Characteristics of people with type 1 diabetes who use technology in their treatment and who use frequently the technical assistance teleconsultation service.

INTRODUCTION: Technical issues related to continuous subcutaneous insulin infusion (CSII), associated or not with continuous glucose monitoring (SAP), are handled by tele-technical assistance from the manufacturer. We analyze the characteristics of the most demanding patients of technical teleassistance. MATERIAL AND METHODS: Patients with type 1 diabetes (T1D) in treatment with CSII or SAP, who made use of technical teleassistance from 01/01/2017 to 02/28/2021 (2298 consultations) were included. We selected the group of patients who made ≥10 calls (90th percentile, P90) and the one who made a single call (10th percentile, P10). The number and most frequent reasons for consultation, clinical characteristics and HbA1c were collected and both groups were compared. RESULTS: 51 patients (P90) made a total of 876 calls (38.1% of calls), 32 used SAP. The most frequent reason for consultation was related to continuous glucose monitoring (36.8%). 51 (P10) made 51 calls (2.2%), 3 used SAP. The most frequent reason for consultation was related to device damage (25.5%). The most demanding patients used SAP more frequently (62.7 vs. 5.9%, P < .001), had been in advanced treatment for less time (7.1 ±â€¯5.5 vs. 12.1 ±â€¯6.2 years, P < .001) and their HbA1c was lower (7.2 ±â€¯0.9 vs 7.6 ±â€¯0.8%). CONCLUSIONS: Most of the calls to the technical teleassistance service for ISCI/SAP devices come from a more demanding group of people with T1D. The greatest demand is concentrated in patients who use SAP, with a shorter time of use of advanced therapy and a better degree of glucose control.

Responsabilidades de autocuidado acordes a la edad en población pediátrica con diabetes tratada con ISCI / Age-appropriate self-care responsibilities in the pediatric population with diabetes treated with CSII

Objetivo: Determinar en población infantil con Diabetes tipo 1 (DT1) en tratamiento con infusión subcutánea continua de insulina (ISCI), si asumir responsabilidades de autocuidado tras recibir un programa estructurado de educación terapéutica (PEET) se relaciona con el control metabólico y la calidad de vida (CV). Métodos: Estudio observacional, transversal. Se realizó un sub-análisis retrospectivo. Se incluyeron sujetos con DT1 (edad 9-17 años) en terapia ISCI (>1año) que habían recibido el mismo PEET al inicio de ISCI. Se registraron: grado en que asumían responsabilidades de autocuidado acordes a su edad, control metabólico, CV, nivel de conocimientos sobre diabetes y uso de funciones específicas del dispositivo. Resultados: Se incluyeron 44 pacientes. Los niños que asumieron responsabilidades de autocuidado acordes a su edad presentaron valores de hemoglobina glicada (HbA1c) significativamente menores que los niños que no las asumieron (8,0±0,7% vs. 9,2±1,1%, respectivamente, p<0,001), así como una mayor puntuación en los cuestionarios de CV y de conocimientos (CV 84,3±9,3 vs. 79,4±10,6, p<0,01; conocimientos 27,9±4,2 vs. 26,5±4,3, respectivamente, n.s). El uso de las funciones específicas de la bomba se observó principalmente en aquellos que asumieron esas responsabilidades de autocuidado presentando valores más bajos de HbA1c que aquellos niños que no las utilizaron (7,9±1,0% vs. 8,4±0,8%, p<0,05). Conclusiones: Los pacientes con DT1 en tratamiento con ISCI que asumieron responsabilidades de autocuidado de su diabetes acorde a su edad, mostraron mejor control de HbA1c y mejor CV que aquellos que no lo hicieron. Se necesitan más estudios para profundizar en el conocimiento de estos aspectos. (AU)

