BACKGROUND: Diabetes mellitus (DM) is a chronic disease with prevalence increasing worldwide. The aim of this study was to investigate satisfaction with the current method of insulin delivery (INS) amongst patient with type 1 diabetes mellitus (T1DM) using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII). Furthermore, a sub-aim was to test the effect of selected variables on patient satisfaction with MDI or CSII using regression analysis. METHODS: A cross-sectional study carried out in the territory of Moravia in the Czech Republic. A quantitative approach using the Insulin Delivery System Rating Questionnaire (IDSRQ) among 197 respondents with T1DM with INS delivery with MDI or CSII for at least 1 year. Statistical methods used were descriptive statistics, Student's t-tests and regression analysis. RESULTS: Highly significant differences were found between CSII and MDI patients in satisfaction with the current method of INS delivery (p < 0.001), in how the current method of delivery helps patients maintain stable blood glucose values, prevent high blood glucose (p < 0.001), and in overall satisfaction with the current method of INS delivery (p < 0.001). The average overall satisfaction score was 56.19 points for MDI and 62.08 points for CSII. Regression analysis revealed predictors of overall satisfaction on the mean score on how the current method of INS delivery helps MDI patients (p < 0.01). The effect of other selected variables was not confirmed. CONCLUSION: The results of the study showed higher overall satisfaction with the method of INS delivery in CSII patients. The current method of INS delivery does not interfere with daily life and activities in most patients.
- Klíčová slova
- Continuous subcutaneous insulin infusion, Insulin delivery system rating questionnaire, Multiple daily injection, Regression analysis, Type 1 diabetes mellitus,
- MeSH
- diabetes mellitus 1. typu * farmakoterapie krev psychologie MeSH
- dospělí MeSH
- hypoglykemika * aplikace a dávkování terapeutické užití MeSH
- injekce subkutánní MeSH
- inzulin * aplikace a dávkování terapeutické užití MeSH
- inzulinové infuzní systémy * MeSH
- krevní glukóza MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- průřezové studie MeSH
- průzkumy a dotazníky MeSH
- spokojenost pacientů * MeSH
- subkutánní infuze MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Názvy látek
- hypoglykemika * MeSH
- inzulin * MeSH
- krevní glukóza MeSH
Automated insulin delivery systems (AID) represent a major advance in the treatment of type 1 diabetes. These systems automate insulin delivery by integrating continuous glucose monitoring, control algorithms and insulin pump actions. Despite their advances, there is a need to adjust the settings in specific situations, either by using special features or even by manually adjusting the dose. The article provides an overview of the possibilities of adjustments in the insulin dosing for intercurrent disease, alcohol consumption and increased physical activity for four certified automatic insulin delivery systems available in the Czech Republic.
- Klíčová slova
- type 1 diabetes, hypoglycaemia, continuous glucose monitoring, automated insulin delivery systems, intercurrent disease, alcohol consumption, physical activity,
- MeSH
- diabetes mellitus 1. typu * farmakoterapie MeSH
- hypoglykemika aplikace a dávkování MeSH
- inzulin * aplikace a dávkování MeSH
- inzulinové infuzní systémy * MeSH
- lidé MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Názvy látek
- hypoglykemika MeSH
- inzulin * MeSH
AIM: To compare open-source AndroidAPS (AAPS) and commercially available Control-IQ (CIQ) automated insulin delivery (AID) systems in a prospective, open-label, single-arm clinical trial. METHODS: Adults with type 1 diabetes who had been using AAPS by their own decision entered the first 3-month AAPS phase then were switched to CIQ for 3 months. The results of this treatment were compared with those after the 3-month AAPS phase. The primary endpoint was the change in time in range (% TIR; 70-80 mg/dL). RESULTS: Twenty-five people with diabetes (mean age 34.32 ± 11.07 years; HbA1c 6.4% ± 3%) participated in this study. CIQ was comparable with AAPS in achieving TIR (85.72% ± 7.64% vs. 84.24% ± 8.46%; P = .12). Similarly, there were no differences in percentage time above range (> 180 and > 250 mg/dL), mean sensor glucose (130.3 ± 13.9 vs. 128.3 ± 16.9 mg/dL; P = .21) or HbA1c (6.3% ± 2.1% vs. 6.4% ± 3.1%; P = .59). Percentage time below range (< 70 and < 54 mg/dL) was significantly lower using CIQ than AAPS. Even although participants were mostly satisfied with CIQ (63.6% mostly agreed, 9.1% strongly agreed), they did not plan to switch to CIQ. CONCLUSIONS: The CODIAC study is the first prospective study investigating the switch between open-source and commercially available AID systems. CIQ and AAPS were comparable in achieving TIR. However, hypoglycaemia was significantly lower with CIQ.
