Use Of Continuous Subcutaneous Insulin Infusion Research Articles

Multiple basal infusion rates in open-loop insulin delivery systems: is there a metabolic benefit?

To evaluate glycemic control according to the number of daily basal rates (BRs) in type 1 diabetes patients using continuous subcutaneous insulin infusion (CSII). Cross-sectional study of patients treated with an open-loop CSII for at least 6 months and using a flash glucose monitoring system. Patients were divided into 2 groups: group 1 (G1) and group 2 (G2), with ≤4 and >4 BRs/24h, respectively. The groups were compared regarding HbA1c, time in range (TIR), time above range (TAR), time below range (TBR), glucose management indicator (GMI), glucose variability and data related to hypoglycemia. Regression models were performed. The study included 99 patients (n = 55 in G1; n = 44 in G2). Median (Interquartile range) overall age was 30 (17) years, with 19.5 (48) and 51 (77) months of CSII use, respectively. The median number of different BRs was 3 (2) for G1 and 6 (2) for G2. There were no differences concerning age, sex, educational stage, weight, and insulin analog used. G2 had longer disease duration, longer CSII use, and higher total basal daily dose/kg. No significant differences regarding HbA1c, median glucose, GMI, TIR, TAR, and CV were found. G2 patients had more hypoglycemia, more asymptomatic hypoglycemia, and higher TBR. After adjusting for potential confounders, G1 maintained a lower risk of asymptomatic hypoglycemia. Programming open-loop CSII devices with more than 4 BRs does not improve metabolic control. Additionally, it seems to be a risk factor for hypoglycemia and was an independent predictor for asymptomatic hypoglycemia.

Does insulin pump therapy offer benefits for behaviour, mood, cognition and HbA1c in children and adolescents with type 1 diabetes? A randomised controlled trial with observational follow-up

AimsImproved behaviour, mood, cognition and HbA1c have been reported with short-term use of continuous subcutaneous insulin infusion (CSII) in youth with type 1 diabetes (T1D). We sought to re-examine these...

Psychosocial and Glycemic Benefits for Insulin-Using Adults With Type 2 Diabetes After Six Months of Pump Therapy: A Quasi-Experimental Approach.

Continuous subcutaneous insulin infusion (CSII) use in adults with type 1 diabetes offers psychosocial and clinical benefits, but little is known about its impact on such outcomes in the type 2 diabetes (T2D) population. To address this gap, we conducted a quasi-experimental prospective study to assess psychosocial, glycemic, and behavioral changes over six months in T2D adults on multiple daily injections (MDI) who were interested in starting Omnipod DASH, comparing those who did versus did not start on it. In total, 458 adults with T2D completed baseline questionnaires assessing psychosocial dimensions (eg, diabetes distress), clinical metrics (eg, HbA1c [glycosylated hemoglobin]), and behavioral measures (eg, missed mealtime boluses). Six months later, 220 (48.0%) completed the same questionnaire again. To examine differences in outcomes over time between those who began CSII (n = 176) versus those who remained on MDI (n = 44), a latent change score approach was used. The CSII users reported greater gains than MDI users on all major psychosocial metrics, including overall well-being (P < .001) diabetes distress (P < .001), perceived T2D impact on quality of life (P = .003), and hypoglycemic worries and concerns (P < .001). The CSII users similarly reported a larger decline in HbA1c than MDI users (P < .05) and greater declines in two critical self-care behaviors: number of missed mealtime boluses (P < .001) and number of days of perceived overeating (P = .001). The introduction of CSII (Omnipod DASH) in T2D adults can contribute to significant psychosocial, glycemic, and behavioral benefits, indicating that broader use of CSII in the T2D population may be of value.

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.

Racial Disparities in Diabetes Technology Adoption and Their Association with HbA1c and Diabetic Ketoacidosis.