Objective: The aim of this study was to determine if children and adolescents with type 1 diabetes (DT1) managed with continuous subcutaneous insulin infusion (ISCI) who assume self-care responsibilities tailored to the age after a specific structured education program (PEET), present better metabolic control and quality of life (CV). Methods: A observational, cross-sectional study was conducted. A retrospective sub-analysis was performed. Subjects with DT1 (aged 9-17 years) who have been using ISCI (>1year) were included. All patients received the same structured PEET when initiating ISCI treatment. The degree of self-care age-appropriate responsibilities assumed by children was registered. Data related to metabolic control, diabetes knowledge, use of different pump features, and quality of life were also collected. Results: Forty-four patients were included. Children assuming age-appropriate self-care responsibilities had a significantly lower glycated hemoglobin (HbA1c) value compared to those children who did not take on these responsibilities (8,0±0,7% vs. 9,2±1,1%, p<0,001). as well as higher scores in the CV and knowledge questionnaires (84,3±9,3 vs. 79,4±10,6 respectively, p<0,01; knowledge 27,9±4,2 vs. 26,5±4,3, respectively, n.s). The use of specific pump features was mainly observed in those who assumed age-appropriate self-care responsibilities and showed lower HbA1c values than those children who did not take on these responsibilities (7,9±1,0% vs. 8,4±0,8%, p<0,05). Conclusion: Patients with DT1 managed with ISCI, who assumed age-appropriate responsibilities on disease self- management, showed better HbAc1 and better CV than those who did not. More studies are needed to deepen the knowledge of these topics. (AU)

Assessment of the effectiveness of long-term insulin pump therapy using a combined goal of HbA1c decrease and absence of severe hypoglycemia. / Evaluación de la efectividad de la terapia ISCI a largo plazo mediante el objetivo combinado de descenso de HbA1c y ausencia de hipoglucemia grave.

OBJECTIVE: Less than one third of patients with type 1 diabetes mellitus (T1DM) achieve the cut-off value proposed as good metabolic control by most guidelines, HbA1c<7%. However, HbA1c reductions and prevention of severe hypoglycemia (SH) have shown clinically relevant benefits. The study objective therefore was to assess the effectiveness of continuous subcutaneous insulin infusion (CSII) therapy at 5 years of follow-up in a cohort of patients attending a specialized unit using HbA1c reduction and abscence of SH as combined goals. METHODS: A retrospective, observational study on 178 patients with T1DM who started CSII treatment at Hospital Clinic of Barcelona between 2003 and 2008. HbA1c levels at baseline and after 5 years of treatment with CSII and presence or absence of SH were recorded. The combined variables calculated included: a) HbA1c reduction by≥0.5 points and absence of SH in the last 2 years; b) HbA1c at 5 years<7.5% and no SH in the last 2 years; c) HbA1c<8.5% and no HG in the last 2 years, and d) HbA1c reduction by≥0.5 points and/or HbA1c<7.5% at 5 years with no SH in the last 2 years of follow-up. RESULTS: Twenty-seven of the 178 patients were excluded due to loss to follow-up or CSII discontinuation. A total of 151 patients (aged 37.4±10.5 years, 64% women, diabetes duration of 19.2±10.7 years) were therefore analyzed. The 2 main reasons for starting CSII were suboptimal metabolic control (60.9%) and severe hypoglycemia/hypoglycemia unawareness (28.5%). HbA1c levels in the total cohort and in patients with suboptimal metabolic control were 8.0±1.2 and 8.4±1.1% at CSII start and 7.8±1.2 and 8.0±1.3% at 5 years of treatment (P=.104 and P=.016) respectively. In the overall cohort, 55.5% of patients achieved at 5 years the combined goal of HbA1c<7.5% and/or HbA1c reductions≥0.5% without SH. CONCLUSIONS: After 5 years of CSII therapy, more than half of the patients achieved the combined goal of significant HbA1c reduction and absence of SH. The use of combined goals offers the opportunity to assess the effectiveness of T1DM treatment from a clinically more meaningful point of view.

Experiences and real life management of insulin pump therapy in adults with type 1 diabetes.

