Continuous glucose monitoring (CGM) has demonstrated to improve glucose control in people with type 2 diabetes (T2D) especially in those on insulin therapy. Dexcom ONE + is a CGM system with some particular features, however, there is no clinical study conducted with this device. The aim was to determine whether Dexcom ONE + can improve glucose control and patient-reported outcomes in insulin-treated T2D subjects. Prospective, multicenter study including T2D on multiple insulin injections (MDI) or basal insulin (BI), without CGM experience and HbA1c > 7
Introducción Los pacientes con diabetes mellitus (DM) y enfermedad arterial periférica (EAP) constituyen un grupo de muy alto riesgo cardiovascular frecuentemente infratratado desde el punto de vista lipídico. Objetivo Analizar el grado de control lipídico en pacientes con DM hospitalizados por EAP y estimar las modificaciones necesarias en el tratamiento hipolipemiante para alcanzar los objetivos recomendados. Métodos Estudio observacional retrospectivo que incluyó a todos los pacientes con DM ingresados por EAP en un hospital terciario durante 2023. Se recogieron variables demográficas, analíticas y el tratamiento hipolipemiante al ingreso. Se evaluó la consecución de objetivos lipídicos, los cambios terapéuticos necesarios para alcanzar el objetivo de colesterol LDL (c-LDL) y los candidatos a icosapento de etilo. Resultados Se incluyeron 118 pacientes (edad media 76±9,5 años; 72,9% varones; 96,6% DM2; HbA1c 7,2% [6,2-8]). El 91,5% disponía de perfil lipídico previo al ingreso. El 75% presentaba c-LDL ≥55mg/dL (n=81); de estos, solo el 34,6% recibía estatinas de alta intensidad, el 12,35% tratamiento combinado con estatina y ezetimiba, y un único paciente estaba en tratamiento con inhibidores de PCSK9. El 22,7% cumplía criterios para iniciar icosapento de etilo. Conclusión La mayoría de los pacientes con DM ingresados por EAP no alcanzan los objetivos lipídicos recomendados debido a una infrautilización de terapias hipolipemiantes intensivas y combinadas. La hospitalización representa una oportunidad para optimizar el tratamiento hipolipemiante en esta población de muy alto riesgo cardiovascular.
OBJECTIVE:To evaluate real-world glycemic outcomes, safety, treatment satisfaction, cognition, and frailty in older adults with type 1 diabetes (T1D) using advanced hybrid closed-loop (aHCL), and to compare them with those of matched older adults treated with multiple daily injections (MDIs). RESEARCH DESIGN AND METHODS:Multicenter observational study including 100 adults with T1D from 19 Spanish hospitals who initiated aHCL at ≥65 years and 100 age- and sex-matched MDI users. Glycemic outcomes before aHCL initiation were compared with the final follow-up. Final glycemic outcomes were also compared between the aHCL and MDI groups. Cognitive function and frailty were assessed using the Montreal Cognitive Assessment and FRAIL scales. RESULTS:Mean age was 71.2 ± 4.4 years. In aHCL users, time in range (TIR 70-180 mg/dL) increased from 65.3% ± 15.0% before aHCL initiation to 78.6% ± 10.5% at the final follow-up (P < 0.001), and HbA1c decreased from 7.56% ± 0.97% to 7.01% ± 0.59% (59.1 ± 10.6 mmol/mol to 53.1 ± 6.4 mmol/mol) (P < 0.001). At the final follow-up, aHCL users had a higher TIR than matched MDI users (78.6% ± 10.5% vs. 63.0% ± 18.1%; P < 0.001) and lower HbA1c (7.01% ± 0.59% vs. 7.65% ± 0.98%; 53.1 ± 6.4 mmol/mol to 59.9 ± 10.7 mmol/mol; P < 0.001). Severe hypoglycemia decreased from 28.0 to 1.6 events per 100 patient-years after aHCL initiation. A total of 60% of aHCL users had mild-to-moderate cognitive impairment, yet the final TIR was similar across cognitive strata within the aHCL group. CONCLUSIONS:In older adults with T1D, real-world aHCL initiation was associated with improved glycemic outcomes and better glycemic outcomes than in matched MDI users in a cohort with substantial cognitive vulnerability. These findings support the effectiveness of aHCL therapy in routine geriatric diabetes care.
