Hybrid closed-loop
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Impaired awareness of hypoglycemia remains an issue even in the era of modern technologies, as patients with type 1 diabetes (T1DM) face stricter requirements for glycemic targets. The evaluation of hypoglycemia awareness can be accomplished using questionnaires (Clarke and Gold scores) in combination with clinical appearance and sensor data. A 45-year-old man with T1DM was referred to our clinic in July 2019 due to impaired hypoglycemia awareness and repeated severe hypoglycemic episodes resulting in unconsciousness. At that time, he was driving both a car and a motorcycle. Despite good compliance, increased target values and implementation of continuous glucose monitoring (CGM) with alarms, prolonged hypoglycemias were not eliminated. Therefore, the patient was referred for pancreatic islet transplantation, but he decided not to undergo. In May 2021, his driving license was suspended, which eventually led him to accept treatment with a hybrid closed-loop insulin pump (AID). Shortly after initiation, he achieved satisfactory glycemic control, reduced time spent in hypoglycemia, and had no severe hypoglycemic episodes. According to the questionnaires, the hypoglycemia awareness has improved and his driving license was reinstated. This case study highlights the critical importance of identifying impaired awareness of hypoglycemia, its potential social impacts, and the opportunities for using new technologies to reverse this complication.
- Klíčová slova
- case report, diabetes type 1, hybrid closed-loop insulin pump, hypoglycemia, hypoglycemia unawareness syndrome,
- Publikační typ
- časopisecké články MeSH
- kazuistiky MeSH
In both pediatric and adult populations with type 1 diabetes (T1D), technologies such as continuous subcutaneous insulin infusion (CSII), continuous glucose monitoring (CGM), or sensor-augmented pumps (SAP) can consistently improve glycemic control [measured as glycated hemoglobin (HbA1c) and time in range (TIR)] while reducing the risk of hypoglycemia. Use of technologies can thereby improve quality of life and reduce the burden of diabetes management compared with self-injection of multiple daily insulin doses (MDI). Novel hybrid closed-loop (HCL) systems represent the latest treatment modality for T1D, combining modern glucose sensors and insulin pumps with a linked control algorithm to offer automated insulin delivery in response to blood glucose levels and trends. HCL systems have been associated with increased TIR, improved HbA1c, and fewer hypoglycemic events compared with CSII, SAP, and MDI, thereby potentially improving quality of life for people with diabetes (PwD) while reducing the costs of treating short- and long-term diabetes-related complications. However, many barriers to their use and regional inequalities remain in Central and Eastern Europe (CEE). Published data suggest that access to diabetes technologies is hindered by lack of funding, underdeveloped health technology assessment (HTA) bodies and guidelines, unfamiliarity with novel therapies, and inadequacies in healthcare system capacities. To optimize the use of diabetes technologies in CEE, an international meeting comprising experts in the field of diabetes was held to map the current regional access, to present the current national reimbursement guidelines, and to recommend solutions to overcome uptake barriers. Recommendations included regional and national development of HTA bodies, efficient allocation of resources, and structured education programs for healthcare professionals and PwD. The responsibility of the healthcare community to ensure that all individuals with T1D gain access to modern technologies in a timely and economically responsible manner, thereby improving health outcomes, was emphasized, particularly for interventions that are cost-effective.
- Klíčová slova
- Advanced hybrid closed-loop, Central and Eastern Europe, Hybrid closed-loop, Position statement, Type 1 diabetes,
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: Officially licensed hybrid closed-loop systems are not currently available worldwide; therefore, open-source systems have become increasingly popular. Our aim was to assess the safety, feasibility, and efficacy of an open-source hybrid closed-loop system (AndroidAPS) versus SmartGuard® technology for day-and-night glucose control in children under extreme sports conditions. RESEARCH DESIGN AND METHODS: Twenty-two children (16 girls, 6-15 years of age, median HbA1c 56 ± 9 mmol/mol) were enrolled in this pivotal winter sports camp study. The participants were divided into two groups using either the AndroidAPS or SmartGuard technology. Physical exertion was represented by all-day alpine skiing. The primary endpoints were mean glucose level, time below the threshold of 3.9 mmol/L, and time within the target range of 3.9 to 10 mmol/L. RESULTS: The children using the AndroidAPS had significantly lower mean glycemia levels (7.2 ± 2.7 vs. 7.7 ± 2.8 mmol/L; 129.6 ± 49 vs. 138.6 ± 50 mg/dL, P < 0.042) than the children using the SmartGuard. The proportion of time below the target (median 5.0% ± 2.5% vs. 3.0% ± 2.3%, P = 0.6) and in the target zone (63% ± 9.5% vs. 63% ± 18%, P = 0.5) did not significantly differ. The AndroidAPS group experienced more frequent malfunctions of the cannula set (median 0.8 ± 0.4 vs. 0.2 ± 0.4, P = 0.02), which could have affected the results. No significant difference was found in the amount of carbohydrates consumed for the prevention and treatment of hypoglycemia [median 40 ± 23 vs. 25 ± 29 g/(patient ·3 days)]. No episodes of severe hypoglycemia or other serious adverse events were noted. CONCLUSIONS: This pilot study showed that the AndroidAPS system was a safe and feasible alternative to the SmartGuard Technology.