OBJECTIVE: There is scarce information regarding the performance of a specific, structured education program addressed to patients with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) including both routine use of the therapy and patient experience evaluation. We aimed to assess the routine use of CSII and patient's experience and satisfaction regarding a specific structured patient self-management education and care program. METHODS: A retrospective, observational, cross-sectional study collecting CSII routine use downloaded data. Patient experience and satisfaction were evaluated using an anonymous online survey covering different aspects of CSII self-management education and care program. RESULTS: 380 T1D subjects were included (aged 45.3±12.17 years, 62.1% women, diabetes duration 27.8±10.3 years, 9.7±4.7 years on CSII, HbA1c 7.7+1.0%; 61.0±7.9mmol/mol). Participants with HbA1c≤7.5% (58mmol/mol, n=178) did more SMBGs per day (4.4±2.1 vs. 3.9±1.9); used more boluses (5.0±1.8 vs. 4.5±2.0); the percentage of insulin given as bolus was higher (50.1±12.8 vs. 44.9±13.2%); the night bolus wizard (BW) high glucose target was lower (125.9±4.4 vs. 130.5±12.8mg/dl) and time on CSII therapy was shorter (8.9±4.6 vs. 10.3±4.6 years. p<0.05 all comparisons). More SMBG/day, shorter duration of CSII treatment, a lower BW low glucose target at night, a lower BW high glucose target at night, total insulin dose per day and total number of carbohydrates per day were related with better HbA1c levels. 60% of 373 patients answered the questionnaire. The response to the different aspects of the educational program was homogeneously highly satisfactory. Seventy-seven percent of patients scored the program as very useful. Ninety-three percent of CSII users would not return to their previous insulin treatment. CONCLUSIONS: The analysis of routine clinical use of CSII by T1D patients demonstrates that glucose control may be associated with some pump usage and adherence parameters. The overall user experience and satisfaction with our CSII self-management education and care program was remarkably favorable.

Cost-effectiveness analysis of sensor-augmented pump therapy with low glucose-suspend in patients with type 1 diabetes mellitus and high risk of hypoglycemia in Spain.

OBJECTIVE: To compare the cost-effectiveness of sensor-augmented pump therapy (SAP) [continuous subcutaneous insulin infusion (CSII) plus real-time continuous glucose monitoring (RT-CGM)] with low glucose suspend (MiniMed™ Veo™) and CSII alone in patients with type 1 diabetes mellitus (T1DM) at high risk of hypoglycemia in Spain. METHODS: The IQVIA CORE Diabetes Model was used to estimate healthcare outcomes as life-years gained (LYGs) and quality-adjusted life years (QALYs), and to project lifetime costs. Information about efficacy, resource utilization, and unit costs (€2016) was taken from published sources and validated by an expert panel. Analyses were performed from both the Spanish National Health System (NHS) perspective and the societal perspective. RESULTS: From the NHS perspective, SAP with low glucose suspend was associated to a €47,665 increase in direct healthcare costs and to increases of 0.19 LYGs and 1.88 QALYs, both discounted, which resulted in an incremental cost-effectiveness ratio (ICER) of €25,394/QALY. From the societal perspective, SAP with low glucose suspend increased total costs (including direct and indirect healthcare costs) by €41,036, with a resultant ICER of €21,862/QALY. Considering the willingness-to-pay threshold of €30,000/QALY in Spain, SAP with low glucose suspend represents a cost-effective option from both the NHS and societal perspectives. Sensitivity analyses confirmed the robustness of the model. CONCLUSIONS: From both the Spanish NHS perspective and the societal perspective, SAP with low glucose suspend is a cost-effective option for the treatment of T1DM patients at high risk of hypoglycemia.

Budget impact of continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes who experience severe recurrent hypoglycemic episodes in Spain. / Impacto presupuestario de la infusión subcutánea continua de insulina en el tratamiento de pacientes con diabetes tipo 1 que presentan episodios de hipoglucemia grave recurrente en España.