OBJECTIVE:The main challenge in type 1 diabetes mellitus management is achieving and maintaining glycemic control. Hybrid closed-loop (HCL) systems offer patients the potential to safely achieve tight glycemic targets. This study analyzed the clinical and economic impact of HCL systems compared with intermittently scanned continuous glucose monitoring (is-CGM) and continuous subcutaneous insulin infusion (CSII) therapy from the Spanish health care system perspective. METHODS:IQVIA Core Diabetes Model v10.0 was used to simulate a cohort of 1000 individuals assigned to either the HCL or is-CGM+CSII therapy. Different time horizons were analyzed: 5, 15, 30, and 50 years. Cohort characteristics were extracted from published literature, and a 1.5% glycated hemoglobin A1C reduction was considered for the HCL group over is-CGM+CSII. RESULTS:In the HCL group, complications were averted or delayed across all time horizons whereas survival, quality of life, and cost savings were increased. At 50 years, HCL group survival was double than the comparator and 1.15 incremental quality-adjusted life years were gained. Cost savings were the highest at 50 years (28 704 922€/1000 individuals) mostly attributable to lower amputation, ulcer, and nephrological event rates. The current study is based on real-world evidence data with a median follow-up of 5.1 months. Thus, the long-term projections of clinical and economic outcomes may be affected by uncertainty. Additionally, the study did not include any hypoglycemia or diabetic ketoacidosis rates, which may lead to underestimation of the real impact of HCL systems. CONCLUSION:HCL systems should be considered the primary treatment option compared with is-CGM+CSII therapy for people with type 1 diabetes mellitus in Spain.
BACKGROUND:Automated insulin delivery (AID) systems are the most effective treatment for type 1 diabetes (T1D). When targets are not achieved, transitioning between AID systems is an option. The aim was to assess the impact of switching between systems on glucose control and user satisfaction. METHODS:A multicenter, cross-sectional analysis was conducted. T1D subjects who had switched between AID systems were included. Glycaemic control was compared before the switch, after 14 days, and after 3 months of use of the new system. The participants completed a satisfaction survey. RESULTS:96 subjects were included (age: 40.8 ± 11.5 years, 73 % female, HbA1c: 6.94 ± 0.68 % (52.3 ± 7 mmol/mol)). The AID systems evaluated included MiniMedTM-780G, Diabeloop-DBLG1, Tandem-t:slim-x2TM-Control-IQTM, and CamAPS-FX. GMI improved from 6.92 ± 0.49 % to 6.71 ± 0.37 % after 14 days and to 6.68 ± 0.36 % after 3 months and Time in Range 70-180 mg/dl increased from 70.53 ± 11.43 % to 75.73 ± 8.33 % after 14 days and to 75.65 ± 7.64 % after 3 months (p < 0.001 to baseline). The majority of the participants reported higher satisfaction. The factors that most affected satisfaction were the size of the system, the performance of the sensor, and the specificities of the control algorithm. CONCLUSION:Transitioning between AID systems can enhance glucose control and user satisfaction without compromising glycaemic stability during the adjustment period.
ABSTRACTContextRetinal microperimetry (MPR) is a non‐invasive method that measures retinal light sensitivity (RS) and gaze fixation stability (GFS). MPR has been described as a marker of cognitive impairment in people with Type 2 diabetes, but it has never been assessed in people with Type 1 diabetes (T1D). Our group described subclinical cognitive alterations, structural brain differences, and increased levels of light chain neurofilament (NfL) in people with T1D and impaired awareness of hypoglycaemia.ObjectiveTo measure RS and GFS using MPR in individuals with T1D and evaluate its correlation with neuropsychological assessment, plasma NfL levels and CGM‐derived glucometric parameters. Secondary objectives: to evaluate the possible differences of RS and GFS in people with T1D depending on hypoglycaemia awareness.Design, Setting and ParticipantsPilot observational study, people with T1D without clinical cognitive impairment, moderate–severe retinopathy or glaucoma. MPR was performed with MAIA3.ResultsA total of 30 subjects were studied: 40% women, age 58 ± 11 years; T1D duration 31 ± 9 years, mild retinopathy 33%. RS was 27.5 dB (26.1–28.3) and GFS(%) 97.6% (93.5%–99.5%). We found a correlation between RS and memory alteration tests (p = 0.016) and between GFS(%) and a composite of attention and executive neuropsychological tests (p = 0.025). An inverse correlation between GFS and time below range was found. No correlation was found with NfL.ConclusionThis first exploratory study in people with T1D supports the potential utility of MPR as a screening tool for subclinical neurocognitive alterations in this population.