Poorer glycemic control and higher diabetic ketoacidosis (DKA) rates are seen in racial/ethnic minorities with type 1 diabetes (T1D). Use of diabetes technologies such as continuous glucose monitors (CGM), continuous subcutaneous insulin infusion (CSII) and automated insulin delivery (AID) systems has been shown to improve glycemic control and reduce DKA risk. We examined race/ethnicity differences in diabetes technology use and their relationship with HbA1c and DKA. Data from patients aged ≥12 years with T1D for ≥1 year, receiving care from a single diabetes center, were examined. Patients were classified as Non-Hispanic White (n=3945), Non-Hispanic Black (Black, n=161), Hispanic (n=719), and Multiracial/Other (n=714). General linear models and logistic regression were used. Black (OR=0.22, 0.15-0.32) and Hispanic (OR=0.37, 0.30-0.45) patients were less likely to use diabetes technology. This disparity was greater in the pediatric population (p-interaction=0.06). Technology use associated with lower HbA1c in each race/ethnic group. Among technology users, AID use associated with lower HbA1c compared to CGM and/or CSII (HbA1c of 8.4% vs 9.2%, respectively), with the greatest difference observed for Black adult AID users. CSII use associated with a lower odds of DKA in the past year (OR=0.73, 0.54-0.99), a relationship that did not vary by race (p-interaction =0.69); this inverse association with DKA was not observed for CGM or AID. Disparities in diabetes technology use, DKA, and glycemic control were apparent among Black and Hispanic patients with T1D. Differences in technology use ameliorated but did not fully account for disparities in HbA1c or DKA.

Area deprivation and demographic factors associated with diabetes technology use in adults with type 1 diabetes in Germany.

Diabetes technology improves glycemic control and quality of life for many people with type 1 diabetes (T1D). However, inequalities in access to diabetes technology exist in many countries. In Germany, disparities in technology use have been described in pediatric T1D, but no data for adults are available so far. We therefore aimed to analyze whether demographic factors and area deprivation are associated with technology use in a representative population of adults with T1D. In adults with T1D from the German prospective diabetes follow-up registry (DPV), we analyzed the use of continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), and sensor augmented pump therapy (SAP, with and without automated insulin delivery) in 2019-2021 by age group, gender, migration background, and area deprivation using multiple adjusted regression models. Area deprivation, defined as a relative lack of area-based resources, was measured by quintiles of the German index of Multiple Deprivation (GIMD 2015, from Q1, least deprived, to Q5, most deprived districts). Among 13,351 adults with T1D, the use of technology decreased significantly with older age: CSII use fell from 56.1% in the 18-<25-year age group to 3.1% in the ≥80-year age group, CGM use from 75.3% to 28.2%, and SAP use from 45.1% to 1.5% (all p for trend <0.001). The use of technology was also significantly higher in women than in men (CSII: 39.2% vs. 27.6%; CGM: 61.9% vs. 58.0%; SAP: 28.7% vs. 19.6%, all p <0.001), and in individuals without migration background than in those with migration background (CSII: 38.8% vs. 27.6%; CGM: 71.1% vs. 61.4%; SAP: 30.5% vs. 21.3%, all p <0.001). Associations with area deprivation were not linear: the use of each technology decreased only from Q2 to Q4. Our real-world data provide evidence that higher age, male gender, and migration background are currently associated with lower use of diabetes technology in adults with T1D in Germany. Associations with area deprivation are more complex, probably due to correlations with other factors, like the higher proportion of migrants in less deprived areas or the federal structure of the German health care system.