- Klíčová slova
- AndroidAPS, Do-it-yourself systems., Open-source hybrid closed loop,
- MeSH
- cvičení fyziologie MeSH
- diabetes mellitus 1. typu krev farmakoterapie patofyziologie MeSH
- dítě MeSH
- glykovaný hemoglobin metabolismus MeSH
- hypoglykemie etiologie prevence a kontrola MeSH
- hypoglykemika aplikace a dávkování MeSH
- inzulin aplikace a dávkování MeSH
- inzulinové infuzní systémy * MeSH
- krevní glukóza metabolismus MeSH
- lidé MeSH
- lyžování fyziologie MeSH
- mladiství MeSH
- pilotní projekty MeSH
- selfmonitoring glykemie přístrojové vybavení metody MeSH
- studie proveditelnosti MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnotící studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- hemoglobin A1c protein, human MeSH Prohlížeč
- hypoglykemika MeSH
- inzulin MeSH
- krevní glukóza MeSH
OBJECTIVE: Data on closed loop systems in young children with type 1 diabetes (T1D) are limited. We tested the efficacy and safety of an open-source, do-it-yourself automated insulin delivery system AndroidAPS in preschool and school-aged children. RESEARCH DESIGN AND METHODS: This retrospective study analyzed diabetes control in 18 preschool (3-7 years) and 18 school-aged children (8-14 years) with T1D who switched from a sensor-augmented pump (SAP) to AndroidAPS. We compared the CGM parameters and HbA1c levels 3 months before and 6 months after the initiation of AndroidAPS therapy and evaluated frequency of severe adverse events during AndroidAPS use, the most frequent reasons for its interruption, and the experience and psychosocial benefits of AndroidAPS use. RESULTS: General glycemic control was significantly improved after the switch from SAP to AndroidAPS. Time in range (TIR) increased in both preschool (70.8%-78.6%, p = 0.004) and school-aged children (77.2%-82.9%, p < 0.001), whereas HbA1c levels decreased (preschool children 53.8-48.5 mmol/mol, p < 0.001; school-aged children 52.6-45.1 mmol/mol, p = 0.001). Time spent in range of 3.0-3.8 mmol/L increased slightly in school children (2.6%-3.8%, p = 0.040), but not in preschool children (3.0%-3.0%, p = 0.913). Time spent at <3 mmol/L remained unchanged in both preschool (0.95%-0.67%, p = 0.432) and school-aged children (0.8%-0.8%, p = 1.000). No episodes of severe hypoglycemia or DKA and significant improvement of quality of life were reported by AndroidAPS users. CONCLUSIONS: AndroidAPS seems effective for T1D control both in preschool and school-age children but further validation by prospective studies is necessary.
