المؤلفون: Cardona-Hernandez, Roque, Dôvc, Klemen, Biester, Torben, Macedoni, Maddalena, Tauschmann, Martin, Mameli, Chiara, Ekhlaspour, Laya

مصطلحات موضوعية: Automated insulin delivery, Children, Technology, Time in range, Type 1 diabetes, Youths, Young Adult, Humans, Adolescent, Child, Adult, Diabetes Mellitus, Type 1, Hypoglycemic Agents, Glycemic Control, Blood Glucose Self-Monitoring, Blood Glucose, Insulin, Insulin Infusion Systems

الوصف: Type 1 diabetes (T1D) is the most frequent form of diabetes in pediatric age, affecting more than 1.5 million people younger than age 20 years worldwide. Early and intensive control of diabetes provides continued protection against both microvascular and macrovascular complications, enhances growth, and ensures normal pubertal development. In the absence of definitive reversal therapy for this disease, achieving and maintaining the recommended glycemic targets is crucial. In the last 30 years, enormous progress has been made using technology to better treat T1D. In spite of this progress, the majority of children, adolescents and young adults do not reach the recommended targets for glycemic control and assume a considerable burden each day. The development of promising new therapeutic advances, such as more physiologic insulin analogues, pioneering diabetes technology including continuous glucose monitoring and closed loop systems as well as new adjuvant drugs, anticipate a new paradigm in T1D management over the next few years. This review presents insights into current management of T1D in youths.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/7s31w37tTest

المؤلفون: Alwan, Heba, Ware, Julia, Boughton, Charlotte K, Wilinska, Malgorzata E, Allen, Janet M, Lakshman, Rama, Nwokolo, Munachiso, Hartnell, Sara, Bally, Lia, de Beaufort, Carine, Besser, Rachel EJ, Campbell, Fiona M, Davis, Nikki, Denvir, Louise, Evans, Mark L, Fröhlich-Reiterer, Elke, Ghatak, Atrayee, Hofer, Sabine E, Kapellen, Thomas M, Leelarathna, Lalantha, Mader, Julia K, Narendran, Parth, Rami-Mehrar, Birgit, Tauschmann, Martin, Thabit, Hood, Thankamony, Ajay, Hovorka, Roman

مصطلحات موضوعية: Artificial pancreas, Closed-loop insulin delivery, Insulin pump therapy, Randomized trial, Type 1 diabetes, Adolescent, Aged, Child, Preschool, Humans, Blood Glucose, Cross-Over Studies, Diabetes Mellitus, Type 1, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Regular, Human, Retrospective Studies, Treatment Outcome, Young Adult, Adult, Middle Aged

الوصف: Objective: We aimed to assess whether percentage of time spent in hypoglycemia during closed-loop insulin delivery differs by age group and time of day. Methods: We retrospectively analyzed data from hybrid closed-loop studies involving young children (2-7 years), children and adolescents (8-18 years), adults (19-59 years), and older adults (≥60 years) with type 1 diabetes. Main outcome was time spent in hypoglycemia <3.9 mmol/L (<70 mg/dL). Eight weeks of data for 88 participants were analyzed. Results: Median time spent in hypoglycemia over the 24-h period was highest in children and adolescents (4.4% [interquartile range 2.4-5.0]) and very young children (4.0% [3.4-5.2]), followed by adults (2.7% [1.7-4.0]), and older adults (1.8% [1.2-2.2]); P < 0.001 for difference between age groups. Time spent in hypoglycemia during nighttime (midnight-05:59) was lower than during daytime (06:00-23:59) across all age groups. Conclusion: Time in hypoglycemia was highest in the pediatric age group during closed-loop insulin delivery. Hypoglycemia burden was lowest overnight across all age groups.