911-P: Changes in Metrics of Continuous Glucose Monitoring during COVID-19 in Children and Adolescents with Type 1 Diabetes

Background: Data on the changes in glucose control in pediatric patients with type 1 diabetes (T1D) affected by COVID-19 is lacking. We aimed to evaluate changes in metrics of continuous glucose monitoring (CGM) system during COVID-19 infection in children and adolescents with T1D. Methods: We included 21 children and adolescents with T1D, aged younger than 20 years, with at least 70% of CGM readings during COVID-19. Symptoms of COVID-19 infection were investigated through a questionnaire. The effects of COVID-19 on metrics of CGM were assessed at five different time points [2 weeks before-COVID-19 (Time 1), 1 week before-COVID-19 (Time 2), 1 week during COVID-19 (Time 3), 1 week after COVID-19 (Time 4), and 2 weeks after COVID-19 (Time 5)]. Results: Of 21 patients (6 males and 15 females), mean age was 11.4 ± 4.7 years, and mean disease duration was 5.1 ± 4.8 years. All had at least one related symptoms (mean duration of symptoms of 5.2 ± 3.7 days); no one required hospitalization. Glucose management indicator (GMI) and the percentage of time spent above range (&amp;gt; 250 mg/dL) were significantly higher at Time 3 compared to Time 5 (7.8 ± 1.4 % vs 7.2 ± 1.4 %; P = 0.001 and 18.3 ± 18.5 % vs 13.0 ± 15.7 %; P = 0.016, respectively). According to the insulin delivery methods, GMI at Time 2 was significantly higher compared to Time 5 in patients treated with multiple daily injection (MDI) (n = 13) but not in those using continuous subcutaneous insulin infusion (CSII) (n = 6). Conclusion: Pediatric patients with T1D experience mild COVID-19 infection with worsening glycemic control during COVID-19. The use of CSII is more effective in maintaining stable glycemic control during COVID-19 infection compared to MDI therapy. Disclosure H.Kim: None. S.Shin: None. S.Kim: None. J.Kim: None.

Type 1 diabetes management: Room for improvement.

Optimal diabetes care and risk factor management are important to delay micro- and macrovascular complications in individuals with type 1 diabetes (T1D). Ongoing improvement of management strategies requires the evaluation of target achievement and identification of risk factors in individuals who do (or do not) achieve these targets. Cross-sectional data were collected from adults with T1D visiting six diabetes centers in the Netherlands in 2018. Targets were defined as glycated hemoglobin (HbA1c) <53 mmol/mol, low-density lipoprotein-cholesterol (LDL-c) <2.6 mmoL/L (no cardiovascular disease [CVD] present) or <1.8 mmoL/L (CVD present), or blood pressure (BP) <140/90 mm Hg. Target achievement was compared for individuals with and without CVD. Data from 1737 individuals were included. Mean HbA1c was 63 mmol/mol (7.9%), LDL-c was 2.67 mmoL/L, and BP 131/76 mm Hg. In individuals with CVD, 24%, 33%, and 46% achieved HbA1c, LDL-c, and BP targets respectively. In individuals without CVD these percentages were 29%, 54%, and 77%, respectively. Individuals with CVD did not have any significant risk factors for HbA1c, LDL-c, and BP target achievement. In comparison, individuals without CVD were more likely to achieve glycemic targets if they were men and insulin pump users. Smoking, microvascular complications, and the prescription of lipid-lowering and antihypertensive medication were negatively associated with glycemic target achievement. No characteristics were associated with LDL-c target achievement. Microvascular complications and antihypertensive medication prescription were negatively associated with BP target attainment. Opportunities for improvement of diabetes management exist for the achievement of glycemic, lipid, and BP targets but may differ between individuals with and without CVD.

Real-World Diabetes Technology: Overcoming Barriers and Disparities.

Real-World Diabetes Technology: Overcoming Barriers and Disparities.

A Systematic Review and Meta-Analysis of Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Type-2 Diabetes.

Diabetes mellitus (DM) has a growing prevalence worldwide, even in developing countries. Many antidiabetic agents are used to improve glycemic control; however, in cases of an insufficient outcome, insulin is administered. Yet, the timing of proper insulin administration is still a subject of intense research. To date, there have been no recommendations or guidelines for the use of continuous subcutaneous insulin infusion (CSII) in Type 2 Diabetes Mellitus (T2DM). In the present study, we have performed a meta-analysis to evaluate the use of CSII in patients with T2DM. An extensive literature search was conducted through the electronic databases Pubmed, Clinicaltrials.gov, and Cochrane Central Register of Controlled Trials (CENTRAL) from October 2019-May 2022, for interventional studies related to T2DMI and CSII versus multiple daily injections (MDI). We included articles published in the English language only, yielding a total of thirteen studies. We found better outcomes in patients receiving CSII, in regard to glycated hemoglobin (HbA1c) and total insulin dose. In contrast, fasting plasma glucose and body weight did not show statistically significant differences between the two groups. Our analyses showed that CSII could be beneficial in patients with T2DM in order to achieve their glucose targets.