Objective: To assess real-world safety and effectiveness of dapagliflozin in people living with type 1 diabetes mellitus (T1DM). Methods: We conducted a multicenter retrospective study in Spain including data from 250 people living with T1DM receiving dapagliflozin as add-on therapy to insulin (80.8 % on-label use). The number of diabetic ketoacidosis (DKA) events was calculated over a 12-month follow-up (primary outcome). Changes in body weight, HbA1c, total daily insulin dose, and continuous glucose monitoring (CGM) metrics from baseline (at dapagliflozin prescription) to 12 months were also evaluated. Results: A total of five DKA events (2.4 % [95 % CI 0.3;4.5] were reported in patients with a 12-month follow-up, n = 207): two events related to insulin pump malfunction, two events related to concomitant illnesses, and one event related to insulin dose omission. DKA events were more frequent among insulin pump users than among participants on multiple daily injections (7.7 % versus 1.2 %). Four of the reported DKA events occurred within the first six months after initiation of dapagliflozin. No deaths or persistent sequelae due to DKA were reported. No severe hypoglycemia episodes were reported. Significant reductions in mean body weight (-3.3 kg), HbA1c (-0.6 %), and total daily insulin dose (-8.6 %), P < 0.001, were observed 12 months after dapagliflozin prescription. Significant improvements in TIR (+9.3 %), TAR (-7.2 %), TBR (-2.5 %), and coefficient of variation (-5.1 %), P < 0.001, were also observed in the subgroup of patients with available CGM data. Finally, an improvement in urinary albumin-to-creatinine ratio (UACR) was found among participants with UACR >= 30 mg/ g at baseline (median decrease of 99 mg/g in UACR, P = 0.001). Conclusion: The use of dapagliflozin in people living with T1DM has an appropriate safety profile after careful selection of participants and implementation of strategies to reduce the risk of DKA (i.e., prescribed according to the recommendations of the European Medicines Agency), and also leads to clinical improvements in this population.
Abstract Purpose We aimed to evaluate, in women with thyroid disorders the relationship between maternal thyroid status in each trimester and GWG according to Institute of Medicine (IOM).Methods Retrospective analysis of 782 pregnant women either receiving treatment with levothyroxine or attended because of hyperthyroidism. We used four summary measures of maternal thyroid status as predictors of GWG according to IOM: individual trimesters/at some point during pregnancy, subclinical and overt conditions combined/split.Results In women treated with levothyroxine, associations between maternal thyroid status and GWG were observed in three models. As an example, hyperthyroidism (subclinical/overt combined) in the second trimester, was associated with both insufficient (aOR: 2.96, 95% CI: 1.07–8.22) and excessive GWG (aOR: 3.25, 95% CI: 1.10–9.62). In women followed by hyperthyroidism, associations were observed in the four models. As an example, overt hypothyroidism at some point during pregnancy was associated with both insufficient GWG (aOR: 10.61, 95% CI: 2.23–50.36) and excessive GWG (aOR: 5.36, 95% CI: 1.34–21.51).Conclusions In these cohorts of pregnant women treated with levothyroxine or attended for hyperthyroidism, both maternal hypo and hyperthyroidism status display strong associations with GWG according to IOM both in expected and unexpected directions.
Purposeto evaluate changes in retinal microvasculature and sensitivity (RS) preceding the appearance of diabetic retinopathy (DR) among patients with type 1 diabetes (T1D).Methodsin this observational cross-sectional cohort study, vascular parameters measured by OCTA and RS evaluated by microperimetry were assessed in patients with T1D without DR (no-DR), T1D with mild DR (m-DR), and healthy controls.ResultsSixty-two eyes of 31 patients with T1D and 40 eyes of 20 healthy patients were included. OCTA examinations did not yield any significant differences in terms of perfusion density (PD), vascular density (VD), foveal avascular zone (FAZ) area, FAZ perimeter or FAZ circularity between patients with diabetes (no-DR vs. m-DR). However, comparisons between healthy controls and patients with diabetes (both no-DR and m-DR groups) revealed statistically significant differences in PD, VD, and FAZ area. Similarly, no significant differences were observed between no-DR and m-DR groups regarding RS, gaze fixation stability (GFS), or macular integrity (MI). Nevertheless, mean RS and MI were significantly impaired in patients with T1D, both in no-DR and m-DR groups, compared to healthy controls. A statistically significant positive correlation was observed between RS and PD and between FAZ area and RS.Conclusionalthough no differences were found between patients with diabetes without DR and those with mild DR, these patients already demonstrated some degree of retinal impairment, both structural and functional, when compared to healthy controls. Our data support the hypothesis that neurodegeneration occurs together with microvascular damage at early stages of diabetes.