وصف الملف: application/msword

العلاقة: https://www.repository.cam.ac.uk/handle/1810/350613Test; https://doi.org/10.17863/CAM.97045Test

الإتاحة: https://doi.org/10.17863/CAM.97045Test
https://www.repository.cam.ac.uk/handle/1810/350613Test

المؤلفون: Hood, Korey K., Garcia-Willingham, Natasha, Hanes, Sarah, Tanenbaum, Molly L., Ware, Julia, Boughton, Charlotte K., Allen, Janet M., Wilinska, Malgorzata E., Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona, Wadwa, R. Paul, Buckingham, Bruce A., Davis, Nikki, DiMeglio, Linda A., Mauras, Nelly, Besser, Rachel E. J., Ghatak, Atrayee, Weinzimer, Stuart A., Fox, D. Steven, Kanapka, Lauren, Kollman, Craig, Sibayan, Judy, Beck, Roy W., Hovorka, Roman

المساهمون: DAN05 Consortium

المصدر: PMC

مصطلحات موضوعية: Blood glucose, Blood glucose self-monitoring, Type 1 diabetes mellitus, Hypoglycemic agents, Insulin, Treatment outcome

الوصف: Aim: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. Materials and methods: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. Results: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants. Conclusions: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

وصف الملف: application/pdf

العلاقة: Diabetes, Obesity & Metabolism; Hood KK, Garcia-Willingham N, Hanes S, et al. Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents. Diabetes Obes Metab. 2022;24(12):2309-2318. doi:10.1111/dom.14815; https://hdl.handle.net/1805/36549Test

الإتاحة: https://doi.org/10.1111/dom.14815Test
https://hdl.handle.net/1805/36549Test

المؤلفون: Hood, Korey K, Garcia-Willingham, Natasha, Hanes, Sarah, Tanenbaum, Molly L, Ware, Julia, Boughton, Charlotte K, Allen, Janet M, Wilinska, Malgorzata E, Tauschmann, Martin, Denvir, Louise, Thankamony, Ajay, Campbell, Fiona, Wadwa, R Paul, Buckingham, Bruce A, Davis, Nikki, DiMeglio, Linda A, Mauras, Nelly, Besser, Rachel EJ, Ghatak, Atrayee, Weinzimer, Stuart A, Fox, D Steven, Kanapka, Lauren, Kollman, Craig, Sibayan, Judy, Beck, Roy W, Hovorka, Roman, DAN05 Consortium

المساهمون: Hood, Korey K [0000-0001-5730-7749], Boughton, Charlotte K [0000-0003-3272-9544], Apollo - University of Cambridge Repository

مصطلحات موضوعية: Blood Glucose, Parents, Diabetes Mellitus, Type 1, Treatment Outcome, Insulin Infusion Systems, Adolescent, Blood Glucose Self-Monitoring, Quality of Life, Humans, Insulin, Hypoglycemic Agents, Child

الوصف: AIM: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. MATERIALS AND METHODS: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. RESULTS: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants. CONCLUSIONS: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

وصف الملف: application/pdf; text/xml

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c33d752d25f167dc45d9af12213c2d09Test

المؤلفون: Bally, Lia, Thabit, Hood, Kojzar, Harald, Mader, Julia K, Qerimi-Hyseni, Jehona, Hartnell, Sara, Tauschmann, Martin, Allen, Janet M, Wilinska, Malgorzata E, Pieber, Thomas R, Evans, Mark L, Hovorka, Roman

مصطلحات موضوعية: Adult, Cross-Over Studies, Diabetes Mellitus, Type 1, Female, Humans, Hypoglycemia, Hypoglycemic Agents, Infusion Pumps, Implantable, Insulin, Insulin Infusion Systems, Male, Middle Aged, Time Factors, Treatment Outcome