In vitro Stability of Biosimilar Insulin Aspart SAR341402 in the Medtronic MiniMed Insulin Pumps

SAR341402 (Insulin aspart Sanofi®) is an insulin aspart biosimilar that can be used for continuous subcutaneous insulin infusion (CSII) in pump systems. The physicochemical stability of SAR341402 for CSII use was evaluated in several in vitro experiments. Insulin aspart products (SAR341402, NovoLog®, NovoRapid®) were filled into pump reservoirs and pumped through Medtronic insulin pumps (MiniMedTM 530G-Model 751, Medtronic, Northridge, CA) and their related infusion sets under simulated stress conditions, including elevated temperature and mechanical agitation on a continuously vibrating platform, up to 13 days. Samples pumped through the infusion sets and retained in reservoirs (non-pumped) were analyzed using suitable analytical methods. All products showed stable insulin aspart content and no unwanted impurities. Minor pH changes were seen in all products but were not considered relevant. A time-dependent increase in high-molecular-weight proteins and largest other insulin aspart impurities was observed for each product but each remained within acceptance limits. Concentrations of phenol and metacresol decreased but remained at levels to ensure preservative efficacy. Samples collected from the infusion sets were clear of visible particles and showed comparable subvisible particle counts. No occlusion events were observed. Leachable profiles from pump and reservoir samples were similar in all product batches. Like NovoLog®/NovoRapid®, SAR341402 demonstrates appropriate physicochemical stability when used in these insulin pump systems.

Diabetic Ketoacidosis at Onset of Type 1 Diabetes and Long-term HbA1c in 7,961 Children and Young Adults in the Australasian Diabetes Data Network.

The relationship between diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes and long-term glycemic control varies between studies. We aimed, firstly, to characterize the association of DKA and its severity with long-term HbA1c in a large contemporary cohort, and secondly, to identify other independent determinants of long-term HbA1c. Participants were 7,961 children and young adults diagnosed with type 1 diabetes by age 30 years from 2000 to 2019 and followed prospectively in the Australasian Diabetes Data Network (ADDN) until 31 December 2020. Linear mixed-effect models related variables to HbA1c. DKA at diagnosis was present in 2,647 participants (33.2%). Over a median 5.6 (interquartile range 3.2, 9.4) years of follow-up, participants with severe, but not moderate or mild, DKA at diagnosis had a higher mean HbA1c (+0.23%, 95% CI 0.11,0.28; [+2.5 mmol/mol, 95% CI 1.4,3.6]; P < 0.001) compared with those without DKA. Use of continuous subcutaneous insulin infusion (CSII) was independently associated with a lower HbA1c (-0.28%, 95% CI -0.31, -0.25; [-3.1 mmol/mol, 95% CI -3.4, -2.8]; P < 0.001) than multiple daily injections, and CSII use interacted with severe DKA to lower predicted HbA1c. Indigenous status was associated with higher HbA1c (+1.37%, 95% CI 1.15, 1.59; [+15.0 mmol/mol, 95% CI 12.6, 17.4]; P < 0.001), as was residing in postcodes of lower socioeconomic status (most vs. least disadvantaged quintile +0.43%, 95% CI 0.34, 0.52; [+4.7 mmol/mol, 95% CI 3.4, 5.6]; P < 0.001). Severe, but not mild or moderate, DKA at diagnosis was associated with a marginally higher HbA1c over time, an effect that was modified by use of CSII. Indigenous status and lower socioeconomic status were independently associated with higher long-term HbA1c.

