What Training, Support, and Resourcing Do Health Professionals Need to Support People Using a Closed-Loop System? A Qualitative Interview Study with Health Professionals Involved in the Closed Loop from Onset in Type 1 Diabetes (CLOuD) Trial.

Background: We explored health professionals' views about the training, support, and resourcing needed to support people using closed-loop technology in routine clinical care to help inform the development of formal guidance. Methods: Interviews were conducted with health professionals (n = 22) delivering the Closed Loop from Onset in Type 1 Diabetes (CLOuD) trial after they had ≥6 months' experience of supporting participants using a closed-loop system. Data were analyzed descriptively. Results: Interviewees described how, compared with other insulin regimens, teaching and supporting individuals to use a closed-loop system could be initially more time-consuming. However, they also noted that after an initial adjustment period, users had less need for initiating contact with the clinical team compared with people using pumps or multiple daily injections. Interviewees highlighted how a lessened need for ad hoc clinical input could result in new challenges; specifically, they had fewer opportunities to reinforce users' diabetes knowledge and skills and detect potential psychosocial problems. They also observed heightened anxiety among some parents due to the constant availability of data and unrealistic expectations about the system's capabilities. Interviewees noted that all local diabetes teams should be empowered to deliver closed-loop system care, but stressed that health professionals supporting closed-loop users in routine care will need comprehensive technology training and standardized clinical guidance. Conclusion: These findings constitute an important starting point for the development of formal guidance to support the rollout of closed-loop technology. Our recommendations, if actioned, will help limit the potential additional burden of introducing closed-loop systems in routine clinical care and help inform appropriate user education and support.NIHR Wellcome Trust Strategic Award (100574/Z/12/Z

Assessing the effect of closed-loop insulin delivery from onset of type 1 diabetes in youth on residual beta-cell function compared to standard insulin therapy (CLOuD study): a randomised parallel study protocol.

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 results will be disseminated by peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT02871089; Pre-results

Adolescents’ Experiences of Using a Smartphone Application Hosting a Closed-loop Algorithm to Manage Type 1 Diabetes in Everyday Life: Qualitative Study

Background:: Closed-loop technology may help address health disparities experienced by adolescents, who are more likely to have suboptimal glycemic control than other age groups and, because of their age, find diabetes self-management particularly challenging. The CamAPS FX closed-loop has sought to address accessibility and usability issues reported by users of previous prototype systems. It comprises small components and a smartphone app used to: announce meal-time boluses, adjust (“boost” or “ease-off”) closed-loop insulin delivery, customize alarms, and review/share data. We explored how using the CamAPS FX platform influences adolescents’ self-management practices and everyday lives. Methods:: Eighteen adolescents were interviewed after having ≥6 months experience using the closed-loop platform. Data were analyzed thematically. Results:: Participants reported feeling less burdened and shackled by diabetes because closed-loop components were easier to carry/wear, finger-pricks were not required, the smartphone app provided a discreet and less stigmatizing way of managing diabetes in public, and they were able to customize alarms. Participants also reported checking and reviewing data more regularly, because they did so when using the smartphone for other reasons. Some reported challenges in school settings where use of personal phones was restricted. Participants highlighted how self-management practices were improved because they could easily review glucose data and adjust closed-loop insulin delivery using the “boost” and “ease-off” functions. Some described how using the system resulted in them forgetting about diabetes and neglecting certain tasks. Conclusions:: A closed-loop system with small components and control algorithm on a smartphone app can enhance usability and acceptability for adolescents and may help address the health-related disparities experienced by this age group. However, challenges can arise from using a medical app on a device which doubles as a smartphone. Trial registration:: Closed Loop From Onset in Type 1 Diabetes (CLOuD); NCT02871089; https://clinicaltrials.gov/ct2/show/NCT0287108

Time spent in hypoglycemia according to age and time-of-day: Observations during closed-loop insulin delivery.

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 <3.9mmol/l. Eight weeks of data for 88 participants were analyzed. RESULTS Median time spent in hypoglycemia over the 24-hour period was highest in children and adolescents (4.4%; [IQR 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

Treating vitamin D deficiency in children with type I diabetes could improve their glycaemic control