Background. Advanced hybrid closed-loop systems (AHCL) have been shown to improve glycaemic control and patient-reported outcomes in type 1 diabetes (T1D). The aim was to analyse the outcomes of two commercially available AHCL in real-life. Methods. A prospective study was performed, including adolescents and adults with T1D, AHCL-naïve, from 14 centres, who initiated the use of MM780G with SmartGuardTM or Tandem t:slimX2TM with Control-IQ. Baseline and 3-month evaluations were performed, assessing HbA1c, time in different glycaemic ranges, and patient-reported outcomes. The primary outcome was the between-group time in range 70-180 mg/dl (TIR) difference from beginning to end of follow-up. Results. 150 participants were included, with 75 initiating each system (age: 39.9±11.4 years (16-72), 64% female, diabetes duration: 21.6±11.9 years). TIR increased from 61.53±14.01% to 76.17±9.48% (p<0.001), with no between-group differences (p=0.591). HbA1c decreased by 0.56% (95%CI: 0.44%,0.68%) (6 mmol/mol, 95%CI: 5,7) (p<0.001), from 7.43±1.07% to 6.88±0.60% (58±12 to 52±7 mmol/mol) in the MM780G group, and from 7.14±0.70% to 6.56±0.53% (55±8 to 48±6 mmol/mol) in the Control-IQ group (both p<0.001 to baseline, p=0.819 between groups). No superiority of one AHCL over the other regarding fear of hypoglycaemia or quality of life was found. Improvement in diabetes-related distress was higher in Control-IQ users (p=0.012). Sleep quality was improved (PSQI: from 6.94±4.06 to 6.06±4.05, p = 0.004), without differences between systems. Experience with AHCL, evaluated by the INSPIRE measures, exceeded the expectations. Conclusion. The two AHCL provide significant improvement in glucose control and satisfaction, with no superiority of one AHCL over the other. Keywords: type 1 diabetes, closed-loop system, glucose control, patient-reported outcomes. Article Highlights • Why did we undertake this study? Advanced hybrid closed-loop (AHCL) therapy should be offered to all people living with type 1 diabetes. Up to date, information about direct comparison between different AHCL options is scarce. • What did we find? Here, we describe the effect of MM780G with SmartGuardTM and the Tandem t:slimX2TM with Control-IQ over glycemic control and patient-reported outcomes among adolescents and adults with type 1 diabetes. • What are the implications of our findings? The two AHCL systems provide significant improvement in glucose control and satisfaction, with no superiority of one system over the other.
Aim: To evaluate the efficacy, safety and satisfaction of the closed-loop system Accu-Chek((R)) Insight with Diabeloop (TM) (DBLG1 (TM)) in adults with type 1 diabetes (T1D) in real-world conditions. Methods: Patients with T1D using DBLG1 for at least 3 months were included. Glucometric parameters were analyzed at baseline, 1, 2, and 3 months after starting DBLG1. HbA(1c) was measured before and at 3 months. Technical issues and acute complications were recorded and patients completed a satisfaction questionnaire. Results: Sixty-two patients were included (43 women; age 44.2 +/- 11 years; diabetes duration 24.6 +/- 12 years; 40 used flash and 22 continuous glucose monitoring (CGM); 45 were on insulin pump and 17 on multiple daily injections). A significant improvement was observed in the CGM-derived glucose metrics early in the first month: Time in range (%TIR) 70-180 mg/dL (54.86 +/- 17 vs. 72.23 +/- 10.11); time above range level 1 (%TAR1) 180-250 mg/dL (26.26 +/- 13.3 vs. 19.48 +/- 6.78), time above range level 2 (%TAR2) > 250 mg/dL (12.02 +/- 13.09 vs. 6.14 +/- 5.23), time below range level 1 (%TBR 1) 54-70 mg/dL (5.73 +/- 11.5 vs. 1.67 +/- 1.3), time below range level 2 (%TBR2) < 54 mg/dL (1.18 +/- 1.97 vs.0.44 +/- 0.49), %CV (38.66 +/- 7.53 vs. 29.63 +/- 3.74), median glucose (168.57 +/- 36 mg/dL vs. 154.63 +/- 17.55 mg/dL), and %GMI (7.37 +/- 0.91 vs. 7.02 +/- 0.42). Also, HbA(1c) decreased significantly (7.45% +/- 1.05% vs. 6.95% +/- 0.7%). No acute complications or serious adverse events occurred. Similar improvement was observed regardless of prior therapy or the glucose monitoring system used. Three patients discontinued DBLG1 and 21 experienced technical issues. Overall, patient satisfaction was high. Adjustments of the settings were modified in general in the direction of greater aggressiveness. Conclusions: A significant improvement in glycemic control without serious adverse events and a high degree of patient satisfaction were observed in this first real-world study evaluating the closed-loop system, Accu-Chek Insight with Diabeloop.