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.

Insulin Pump-Associated Adverse Events in a Brazilian Reference Center for the Treatment of Diabetes Mellitus: Proposal for a Taxonomy of Device Failures in Adults, Adolescents, and Children.

Since the introduction of continuous subcutaneous insulin infusion (CSII), the benefits have been numerous. However, adverse events (AEs) are experienced by up to 40% of users per year, exposing them to potentially fatal risks. The available evidence on the variables that trigger AEs associated with CSII remains limited, indicating the importance of studies on the subject. To propose a taxonomy based on the prevalent AEs experienced by patients from a reference diabetes mellitus (DM) center in Brazil using different CSII devices. 118 patients participated in an online interview and answered the questions of the data collection instrument. Identifying categories and subcategories of analysis contributed to constructing the AEs taxonomy. The five analysis categories identified were: CSII User Interface (n = 45), CSII Alert System (n = 13), CSII Software and Connection (n = 11), CSII Durability (n = 30), and Electrical and Mechanical System of CSII (n = 60) A total of 159 AEs were identified, including conflicting alert messages and error/warning notification failures, errors resulting from engine malfunctions, data loss, patient interface deficiencies, button problems, and battery failure. The study describes in a taxonomic format the AEs directly associated with the use of modern CSIIs that may contribute with additional information to the Food and Drug Administration (FDA) Medical Device Report (MDR) adverse event codes. In addition to guiding educational actions in the treatment of DM and providing information for health professionals and medical device developers, prospective studies examining the frequency of such problems, including the potential psychosocial impact of this technologically advanced therapy, are needed.

Self-reported Severe and Nonsevere Hypoglycemia in Type 1 Diabetes: Population Surveillance Through the BETTER Patient Engagement Registry: Development and Baseline Characteristics

ObjectivesThe BETTER (BEhaviors, Therapies, TEchnologies and hypoglycemic Risk in Type 1 diabetes) registry is a type 1 diabetes population surveillance system codeveloped with patient partners to address the burden of hypoglycemia and assess the impact of new therapies and technologies. The aim of this report was to describe the baseline characteristics of the BETTER registry cohort. MethodsA cross-sectional baseline evaluation was performed of a Canadian clinical cohort established after distribution of an online questionnaire. Participants were recruited through clinics, public foundations, advertising and social media. As of February 2021, 1,430 persons ≥14 years of age and living with type 1 diabetes or latent-autoimmune diabetes (LADA) were enrolled. The trial was registered on ClinicalTrials.gov (NCT03720197). ResultsParticipants were (mean ± standard deviation) 41.2±15.7 years old with a diabetes duration of 22.0±14.7 years, 62.0% female, 92.1% Caucasian and 7.8% self-reporting as LADA, with 40.9% using a continuous subcutaneous insulin infusion (CSII) system and 78.0% using a continuous glucose monitoring (CGM) system. The most recent glycated hemoglobin ≤7% was reported by 29.7% of participants. At least 1 episode of hypoglycemia <3.0 mmol/L (level 2-H) in the last month was reported by 78.4% of participants, with a median (interquartile range) of 5 (3, 10) episodes. The occurrence of severe hypoglycemia (level 3-H) in the last 12 months was reported by 13.3% of participants. Among these, the median number of episodes was 2 (1, 3). ConclusionsWe have established the first surveillance registry for people living with type 1 diabetes in Canada relying on patient-reported outcomes and experiences. Hypoglycemia is a highly prevalent burden despite a relatively wide adoption of CSII and CGM use.

Thirty-Year Time Trends in Diabetic Retinopathy and Macular Edema in Youth With Type 1 Diabetes.