الوصف: BACKGROUND: Tight control of blood glucose concentration in people with type 1 diabetes predisposes to hypoglycaemia. We aimed to investigate whether day-and-night hybrid closed-loop insulin delivery can improve glucose control while alleviating the risk of hypoglycaemia in adults with HbA1c below 7·5% (58 mmol/mol). METHODS: In this open-label, randomised, crossover study, we recruited adults (aged ≥18 years) with type 1 diabetes and HbA1c below 7·5% from Addenbrooke's Hospital (Cambridge, UK) and Medical University of Graz (Graz, Austria). After a 2-4 week run-in period, participants were randomly assigned (1:1), using web-based randomly permuted blocks of four, to receive insulin via the day-and-night hybrid closed-loop system or usual pump therapy for 4 weeks, followed by a 2-4 week washout period and then the other intervention for 4 weeks. Treatment interventions were unsupervised and done under free-living conditions. During the closed-loop period, a model-predictive control algorithm directed insulin delivery, and prandial insulin delivery was calculated with a standard bolus wizard. The primary outcome was the proportion of time when sensor glucose concentration was in target range (3·9-10·0 mmol/L) over the 4 week study period. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT02727231, and is completed. FINDINGS: Between March 21 and June 24, 2016, we recruited 31 participants, of whom 29 were randomised. One participant withdrew during the first closed-loop period because of dissatisfaction with study devices and glucose control. The proportion of time when sensor glucose concentration was in target range was 10·5 percentage points higher (95% CI 7·6-13·4; p<0·0001) during closed-loop delivery compared with usual pump therapy (65·6% [SD 8·1] when participants used usual pump therapy vs 76·2% [6·4] when they used closed-loop). Compared with usual pump therapy, closed-loop delivery also reduced the proportion of time spent in hypoglycaemia: the ...

وصف الملف: Print-Electronic; application/pdf

العلاقة: https://www.repository.cam.ac.uk/handle/1810/266506Test

الإتاحة: https://doi.org/10.17863/CAM.12094Test
https://www.repository.cam.ac.uk/handle/1810/266506Test

المؤلفون: Tauschmann, Martin, Schwandt, Anke, von Sengbusch, Simone, Holl, Reinhard W., Prinz, Nicole, Becker, Marianne, Biester, Torben, Hess, Melanie, Holder, Martin, Karges, Beate Maria, Näke, Andrea, Kuss, Oliver

المصدر: Pediatric diabetes 23(3), 330-340 (2022). doi:10.1111/pedi.13320

مصطلحات موضوعية: Glycated Hemoglobin, Male, Adolescent, Endocrinology, Diabetes and Metabolism, nutritional and metabolic diseases, Body Mass Index, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Pediatrics, Perinatology and Child Health, Internal Medicine, Humans, Hypoglycemic Agents, Insulin, Female, BMI, CSII, DPV, GBMT, TDD, children and adolescents with type 1 diabetes, diabetes, insulin pump, longitudinal patterns, multi trajectory modeling, trajectories of HbA1c, type 1 diabetes

الوصف: Pediatric diabetes 23(3), 330-340 (2022). doi:10.1111/pedi.13320
Published by Wiley-Blackwell, Oxford [u.a.]

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d432473c7502a69f77f41bec31842c7Test
https://publications.rwth-aachen.de/record/889488Test

المؤلفون: Ruan, Yue, Elleri, Daniela, Allen, Janet M, Tauschmann, Martin, Wilinska, Malgorzata E, Dunger, David B, Hovorka, Roman

مصطلحات موضوعية: Blood Glucose, Child, Preschool, Cross-Over Studies, Diabetes Mellitus, Type 1, Drug Administration Schedule, Drug Monitoring, Female, Humans, Hypoglycemic Agents, Insulin Aspart, Insulin Infusion Systems, Male, Models, Biological, Treatment Outcome