- Klíčová slova
- AndroidAPS, do it yourself systems, open source hybrid closed loop, young children,
- MeSH
- časové faktory MeSH
- diabetes mellitus 1. typu krev farmakoterapie MeSH
- dítě MeSH
- glykovaný hemoglobin metabolismus MeSH
- hypoglykemika aplikace a dávkování MeSH
- inzulin aplikace a dávkování MeSH
- inzulinové infuzní systémy * MeSH
- krevní glukóza metabolismus MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
- retrospektivní studie MeSH
- selfmonitoring glykemie * MeSH
- věkové faktory MeSH
- výsledek terapie 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
- hemoglobin A1c protein, human MeSH Prohlížeč
- 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
INTRODUCTION: The aim of the study was to assess the differences in key parameters of type 1 diabetes (T1D) control associated with treatment and monitoring modalities including newly introduced hybrid closed-loop (HCL) algorithm in children and adolescents with T1D (CwD) using the data from the population-wide pediatric diabetes registry ČENDA. METHODS: CwD younger than 19 years with T1D duration >1 year were included and divided according to the treatment modality and type of CGM used: multiple daily injection (MDI), insulin pump without (CSII) and with HCL function, intermittently scanned continuous glucose monitoring (isCGM), real-time CGM (rtCGM), and intermittent or no CGM (noCGM). HbA1c, times in glycemic ranges, and glucose risk index (GRI) were compared between the groups. RESULTS: Data of a total of 3,251 children (mean age 13.4 ± 3.8 years) were analyzed. 2,187 (67.3%) were treated with MDI, 1,064 (32.7%) with insulin pump, 585/1,064 (55%) with HCL. The HCL users achieved the highest median TIR 75.4% (IQR 6.3) and lowest GRI 29.1 (7.8), both p < 0.001 compared to other groups, followed by MDI rtCGM and CSII groups with TIR 68.8% (IQR 9.0) and 69.0% (7.5), GRI 38.8 (12.5) and 40.1 (8.5), respectively (nonsignificant to each other). These three groups did not significantly differ in their HbA1c medians (51.8 [IQR 4.5], 50.7 [4.5], and 52.7 [5.7] mmol/mol, respectively). NoCGM groups had the highest HbA1c and GRI and lowest TIR regardless of the treatment modality. CONCLUSION: This population-based study shows that the HCL technology is superior to other treatment modalities in CGM-derived parameters and should be considered as a treatment of choice in all CwD fulfilling the indication criteria.
- Klíčová slova
- Children, Hybrid closed loop, Registry, Type 1 diabetes,
- MeSH
- diabetes mellitus 1. typu * farmakoterapie MeSH
- dítě MeSH
- glykovaný hemoglobin MeSH
- hypoglykemika terapeutické užití MeSH
- inzulin terapeutické užití MeSH
- krevní glukóza MeSH
- lidé MeSH
- mladiství MeSH
- regulace glykemie MeSH
- selfmonitoring glykemie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- glykovaný hemoglobin MeSH
- hypoglykemika MeSH
- inzulin 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
A thermodynamic model is proposed describing swelling changes and swelling transitions of hybrid gels in which domains of folded chains are chemically built in as cross-links. These folded domains can be unfolded to random coils by osmotic forces produced by the synthetic gel matrix. Uncoiling takes place if the osmotic force acting on the cross-links exceeds the critical value. By unfolding, a new interacting surface is exposed to interactions and affects the swelling pressure. The chains of the folded domains may have ionized groups. The model is based on mean-field statistical-thermodynamic treatment of swelling of polyelectrolyte gels with finite extensibility of network chains. This study is related to hybrid hydrogels with built in protein motifs. A continuous change in external variables increasing the degree of swelling of the hydrogel brings about an abrupt increase in volume (transition) of the gel. The position and magnitude of the transition depend on structural parameters of the hybrid gel, such as fraction of the folded domains in the gel, degree of ionization of chains in the domain, presence of additional chemical cross-links, or degree of dilution at gel formation. Two options for reversibility of the changes are considered: (a) unfolding is irreversible and deswelling proceeds along other curve than swelling and (b) swelling is reversible when the osmotic force decrease below the critical value. In the latter case, swelling changes are described by a closed loop with two transitions. Under certain conditions (high dilution at network formation and sufficiently high degree of ionization of chains of the folded domains), a transition appears known as the collapse transition induced by balance of hydrophobic and hydrophillic interactions. This collapse transition induces the folding transition by which the folded domains are reformed.