PURPOSE:To assess predictors of gestational weight gain (GWG), according to the Institute of Medicine (IOM) 2009, in women with type 1 and type 2 diabetes.METHODS:This was a retrospective cohort study conducted at a tertiary center. GWG based on the IOM was assessed both uncorrected and corrected for gestational age. General and diabetes-related clinical characteristics were analyzed as predictors.RESULTS:We evaluated 633 pregnant women with type 1 and type 2 diabetes. GWG uncorrected for gestational age was inadequate (iGWG) in 20.4%, adequate in 37.1%, and excessive (eGWG) in 42.5% of the women. Predictors included general (height, prepregnancy body mass index category, and multiple pregnancy) and diabetes-related clinical characteristics. Neuropathy and follow-up length were associated with iGWG (odds ratio (OR) 3.00, 95% CI 1.22-7.37; OR 0.92, 95% CI 0.86-0.97, respectively), while pump use and third-trimester insulin dose were associated with eGWG (OR 1.68, 95% CI 1.07-2.66; OR 3.64, 95% CI 1.88-7.06, respectively). Independent predictors for corrected GWG and sensitivity analyses also included general and diabetes-related clinical characteristics.CONCLUSION:In this cohort of women with type 1 and type 2 diabetes, non-adequate GWG was common, mainly due to eGWG, and associated clinical characteristics were both general and diabetes-related. Current clinical care of these women during pregnancy may favor weight gain.
Undoubtedly, technological advances have revolutionised diabetes management in recent years. The development of advanced closed hybrid loop insulin pumps or continuous glucose monitoring (CGM) systems, among others, have increased the quality of life and improved glycaemic control of people with diabetes. However, only some patients have access to such technology, and only some want to use it. CGM has become much more widespread, but in terms of insulin delivery, most people with type 1 diabetes (T1D) and almost all people with type 2 diabetes (T2D) on insulin therapy are treated with multiple-dose insulin injections (MDI) rather than an insulin pump. For these patients, using connected insulin pens or caps has shown benefits in reducing missed insulin injections and promoting correct administration over time. In addition, using these devices improves the quality of life and user satisfaction. The integration of insulin injection and CGM data facilitates both users and the healthcare team to analyse glucose control and implement appropriate therapeutic changes, reducing therapeutic inertia. This expert's recommendation reviews the characteristics of the devices marketed or in the process of being marketed and their available scientific evidence. Finally, it suggests the profile of users and professionals who would benefit most, the barriers to its generalisation and the changes in the care model that implementing these devices can bring with it.
Purpose Gestational weight gain (GWG) is an important contributor to pregnancy outcomes in the general obstetric population and different subgroups. The corresponding information in women with thyroid conditions is limited. We aimed to evaluate the relationship between GWG according to institute of medicine (IOM) and pregnancy outcomes in women with thyroid disorders. Methods We performed a retrospective analysis of 620 pregnant women either treated with levothyroxine ( N = 545) or attended because of hyperthyroidism during pregnancy ( N = 75). Results The associations between GWG according to IOM and pregnancy outcomes were present both in women treated with thyroid hormone and women followed by hyperthyroidism, most of them related to the fetal outcomes. In women treated with levothyroxine, insufficient GWG was associated with gestational diabetes mellitus (GDM) (odds ratio (OR) 2.32, 95% confidence interval (CI) 1.18, 4.54), preterm birth (OR 2.31, 95% CI 1.22, 4.36), small-for-gestational age newborns (OR 2.38, 95% CI 1.09, 5.22) and respiratory distress (OR 6.89, 95% CI 1.46, 32.52). Excessive GWG was associated with cesarean delivery (OR 1.66, 95% CI 1.10, 2.51) and macrosomia (OR 2.75, 95% CI 1.38, 5.49). Large-for-gestational age newborns were associated with both insufficient GWG (OR 0.25, 95% CI 0.11, 0.58) and excessive GWG (OR 1.80, 95% CI 1.11, 2.92). In women followed by hyperthyroidism, excessive GWG was associated with large-for-gestational age newborns (OR 5.56, 95% CI 1.03, 29.96). Conclusion GWG according to IOM is associated with pregnancy outcomes both in women treated with thyroid hormone and women followed by hyperthyroidism.