الوصف: AIMS/HYPOTHESIS: The aim of this study was to compare the pharmacokinetics of two different concentrations of insulin aspart (B28Asp human insulin) in children aged 3-6 years with type 1 diabetes. METHODS: Young children with type 1 diabetes underwent an open-label, randomised, two-period crossover study in a clinical research facility, 2-6 weeks apart. In random order, diluted (1:5 dilution with saline [154 mmol/l NaCl]; 20 U/ml) or standard strength (100 U/ml) insulin aspart was administered via an insulin pump as a meal bolus and then overnight by closed-loop insulin delivery as determined by a model predictive algorithm. Plasma insulin was measured every 30-60 min from 17:00 hours on day 1 to 8:00 hours on day 2. We measured the time-to-peak insulin concentration (tmax), insulin metabolic clearance rate (MCR(I)) and background insulin concentration (ins(c)) using compartmental modelling. RESULTS: Eleven children (six male; age range 3.75-6.96 years, HbA1c 7.6% ± 1.3% [60 ± 14 mmol/mol], BMI standard deviation score 1.0 ± 0.8, duration of diabetes 2.2 ± 1.0 years, total daily dose 12.9 [10.6-16.5] U, fasting C-peptide concentration 5 [5-17.1] pmol/l; mean ± SD or median [interquartile range]) participated in the study. No differences between standard and diluted insulin were observed in terms of t max (59.2 ± 14.4 vs 61.6 ± 8.7) min for standard vs diluted, p = 0.59; MCR I (1.98 × 10(-2) ± 0.99 × 10(-2) vs 1.89 × 10(-2) ± 0.82 × 10(-2) 1/kg/min, p = 0.47), and ins c (34 [1-72] vs 23 [3-65] pmol/l, p = 0.66). However, t max showed less intersubject variability following administration of diluted aspart (SD 14.4 vs 8.7 min, p = 0.047). CONCLUSIONS/INTERPRETATION: Diluting insulin aspart does not change its pharmacokinetics. However, it may result in less variable absorption and could be used in young children with type 1 diabetes undergoing closed-loop insulin delivery. TRIAL REGISTRATION: Clinicaltrials.gov NCT01557634. FUNDING: FUNDING was provided by the JDRF, 7th Framework Programme of the European Union, ...

وصف الملف: application/pdf

العلاقة: https://www.repository.cam.ac.uk/handle/1810/246832Test

الإتاحة: https://www.repository.cam.ac.uk/handle/1810/246832Test

المؤلفون: Fuchs, Julia, Allen, Janet M, Boughton, Charlotte K, Wilinska, Malgorzata E, Thankamony, Ajay, de Beaufort, Carine, Campbell, Fiona, Yong, James, Froehlich-Reiterer, Elke, Mader, Julia K, Hofer, Sabine E, Kapellen, Thomas M, Rami-Merhar, Birgit, Tauschmann, Martin, Hood, Korey, Kimbell, Barbara, Lawton, Julia, Roze, Stephane, Sibayan, Judy, Cohen, Nathan, Hovorka, Roman, KidsAP Consortium

مصطلحات موضوعية: diabetes & endocrinology, general diabetes, paediatric endocrinology, paediatrics, Austria, Blood Glucose, Blood Glucose Self-Monitoring, Child, Preschool, Cross-Over Studies, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Infant, Insulin, Insulin Infusion Systems, Luxembourg, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome

الوصف: INTRODUCTION: Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group. METHODS AND ANALYSIS: The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1-7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1-4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants' and caregivers' experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed. ETHICS AND DISSEMINATION: Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d'Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed ...

وصف الملف: Electronic; application/vnd.openxmlformats-officedocument.wordprocessingml.document

العلاقة: https://www.repository.cam.ac.uk/handle/1810/316119Test

الإتاحة: https://doi.org/10.17863/CAM.63227Test
https://www.repository.cam.ac.uk/handle/1810/316119Test

المؤلفون: KidsAP Consortium, Fuchs, Julia, Allen, Janet M, Boughton, Charlotte K, Wilinska, Malgorzata E, Thankamony, Ajay, de Beaufort, Carine, Campbell, Fiona, Yong, James, Fröhlich-Reiterer, Elke, Mader, Julia K, Hofer, Sabine E, Kapellen, Thomas M, Rami-Merhar, Birgit, Tauschmann, Martin, Hood, Korey, Kimbell, Barbara, Lawton, Julia, Roze, Stephane, Sibayan, Judy, Cohen, Nathan, Hovorka, Roman, Schierloh, Ulrike