OBJECTIVE: Hypoglycemia is one of the most common complications to achieve a good metabolic control, and has been listed by several scientific associations as a common indication to start treatment with continuous subcutaneous insulin infusion (CSII). Use of CSII is still residual in Spain as compared to neighbouring countries, and cost of acquisition cost is one of the main reasons. This study estimates the budget impact of treatment with CSII, as compared to multiple daily insulin injections, of patients with type 1 diabetes mellitus who experience recurrent severe hypoglycemia episodes from the National Healthcare System perspective. METHODS: Budget impact was based on a retrospective, observational study evaluating the efficacy of CSII in patients with type 1 diabetes mellitus conducted at Hospital Clínic i Universitari in Barcelona, where one of the main indications for switching to CSII were recurrent severe hypoglycemia episodes. The mean number of annual episodes was 1.33 in the two years prior to CSII start and 0.08 in the last two years of follow up (p=0.003). Costs of treatment and major hypoglycemic events over a four-year period were considered. Costs were taken from different Spanish data sources and expressed in € of 2016. RESULTS: Treatment with CSII increased costs by €9,509 per patient as compared to multiple daily insulin injections (€11,902-€2,393). Cost associated to severe hypoglycemic events decreased by €19,330 per patient treated with CSIII (€1,371-€20,701). Results suggest mean total savings of €9,821 per patient during the four-year study period. CONCLUSION: The higher costs associated to CSII therapy may be totally offset by the severe hypoglycemic events prevented.

[Current status of continuous subcutaneous insulin infusion and continuous glucose monitoring systems in the Community of Madrid]. / Estado actual de los sistemas de infusión subcutánea continua de insulina y monitorización continua de glucosa en la Comunidad de Madrid.

OBJECTIVE: To analyze the available information about continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems in the public health care system of the Community of Madrid. MATERIAL AND METHODS: A survey consisting of 31 items was sent to the 28 endocrinology department of the Madrid public hospitals. Items focused on CSII and CGM and included patients' registrations, as well as data regarding healthcare, administrative, and logistic aspects. Responses from a total of 20 hospitals where these procedures are used were received from March 2013 to May 2014. Data about pediatric patients were obtained from adult endocrinology departments, except for two hospitals which directly reported the information. RESULTS: A total of 1256 CSII pumps were recorded in the Madrid region, of which 1089 were used by adults, and the remaining 167 by pediatric patients. During 2013, 151 new CSII systems were implanted (12% of the total), while 14 pumps were withdrawn. Availability of human resources (medical assistance) and the number of staff practitioners experienced in management of these systems widely varied between hospitals. Eighty-five percent of hospitals used retrospective CGM systems, and 40% routinely placed them before starting an insulin pump. Thirteen hospitals (65%) used long-term, real-time CGM systems in selected cases (a total of 67 patients). CONCLUSIONS: Use of these technologies in diabetes is unequal between public health care hospitals in Madrid, and is still significantly lower as compared to other countries with similar incomes. However, there appears to be a trend to an increase in their use.

An observational 7-year study of continuous subcutaneous insulin infusion for the treatment of type 1 diabetes mellitus.

UNLABELLED: This work reports the experience with use of continuous subcutaneous insulin infusion (CSII) in 112 type 1 diabetic patients followed up for 7 years and previously treated with multiple daily insulin injections (MDII). MATERIAL AND METHODS: A retrospective, observational study in 112 patients with diabetes mellitus treated with CSII from 2005 to 2012, previously treated with MDII and receiving individualized diabetic education with a specific protocol. Variables analyzed included: prevalence of the different indications of pump treatment; mean annual HbA1c and fructosamine values before and after CSII treatment; and hypoglycemia frequency and symptoms. RESULTS: The most common reason for pump treatment was brittle diabetes (74.1%), followed by frequent or severe hypoglycemia or hypoglycemia unawareness (44.6%). Other indications were irregular food intake times for professional reasons (20.2%), dawn phenomenon (15.7%), pregnancy (12.3%), requirement of very low insulin doses (8.9%), and gestational diabetes (0.9%). HbA1c decreased by between 0.6% and 0.9%, and fructosamine by between 5.1% and 12.26%. Nine percent of patients experienced hypoglycemia weekly, 24% every two weeks, and 48% monthly. No hypoglycemia occurred in 19% of patients. Only 10% had neuroglycopenic symptoms. Hypoglycemia unawareness was found in 21%. Hypoglycemia was more common at treatment start, and its frequency rapidly decreased thereafter. CONCLUSION: CSII therapy provides a better glycemic control than MDII treatment. Specific patient training and fine adjustment of insulin infusion doses are required to prevent hypoglycemic episodes, which are the most common complications, mainly at the start of treatment.