Technological advances in the management of diabetes, especially type 1 diabetes (T1D), have played a main role in significantly improving glycemic control of these patients in recent years. Undoubtedly, the most important advance has been the commercialization of hybrid closed-loop systems (HCL). Their effectiveness places them in the different guidelines from scientific societies as the gold standard for the treatment of people with T1D. However, obtaining the maximum performance from these systems requires a degree of expertise from the professionals who care for these patients. Specifically, the Tandem X2:slim with Control-IQ technology system, due to its features and configuration options and adjustments, allows T1D patients to better adapt the management of diabetes to multiple circumstances in their day-to-day life. It is necessary, however, to follow a systematic process to start the system and also for the subsequent follow-up, which allows its optimization in the shortest possible time. This expert recommendation reviews the main features of this HCL system, suggesting how to implement it and optimize its use after gaining experience treating many patients.
AimsWe aimed to explore the relationship between gestational weight gain (GWG) after Institute of Medicine (IOM) and pregnancy outcomes in women with type 1 and type 2 diabetes.MethodsRetrospective cohort study at a tertiary medical center (1981-2011). Outcome variables: 2 maternal and 14 fetal. Main exposure variable: GWG according to IOM. We calculated crude and adjusted ORs as well as population attributable (PAF) and preventable fractions (PPF) for significant positive and negative associations, respectively.ResultsWe evaluated 633 pregnant women with type 1 or type 2 diabetes. GWG was insufficient (iGWG) in 16.7% and excessive (eGWG) in 50.7%. In the adjusted analysis, GWG according to IOM was significantly associated with maternal outcomes (pregnancy-induced hypertension and cesarean delivery) and four fetal outcomes (large-for-gestational age, macrosomia, small-for-gestational age and neonatal respiratory distress). The association with large-for-gestational age newborns was negative for iGWG (0.48, CI 95% 0.25-0.94) and positive for eGWG (1.76, CI 95% 1.18-2.63). In addition, iGWG was associated with a higher risk of small-for-gestational age newborns and respiratory distress and eGWG with a higher risk of pregnancy-induced hypertension, caesarean delivery and macrosomia. PAF and PPF ranged from the 20.4% PPF of iGWG for large-for-gestational age to 56.5% PAF of eGWG for macrosomia.ConclusionIn this cohort of women with type 1 or type 2 diabetes, inadequate GWG after IOM was associated with adverse pregnancy outcomes; associations were unfavorable for eGWG and mixed for iGWG. The attributable fractions were not moderate, pointing to the potential impact of modifying inadequate GWG.
Background: Continuous glucose monitoring (CGM) systems are increasingly being adopted as an alternative or adjunct to self-monitoring of blood glucose (SMBG) by patients receiving insulin therapy. However, the available evidence on the role of intermittently scanned CGM or flash CGM (isCGM) remains limited. This consensus aims to evaluate the degree of agreement among Spanish experts on the role of isCGM in the evaluation of glycemic variability, reduction of glycosylated hemoglobin (HbA1c) levels, and selection and adjustment of insulin therapy. Methods: Delphi methodology was used to achieve consensus in two survey rounds. A total of 431 Spanish endocrinologists participated in the first round of a 34-item questionnaire survey on isCGM and 427 participated in the second round. Any disagreement was resolved in round 2. Results: Consensus was reached for 32 statements, and four items were ultimately agreed upon SMBG after round 2. There was a high degree of consensus that isCGM helps to evaluate glycemic variability, improves HbA1c levels, and can guide therapeutic changes in type 1 diabetes patients. However, there was no consensus on the routine use of the interquartile range to evaluate glycemic variability or the selection of HbA1c as the main parameter for monitoring glycemic control. Conclusions: Most Spanish experts believe that the isCGM system is appropriate for: (1) identifying glycemic variability and facilitating its management, (2) evaluating hyperglycemia as a complement of HbA1c levels, and (3) guiding therapeutic decisions on insulin selection and dosing. The isCGM system is a useful tool for patients and health care professionals to improve glycemic control in insulin-dependent diabetes.
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).