المساهمون: Fuchs, Julia [0000-0002-4497-0979], Boughton, Charlotte K [0000-0003-3272-9544], Apollo - University of Cambridge Repository, Clinical sciences

المصدر: BMJ Open
2021, ' Assessing the efficacy, safety and utility of closed-loop insulin delivery compared to sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study) : an open-label, multi-centre, multi-national, randomised crossover study protocol ', BMJ Open . https://doi.org/10.1136/bmjopen-2020-042790Test

مصطلحات موضوعية: Insulin pump, Blood Glucose, medicine.medical_specialty, Luxembourg, Diabetes Mellitus, Type 1/drug therapy, diabetes & endocrinology, Hypoglycemic Agents/therapeutic use, 030209 endocrinology & metabolism, paediatrics, 03 medical and health sciences, 0302 clinical medicine, Insulin Infusion Systems, Quality of life, Diabetes management, medicine, Clinical endpoint, Humans, Hypoglycemic Agents, Insulin, Multicenter Studies as Topic, 030212 general & internal medicine, Child, Randomized Controlled Trials as Topic, Protocol (science), Research ethics, Type 1 diabetes, Cross-Over Studies, business.industry, general diabetes, Blood Glucose Self-Monitoring, Infant, General Medicine, medicine.disease, Crossover study, 3. Good health, Diabetes and Endocrinology, Diabetes Mellitus, Type 1, Treatment Outcome, Insulin/therapeutic use, Austria, Child, Preschool, Physical therapy, Quality of Life, business, paediatric endocrinology

الوصف: IntroductionDiabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.Methods and analysisThe study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1–7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1–4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants’ and caregivers’ experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.Ethics and disseminationEthics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d’Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.Trial registration numberNCT03784027.

وصف الملف: application/vnd.openxmlformats-officedocument.wordprocessingml.document; application/pdf

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc2bcd942c2af450531403bce7871134Test

المؤلفون: Boughton, Charlotte, Allen, Janet M, Tauschmann, Martin, Hartnell, Sara, Wilinska, Malgorzata E, Musolino, Gianluca, Acerini, Carlo L, Dunger, Professor David, Campbell, Fiona, Ghatak, Atrayee, Randell, Tabitha, Besser, Rachel, Trevelyan, Nicola, Elleri, Daniela, Northam, Elizabeth, Hood, Korey, Scott, Eleanor, Lawton, Julia, Roze, Stephane, Sibayan, Judy, Kollman, Craig, Cohen, Nate, Todd, John, Hovorka, Roman, CLOuD Consortium

مصطلحات موضوعية: artificial pancreas, closed-loop, type 1 diabetes, Adolescent, Blood Glucose Self-Monitoring, Child, Diabetes Mellitus, Type 1, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Insulin-Secreting Cells, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Treatment Outcome

الوصف: INTRODUCTION: Management of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy. METHODS AND ANALYSIS: The study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10-16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9-10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (<3.9 mmol/L) at 12 months. Secondary efficacy outcomes include between group differences in stimulated C-peptide AUC at 24 months, time spent in target glucose range, glucose variability, hypoglycaemia and hyperglycaemia as recorded by periodically applied masked continuous glucose monitoring devices, total, basal and bolus insulin dose, and change in body weight. Cognitive, emotional and behavioural characteristics of participants and parents will be evaluated, and a cost-utility analysis performed to support adoption of CL as a standard treatment modality following diagnosis of T1D. ETHICS AND DISSEMINATION: Ethics approval has been obtained from Cambridge East Research Ethics Committee. The ...

وصف الملف: Electronic; application/vnd.openxmlformats-officedocument.wordprocessingml.document

العلاقة: https://www.repository.cam.ac.uk/handle/1810/300402Test

الإتاحة: https://doi.org/10.17863/CAM.47476Test
https://www.repository.cam.ac.uk/handle/1810/300402Test