- MeSH
- absorpce MeSH
- biopolymery chemie MeSH
- gely MeSH
- molekulární struktura MeSH
- polymery chemie MeSH
- reagencia zkříženě vázaná chemie MeSH
- termodynamika MeSH
- tlak MeSH
- voda MeSH
- změna skupenství * MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- biopolymery MeSH
- gely MeSH
- polymery MeSH
- reagencia zkříženě vázaná MeSH
- voda MeSH
High-level amplifications of MYC genes are associated with poor outcomes in childhood medulloblastoma (MB). However, the occurrence of MYCN and MYCC copy number increases below the intense amplification pattern is rarely reported, and its clinical impact has not yet been determined. Here, we describe this phenomenon and its prognostic significance in a cohort of 29 MB patients. Using interphase fluorescence in situ hybridization (I-FISH), low-level copy number alterations, i.e. gain of MYCN, were shown in 5/27 (19%) samples, whereas amplification was revealed in only 1/27 (4%) samples. MYCC gain was revealed in 6/29 (21%) MB, while amplification was disclosed in only 2/29 (7%). Hyperploidy and co-incidence of gains in both MYC loci were frequently observed in samples with copy number aberrations. Survival analysis has clearly shown that MYC copy number increases are associated with lowered event-free survival and overall survival in MB. In the case of MYCN, this negative correlation was statistically significant. We conclude that limited numerical alterations in loci 2p24 (MYCN) and 8q24 (MYCC), as assessed by I-FISH, are present in MB with a higher frequency than high-level amplifications. Poor prognoses were observed in patients with copy number increases in MYC genes. Our data illustrate the importance of further investigations in multicenter trials to better refine the emerging genomic-based prognostic stratification in MB.
- MeSH
- amplifikace genu * MeSH
- dítě MeSH
- genová dávka * MeSH
- hybridizace in situ fluorescenční MeSH
- interfáze MeSH
- jaderné proteiny genetika MeSH
- kohortové studie MeSH
- lidé MeSH
- meduloblastom genetika MeSH
- míra přežití MeSH
- mladiství MeSH
- nádory mozečku genetika MeSH
- onkogenní proteiny genetika MeSH
- předškolní dítě MeSH
- prognóza MeSH
- prospektivní studie MeSH
- protoonkogen n-myc MeSH
- protoonkogenní proteiny c-myc genetika MeSH
- retrospektivní studie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- jaderné proteiny MeSH
- MYC protein, human MeSH Prohlížeč
- MYCN protein, human MeSH Prohlížeč
- onkogenní proteiny MeSH
- protoonkogen n-myc MeSH
- protoonkogenní proteiny c-myc MeSH
INTRODUCTION: NOTES (Natural Orifice Transluminal Endoscopic Surgery) technique was developed to achieve less invasive surgery with the aim to lower frequency of postoperative complications. Cholecystectomy is one of the most frequent elective surgical procedures and is relevant for evaluation of NOTES. The aim of the experimental study was to compare hybrid transrectal and laparoscopic cholecystectomy regarding feasibility and inflammatory response. MATERIAL AND METHODS: A total of 20 pigs weighing 26-56 kg were randomized to laparoscopic or NOTES group. Transrectal approach (15-18 cm from anal edge) was created by needle knife, followed by balloon dilatation and two-channel endoscope was introduced into the abdominal cavity. Cystic artery and duct were clipped and dissected. After extirpation of the gall bladder the colostomy was closed by occlusion loop-and-clip (King' closure) technique. In the laparoscopic group, cholecystectomy was performed by three-port access. Blood samples for evaluation of inflammatory response markers (leukocytes, CRP, interleukin 6) were taken 0, 2nd, 7th and 30th postoperative day, when the experiment ended and pig was euthanized. RESULTS: Two pigs were excluded (1 died early postoperatively for pneumonia, 1 for the rectal closure impossibility after it's laceration during of the gall bladder extirpation). Other pigs survived without complications. Procedure time was significantly longer in NOTES group (134 +/- 27 minutes versus 60 +/- 22 minutes, p < 0.05). White blood cells count and CRP level increased significantly in both groups 2nd and 7th postoperative day and then normalized. Differences between groups were not significant in any of the measured laboratory markers. Sectional finding of exudate and adhesions was comparable in both groups and all transrectal closures were healed. Small subhepatal abscess was found in one pig from NOTES group. CONCLUSION: Transrectal hybrid cholecystectomy is a safe and feasible method with comparable inflammatory responses and longer operating time compared to laparoscopy. A novel loop-and-clip technique was verified as a safe and simple rectal closure.
- MeSH
- cholecystektomie laparoskopická metody MeSH
- endoskopické operace přirozenými otvory * MeSH
- Sus scrofa MeSH
- zvířata MeSH
- Check Tag
- zvířata MeSH
- Publikační typ
- anglický abstrakt MeSH
- časopisecké články MeSH