- Klíčová slova
- continuous glucose monitoring, glycaemic control, hypoglycaemia, insulin pump therapy, type 1 diabetes,
- MeSH
- diabetes mellitus 1. typu * farmakoterapie MeSH
- dospělí MeSH
- glykovaný hemoglobin MeSH
- hypoglykemika terapeutické užití MeSH
- inzulin terapeutické užití MeSH
- inzulinové infuzní systémy MeSH
- inzuliny * MeSH
- krevní glukóza MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- selfmonitoring glykemie metody MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- hypoglykemika MeSH
- inzulin MeSH
- inzuliny * MeSH
- krevní glukóza MeSH
OBJECTIVE: To compare parameters of glycemic control among three types of hybrid closed loop (HCL) systems in children with T1D (CwD) using population-wide data from the national pediatric diabetes registry ČENDA. METHODS: CwD aged <19 years treated with Medtronic MiniMed 780G (780G), Tandem t:slim X2 (Control-IQ) or do-it-yourself AndroidAPS (AAPS) systems for >12 months and monitored by CGM >70% of the time were included. HbA1c, times in glycemic ranges, and Glycemia Risk Index (GRI) were used for cross-sectional comparison between the HCL systems. RESULTS: Data from 512 CwD were analyzed. 780G, Control-IQ and AAPS were used by 217 (42.4%), 211 (41.2%), and 84 (16.4%) CwD, respectively. The lowest HbA1c value was observed in the AAPS group (44 mmol/mol; IQR 8.0, p<0.0001 vs any other group), followed by Control-IQ and 780G groups (48 (IQR 11) and 52 (IQR 10) mmol/mol, respectively). All of the systems met the recommended criteria for time in range (78% in AAPS, 76% in 780G, and 75% in Control-IQ users). CwD using AAPS spent significantly more time in hypoglycemia (5% vs 2% in 780G and 3% in Control-IQ) and scored the highest GRI (32, IQR 17). The lowest GRI (27, IQR 15) was seen in 780G users. CONCLUSION: Although all HCL systems proved effective in maintaining recommended long-term glycemic control, we observed differences that illustrate strengths and weaknesses of particular systems. Our findings could help in individualizing the choice of HCL systems.
- Klíčová slova
- AndroidAPS, hybrid closed loop, pediatrics, registry, type 1 diabetes,
- MeSH
- diabetes mellitus 1. typu * farmakoterapie MeSH
- dítě MeSH
- glykovaný hemoglobin MeSH
- hypoglykemie * chemicky indukované epidemiologie MeSH
- inzulin terapeutické užití MeSH
- inzulinové infuzní systémy MeSH
- krevní glukóza MeSH
- lidé MeSH
- průřezové studie MeSH
- registrace MeSH
- selfmonitoring glykemie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- inzulin MeSH
- krevní glukóza MeSH
BACKGROUND AND AIMS: The optimal basal and bolus insulin distribution in type 1 diabetes (T1D) is still controversial. Herein, we aimed to determine the variability of basal to total daily insulin dose according to treatment modality and diabetes technologies from the Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) registry. Methods. The study cohort was generated by using the SWEET database. Patients with T1D for at least 2 years, aged between 2.5 and 18 years, with at least one clinic visit between June 2010 and June 2021, were included in the study. Four groups were composed according to treatment modality as follows: multiple daily injections (MDI) without continuous glucose monitoring (CGM); MDI with CGM; subcutaneous insulin infusion (CSII) without CGM; and CSII with CGM. Data of the participants were analyzed and compared for each treatment modality separately. RESULTS: A total of 38,956 children and adolescents were included in the study. Of the study sample, 48.6% were female, the median (range) age was 15.2 (11.9-17.2) years, and the median diabetes duration was 6.0 (3.8-9.0) years. The distribution of treatment modality was as follows: MDI without CGM, 32.9%; MDI with CGM, 18.0%; CSII without CGM, 11.7%; and CSII with CGM, 37.3%. In unadjusted data, regardless of treatment modality, all the analyses revealed a significant association between basal dose to total daily insulin dose (BD/TDD) with male gender, younger age group, and lower HbA1c, which were all related to a decreased ratio of BD/TDD (all p < 0.05). There was no association between BD/TDD and different diabetes technologies after the age, gender, and diabetes duration were adjusted. CONCLUSIONS: Herein, we showed that there was an association between lower proportions of basal to total insulin and lower hemoglobin A1c in a large cross-sectional cohort of children who had T1D. There was also an association between lower BD/TDD and younger age. There was no significant difference between BD/TDD ratios under different diabetes technologies (CGM and/or CSII).
