol, p<0.001). After blood glucose normalization with the short-term CSII therapy, 3β-HSD increased from 11.0 (9.5, 12.5) pg/mL to 14.6 (13.5, 15.7) pg/mL, p=0.001, and 17β-HSD increased from 20.7 (16.3, 25.2) pg/mL to 28.2 (23.8, 32.5) pg/mL, p=0.009.ConclusionsBlood glucose normalization via short-term intensive insulin therapy increases plasma total testosterone levels in men with newly diagnosed type 2 diabetes, associated with a decreased level of DHEA-S, probably because of the enhanced conversion from DHEA to testosterone catalyzed by 3β-HSD and 17β-HSD.

A simulator with realistic and challenging scenarios for virtual T1D patients undergoing CSII and MDI therapy

In silico simulations have become essential for the development of diabetes treatments. However, currently available simulators are not challenging enough and often suffer from limitations in insulin and meal absorption variability, which is unable to realistically reflect the dynamics of people with type 1 diabetes (T1D). Additionally, T1D simulators are mainly designed for the testing of continuous subcutaneous insulin infusion (CSII) therapies. In this work, a simulator is presented that includes a generated virtual patient (VP) cohort and both fast- and long-acting Glargine-100 U/ml (Gla-100), Glargine-300 U/ml (Gla-300), and Degludec-100 U/ml (Deg-100) insulin models. Therefore, in addition to CSII therapies, multiple daily injections (MDI) therapies can also be tested. The Hovorka model and its published parameter probability distributions were used to generate cohorts of VPs that represent a T1D population. Valid patients are filtered through restrictions that guarantee that they are physiologically acceptable. To obtain more realistic scenarios, basal insulin profile patterns from the literature have been used to identify variability in insulin sensitivity. A library of mixed meals identified from real data has also been included. This work presents and validates a methodology for the creation of realistic VP cohorts that include physiological variability and a simulator that includes challenging and realistic scenarios for in silico testing. A cohort of 47 VPs has been generated and in silico simulations of both CSII and MDI therapies were performed in open-loop. The simulation outcome metrics were contrasted with literature results.

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

ABSTRACT 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.

95-LB: Interim Data from a Prospective Study Measuring User Satisfaction and Metabolic Outcome while Using a Novel Modular Patch Pump System

Background and aims: Intensified insulin therapy for type 1 diabetes (T1D) can be administered by multiple daily injection therapy (MDI) or continuous subcutaneous insulin infusion therapy (CSII) . Despite the clinical benefits of CSII, its therapeutic implementation rate remains low. Thus, this study aims to evaluate the change in treatment satisfaction and metabolic changes of people with T1D switching from MDI to CSII therapy using a novel modular patch pump system. Materials and Methods: A total of 50 adults from Argentina with T1D, naïve to CSII, were enrolled in a multi - center, prospective, single - armed study for the Accu-Chek® Solo micropump system (ACS) . Change in diabetes treatment satisfaction after 13 weeks (mean 106, min 83, max 176 days) was assessed by the “Impact and Satisfaction” section of the Diabetes Technology Questionnaire (DTQ) as the primary outcome. In addition, changes in the HbA1c were reported by the investigator as a secondary outcome. Results: The mean DTQ “now” score improved from 92.96 ± 14.98 to 103.15 ± 19.47 (p = 0.0166) and the “change” score, as the primary outcome, was 113.24 ± 17.50 (p &amp;lt; 0.0001) . Based on pre - defined sub - categories, the following mean DTQ scores were measured: 3.83 ± 0.62 for “diabetes distress and burden,” 3.98 ± 0.70 for “hypoglycemia fear, worry and behavior,” 3.59 ± 0.70 for “device acceptance and satisfaction,” 3.92 ± 0.61 for “other.” In addition, the mean HbA1c, as a secondary outcome, decreased from 8.19 % ± 1.36 to 7.83 % ± 1.23 (- 0.37 %pt, p = 0.0148) . Thereby, the HbA1c reduction was not associated with any reported incidents of hypoglycemia. Conclusion: The switch from MDI to the Accu-Chek® Solo micropump system led to a significant improvement of subjects’ treatment satisfaction after 13 weeks, which was linked to a significant reduction of the outcome HbA1c without any reported incidents of hypoglycemia. Disclosure A. Dain: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diabetes Care, Speaker’s Bureau; Abbott Diabetes, AstraZeneca, Lilly Diabetes, Novo Nordisk. S. Moceri: Employee; Roche Diabetes Care. N. Dagenbach: Employee; Roche Diabetes Care. C. Rees: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. G. Vogt: Employee; Roche Diabetes Care. T. J. Etter: Employee; Roche Diabetes Care. Funding Roche Diabetes Care Gmbh, Mannheim, Germany