To examine trends in diabetic retinopathy (DR) and diabetic macular edema (DME) in adolescents with type 1 diabetes between 1990 and 2019. We analyzed 5,487 complication assessments for 2,404 adolescents (52.7% female, aged 12-20 years, diabetes duration >5 years), stratified by three decades (1990-1999, 2000-2009, 2010-2019). DR and DME were graded according to the modified Airlie House classification from seven-field stereoscopic fundal photography. Over three decades, the prevalence of DR was 40, 21, and 20% (P < 0.001) and DME 1.4, 0.5, and 0.9% (P = 0.13), respectively, for 1990-1999, 2000-2009, and 2010-2019. Continuous subcutaneous insulin infusion (CSII) use increased (0, 12, and 55%; P < 0.001); mean HbA1c was bimodal (8.7, 8.5, and 8.7%; P < 0.001), and the proportion of adolescents meeting target HbA1c <7% did not change significantly (8.3, 7.7, and 7.1%; P = 0.63). In multivariable generalized estimating equation analysis, DR was associated with 1-2 daily injections (odds ratio 1.88, 95% CI 1.42-2.48) and multiple injections in comparison with CSII (1.38, 1.09-1.74); older age (1.11, 1.07-1.15), higher HbA1c (1.19, 1.05-1.15), longer diabetes duration (1.15, 1.12-1.18), overweight/obesity (1.27, 1.08-1.49) and higher diastolic blood pressure SDS (1.11, 1.01-1.21). DME was associated with 1-2 daily injections (3.26, 1.72-6.19), longer diabetes duration (1.26, 1.12-1.41), higher diastolic blood pressure SDS (1.66, 1.22-2.27), higher HbA1c (1.28, 1.03-1.59), and elevated cholesterol (3.78, 1.84-7.76). One in five adolescents with type 1 diabetes had DR in the last decade. These findings support contemporary guidelines for lower glycemic targets, increasing CSII use, and targeting modifiable risk factors including blood pressure, cholesterol, and overweight/obesity.

Use of continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes mellitus: a systematic mapping review

BackgroundAmong the treatments for type 1 diabetes mellitus (T1DM), Continuous Subcutaneous Insulin Infusion (CSII) is a device that infuses insulin through the subcutaneous tissue in an uninterrupted manner and that comes closest to the physiological secretion of insulin. The use of CSII can provide the family with greater security and children and adolescents have more autonomy in relation to the treatment of T1DM. There is a lack of reviews that systematically gather the mounting evidence about the use of CSII in children and adolescents with T1DM. Therefore, the aim of this review was to group and describe primary and secondary studies on the use of CSII in children and adolescents with T1DM.MethodsA systematic mapping review was performed based on searches in the following databases: PubMed, Embase, CINAHL, Lilacs and PsycINFO, using a combination of descriptors and keywords. The screening of the studies was carried out with the aid of the Rayyan software and reading in full was conducted independently by two reviewers. The data extraction of the studies was performed using an extraction tool adapted and validated by researchers specialized in diabetes. The data were analyzed according to the content analysis technique. The map from geocoding of the studies was produced using the ArcGis 10.5 software.ResultsA total of 113 studies were included in the review, including primary studies, literature reviews and gray literature publications. The content analysis of the results of the studies allowed for the identification of four categories: 1) metabolic control; 2) support networks; 3) benefits of using CSII; and 4) challenges of using CSII, each category having its respective subcategories. The review also made it possible to conduct a rigorous mapping of the literature on the use of CSII considering the location of development and the design of the studies.ConclusionsThe use of CSII should be indicated by health professionals able to prepare children, adolescents, and their families for the treatment of T1DM, and, despite being a technological device, it may not be suitable for the entire pediatric population.

Insulin-induced Lipohypertrophy in Patients with Type 1 Diabetes Mellitus Treated with an Insulin Pump.