- MeSH
- diabetes mellitus 1. typu * farmakoterapie krev MeSH
- dítě MeSH
- glykovaný hemoglobin analýza MeSH
- hypoglykemika * aplikace a dávkování MeSH
- inzulin * aplikace a dávkování MeSH
- inzulinové infuzní systémy MeSH
- krevní glukóza analýza MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
- registrace MeSH
- selfmonitoring glykemie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- hypoglykemika * MeSH
- inzulin * MeSH
- krevní glukóza MeSH
Objective: We evaluated the safety and feasibility of open-source automated insulin delivery AndroidAPS in adolescents and young adults with type 1 diabetes (T1D) and compared its efficacy in three different scenarios: hybrid closed loop (HCL) with meal boluses, meal announcement only (MA), and full closed loop (FCL). Research Design and Methods: In an open-label, prospective, randomized crossover trial (clinicaltrials.gov NCT04835350), 16 adolescents with T1D (10 females) with mean age of 17 years (range 15-20), glycated hemoglobin 56 mmol/mol (range 43-75), and mean duration of diabetes 5.9 years (9-15) underwent three distinct 3-day periods of camp living, comparing the above-mentioned scenarios of AndroidAPS. We used modified and locked version of AndroidAPS 3.1.03, which was called Pancreas4ALL for study purposes. The order of MA and FCL periods was assigned randomly. The primary endpoints were feasibility and safety of the system represented by percentage of time of glucose control by the system and time in hypoglycemia below 3 mmol/L. Results: The glycemia was controlled by the system 95% time of the study and the proportion of time below 3 mmol/L did not exceed 1% over the whole study period (0.72%). The HCL scenario reached significantly higher percentage of time below 3 mmol/L (HCL 1.05% vs. MA 0.0% vs. FCL 0.0%; P = 0.05) compared to other scenarios. No difference was observed among the scenarios in the percentage of time between 3.9 and 10 mmol/L (HCL 83.3% vs. MA 79.85% vs. FCL 81.03%, P = 0.58) corresponding to mean glycemia (HCL 6.65 mmol/L vs. MA 7.34 mmol/L vs. FCL 7.05 mmol/L, P = 0.28). No difference was observed in the mean daily dose of insulin or in the daily carbohydrate intake. No serious adverse event occurred during the study period. Conclusions: Our pilot study showed that FCL might be a realistic mode of treatment for people with T1D.
- Klíčová slova
- Automated insulin delivery, Do-it-yourself systems, Full closed loop, Hybrid closed loop, Open source, Pancreas4ALL,
- MeSH
- diabetes mellitus 1. typu * farmakoterapie MeSH
- dospělí MeSH
- hypoglykemika MeSH
- inzulin lidský terapeutické užití MeSH
- inzulin * terapeutické užití MeSH
- inzulinové infuzní systémy MeSH
- klinické křížové studie MeSH
- krevní glukóza MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- pilotní projekty MeSH
- prospektivní studie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- hypoglykemika MeSH
- inzulin lidský MeSH
- inzulin * MeSH
- krevní glukóza MeSH
Diabetes is a heterogeneous group of diseases that share a common trait of elevated blood glucose levels. Insulin lowers this level by promoting glucose utilization, thus avoiding short- and long-term organ damage due to the elevated blood glucose level. A patient with diabetes uses an insulin pump to dose insulin. The pump uses a controller to compute and dose the correct amount of insulin to keep blood glucose levels in a safe range. Insulin-pump controller development is an ongoing process aiming at fully closed-loop control. Controllers entering the market must be evaluated for safety. We propose an evaluation method that exploits an FDA-approved diabetic patient simulator. The method evaluates a Cartesian product of individual insulin-pump parameters with a fine degree of granularity. As this is a computationally intensive task, the simulator executes on a distributed cluster. We identify safe and risky combinations of insulin-pump parameter settings by applying the binomial model and decision tree to this product. As a result, we obtain a tool for insulin-pump settings and controller safety assessment. In this paper, we demonstrate the tool with the Low-Glucose Suspend and OpenAPS controllers. For average ± standard deviation, LGS and OpenAPS exhibited 1.7 ± 0.6% and 3.2 ± 1.8% of local extrema (i.e., good insulin-pump settings) out of all the entire Cartesian products, respectively. A continuous region around the best-discovered settings (i.e., the global extremum) of the insulin-pump settings spread across 4.0 ± 1.1% and 4.1 ± 1.3% of the Cartesian products, respectively.
- Klíčová slova
- controller, diabetes, in silico, insulin pump, smartcgms,
- MeSH
- diabetes mellitus 1. typu * MeSH
- hypoglykemika terapeutické užití MeSH
- inzulin terapeutické užití MeSH
- inzulinové infuzní systémy MeSH
- krevní glukóza * MeSH
- lidé MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- hypoglykemika MeSH
- inzulin MeSH
- krevní glukóza * MeSH
Patient with diabetes must regularly monitor blood glucose level. Drawing a blood sample is a painful and discomfort experience. Alternatively, the patient measures interstitial fluid glucose level with a sensor installed in subcutaneous tissue. Then, a model of glucose dynamics calculates blood glucose level from the sensor-measured, i.e., interstitial fluid glucose level of subcutaneous tissue. Interstitial fluid glucose level can significantly differ from blood glucose level. The sensor is either factory-calibrated, or the patient calibrates the sensor periodically by drawing blood samples, when glucose levels of both compartments are steady. In both cases, the sensor lifetime is limited up to 14 days. This is the present state of the art. With a physiological model, we would like to prolong the sensor lifetime with an adaptive approach, while requiring no additional blood sample. Prolonging sensor's lifetime, while reducing the associated discomfort, would considerably improve patient's quality of life. We demonstrate that it is possible to determine personalized model parameters from multiple CGMS-signals only, using an animal experiment with a hyperglycemic clamp. The experimenter injected separate glucose and insulin boluses to trigger rapid changes, on which we evaluated the ability to react to non-steady glucose levels in different compartments. With the proposed model, 70%, 80% and 95% of the calculated blood glucose levels had relative error less than or equal to 21.9%, 32.5% and 43.6% respectively. Without the model, accuracy of the sensor-estimated blood glucose level decreased to 39.4%, 49.9% and 99.0% relative errors. This confirms feasibility of the proposed method.
- MeSH
- glukosa MeSH
- inzulin MeSH
- inzulinové infuzní systémy MeSH
- krevní glukóza * MeSH
- kvalita života * MeSH
- lidé MeSH
- selfmonitoring glykemie metody MeSH
- zvířata MeSH
- Check Tag
- lidé MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- glukosa MeSH
- inzulin MeSH
- krevní glukóza * MeSH
AIMS: To compare insulin dose adjustments made by physicians to those made by an artificial intelligence-based decision support system, the Advisor Pro, in people with type 1 diabetes (T1D) using an insulin pump and self-monitoring blood glucose (SMBG). METHODS: This was a multinational, non-interventional study surveying 17 physicians from 11 countries. Each physician was asked to provide insulin dose adjustments for the settings of the pump including basal rate, carbohydrate-to-insulin ratios (CRs), and correction factors (CFs) for 15 data sets of pumps and SMBG of people with T1D (mean age 18.4 ± 4.8 years; eight females; mean glycated hemoglobin 8.2% ± 1.4% [66 ± 11mmol/mol]). The recommendations were compared among the physicians and between the physicians and the Advisor Pro. The study endpoint was the percentage of comparison points for which there was an agreement on the direction of insulin dose adjustments. RESULTS: The percentage (mean ± SD) of agreement among the physicians on the direction of insulin pump dose adjustments was 51.8% ± 9.2%, 54.2% ± 6.4%, and 49.8% ± 11.6% for the basal, CR, and CF, respectively. The automated recommendations of the Advisor Pro on the direction of insulin dose adjustments were comparable )49.5% ± 6.4%, 55.3% ± 8.7%, and 47.6% ± 14.4% for the basal rate, CR, and CF, respectively( and noninferior to those provided by physicians. The mean absolute difference in magnitude of change between physicians was 17.1% ± 13.1%, 14.6% ± 8.4%, and 23.9% ± 18.6% for the basal, CR, and CF, respectively, and comparable to the Advisor Pro 11.7% ± 9.7%, 10.1% ± 4.5%, and 25.5% ± 19.5%, respectively, significant for basal and CR. CONCLUSIONS: Considerable differences in the recommendations for changes in insulin dosing were observed among physicians. Since automated recommendations by the Advisor Pro were similar to those given by physicians, it could be considered a useful tool to manage T1D.
- Klíčová slova
- Advisor Pro *, automated decision support *, insulin pump settings adjustments *, self-monitoring of blood glucose *, type 1 diabetes *,
- MeSH
- diabetes mellitus 1. typu * farmakoterapie MeSH
- dospělí MeSH
- glykovaný hemoglobin analýza MeSH
- hypoglykemika MeSH
- inzulin MeSH
- inzulinové infuzní systémy MeSH
- krevní glukóza MeSH
- lékaři * MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- selfmonitoring glykemie MeSH
- umělá inteligence MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- hypoglykemika MeSH
- inzulin MeSH
- krevní glukóza MeSH
Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.
- MeSH
- diabetes mellitus 1. typu * farmakoterapie MeSH
- hypoglykemika terapeutické užití MeSH
- inzulin * terapeutické užití MeSH
- inzulinové infuzní systémy MeSH
- lidé MeSH
- zdravotnický personál MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
- Research Support, N.I.H., Extramural MeSH
- Názvy látek
- hypoglykemika MeSH
- inzulin * MeSH