Background Lipohypertrophy (LH) of subcutaneous tissue is an insulin-induced complication occurring in patients with diabetes. We aimed to define the prevalence of LH and identify its risk factors in type 1 diabetes (T1DM) patients treated with continuous subcutaneous insulin infusion (CSII). Materials and Methods The study included 79 consecutive CSII-treated T1DM patients. The diagnose of LH was based on ultrasonography (US) as a reference method, physical examination was also performed. Clinical characteristics were available from the medical records. Results The median age of patients was 28 years (interquartile range [IQR], 24–30.5) with a body mass index (BMI) of 24.5 ± 3.5 kg/m2, HbA1c 7.1% (IQR, 6.7–8.1), T1DM duration 15 (9–20) years, and CSII use duration of 8 year (IQR, 5–11). LH was detected by US in 75 (94.9%) patients. This value was much higher than this obtained by visual assessment (n = 39, 49.4%) or palpation (n = 59, 74.7%). In univariate analyses, the following risk factors for occurrence of 5 and more LH lesions were identified: the ratio of insulin dose to body mass exceeding 0.7 IU/kg (OR, 3.69; 95% CI, 1.43–10.01) and the total daily insulin dose (OR, 1.05; 95% CI, 1.02–1.09). A higher dose of insulin per kg remained a significant risk factor of LH amount in multivariate analysis. Conclusion This selected T1DM cohort treated with CSII had a very high prevalence of LH. US assessment should be considered as a reference method for LH screening in T1DM patients. The identified risk factors for the number of LH lesions were related to insulin dosing.

Continuous glucose monitoring and insulin pump therapy in pregnant women with type 1 diabetes mellitus.

We examined the impact of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring systems (CGM) during pregnancy in women with pre-gestational type 1 diabetes (T1DM) on glycemic control and subsequent adverse outcomes. In this observational, one-center study we analyzed records of consecutive 109 T1DM pregnancies (2016-2017). The final analyzed group consisted of 81 singleton pregnancies who met inclusion and exclusion criteria. We searched for the association between the use of CSII with or without CGM and pregnancy planning with glycated hemoglobin A1c (HbA1c) through pregnancy and after delivery as well as maternal and infant outcomes. Patients using CSII and CGM vs CSII without CGM and MDI (multiple daily injections) users had the lowest HbA1c levels during and after pregnancy (5.3%, 5.3%, 5.2% and 5,5% in the 1st, 2nd, 3rd trimester and postpartum visit, p = 0.003, p = 0.030, p = 0.039 and p = 0.002, respectively). Patients treated with insulin pumps with CGM and additional functions of automatic insulin delivery suspension on low glucose level (SLG) or predictive low glucose suspend (PLGS) during the third trimester and after pregnancy achieved a significantly lower HbA1c than the other CSII patients. We did not find any differences between the study groups in gestational age at delivery, preterm births, birth weight or macrosomia risk. Despite very good glycemic control, the risk of macrosomia remained high (19.7%). The use of pumps equipped with CGM, especially with automatic insulin delivery suspension, may improve glycemic control in pregnant T1DM women. The proportion of macrosomia remained high.

Continuous subcutaneous insulin infusion alters microRNA expression and glycaemic variability in children with type 1 diabetes

To determine whether continuous subcutaneous insulin infusion (CSII) vs. multiple daily injections (MDI) therapy from near-diagnosis of type 1 diabetes is associated with reduced glycaemic variability (GV) and altered microRNA (miRNAs) expression. Adolescents (74% male) within 3-months of diabetes diagnosis (n = 27) were randomized to CSII (n = 12) or MDI. HbA1c, 1-5-Anhydroglucitol (1,5-AG), high sensitivity C-peptide and a custom TaqMan qPCR panel of 52 miRNAs were measured at baseline and follow-up (median (LQ-UQ); 535 (519–563) days). There were no significant differences between groups in baseline or follow-up HbA1c or C-peptide, nor baseline miRNAs. Mean ± SD 1,5-AG improved with CSII vs. MDI (3.1 ± 4.1 vs. − 2.2 ± − 7.0 mg/ml respectively, P = 0.029). On follow-up 11 miRNAs associated with diabetes vascular complications had altered expression in CSII-users. Early CSII vs. MDI use is associated with lower GV and less adverse vascular-related miRNAs. Relationships with future complications are of interest.