Background and aims The relationship between vitamin D deficiency and type I DM is an ongoing area of interest. The study aims to identify the prevalence of vitamin D deficiency in children and adolescents with T1DM and to assess the impact of treatment of vitamin D deficiency on their glycaemic control. Methods Retrospective data was collected from 271 children and adolescents with T1DM. The vitamin D deficient (25(OH)D <30 nmol/L) and insufficient (25(OH)D 30–50 nmol/L) patients were treated with 6000 units of cholecalciferol and 400 units of cholecalciferol, once daily for 3 months respectively. HbA1c and 25(OH)D concentrations were measured before and at the end of the vitamin D treatment. Results 14.8% from the whole cohort (n = 271) were vitamin D deficient and 31% were insufficient. Among the children included in the final analysis (n = 73), the mean age and plasma 25(OH)D concentration (±SD) were 7.7 years (±4.4) and 32.2 nmol/l (±8.2) respectively. The mean 25(OH)D concentration post-treatment was 65.3 nmol/l (±9.3). The mean HbA1c (±SD) before and after cholecalciferol was 73.5 mmol/mol (±14.9) and 65 mmol/mol (±11.2) respectively (p < 0.001). Children with higher pre-treatment HbA1c had greater reduction in HbA1c (p < 0.001) and those with lower 25(OH)D concentration showed higher reduction in HbA1c (p = 0.004) after treatment. Conclusions Low 25(OH)D concentrations are fairly prevalent in children and adolescents with T1DM, treatment of which, can potentially improve the glycaemic control

Long-term assessment of the NHS hybrid closed-loop real-world study on glycaemic outcomes, time-in-range, and quality of life in children and young people with type 1 diabetes.

Hybrid closed-loop (HCL) systems seamlessly interface continuous glucose monitoring (CGM) with insulin pumps, employing specialised algorithms and user-initiated automated insulin delivery. This study aimed to assess the efficacy of HCLs at 12 months post-initiation on glycated haemoglobin (HbA1c), time-in-range (TIR), hypoglycaemia frequency, and quality of life measures among children and young people (CYP) with type 1 diabetes mellitus (T1DM) and their caregivers in a real-world setting. Conducted between August 1, 2021, and December 10, 2022, the prospective recruitment took place in eight paediatric diabetes centres across England under the National Health Service England's (NHSE) HCL pilot real-world study. A cohort of 251 CYP (58% males, mean age 12.3 years) with T1DM participated (89% white, 3% Asian, 4% black, 3% mixed ethnicity, and 1% other). The study utilised three HCL systems: (1) Tandem Control-IQ AP system, which uses the Tandem t:slim X2 insulin pump (Tandem Diabetes Care, San Diego, CA, USA) with the Dexcom G6® CGM (Dexcom, San Diego, CA, USA) sensor; (2) Medtronic MiniMed™ 780G with the Guardian 4 sensor (Medtronic, Northridge, CA, USA); and (3) the CamAPS FX (CamDiab, Cambridge, UK) with the Ypsomed insulin pump (Ypsomed Ltd, Escrick, UK) and Dexcom G6® CGM.All systems were fully funded by the NHS. Results demonstrated significant improvements in HbA1c (average reduction at 12 months 7 mmol/mol; P < 0.001), time-in-range (TIR) (average increase 13.4%; P < 0.001), hypoglycaemia frequency (50% reduction), hypoglycaemia fear, and quality of sleep (P < 0.001) among CYP over a 12-month period of HCL usage. Additionally, parents and carers experienced improvements in hypoglycaemia fear and quality of sleep after 6 and 12 months of use. In addition to the improvements in glycaemic management, these findings underscore the positive impact of HCL systems on both the well-being of CYP with T1DM and the individuals caring for them

Data Sharing While Using a Closed-Loop System: Qualitative Study of Adolescents' and Parents' Experiences and Views.

Objective: To understand and explore data sharing practices among adolescents and their parents using a closed-loop system. Methods: Eighteen adolescents (aged 11-18 years) and 19 parents were interviewed after adolescents had ∼6 months experience of using a closed-loop system, which permitted them to share glucose and insulin data with parents/caregivers. Data were analyzed thematically. Results: There was considerable variability in how parent-child dyads perceived, valued, and undertook data sharing. Parents of early adolescents (11-13 years) reported making extensive use of "real time" data to remotely manage their child's diabetes and early adolescents described needing and wanting this input. Parents of middle adolescents (14-16 years) described making greater use of retrospective data. To avoid conflict and encourage and support their son/daughter's autonomy, these individuals reported practicing watchful waiting and only intervening after concerns about a pattern of problematic behavior or their child's safety arose. Middle adolescents indicated that data sharing had been done primarily for the benefit of their parents, although they also noted quality of life benefits for themselves. Among late adolescents (17+ years), parents were simply remote because their son/daughter had not permitted access to their data. Participants recommended clear ground rules be put in place about when, and how, data sharing should be used. Conclusions: To help parent-child dyads use data sharing in ways which minimize conflict and optimize constructive parental support, we recommend tailored input and support, which takes account of family dynamics, the young person's developmental maturity, and the different ways in which data are used across the adolescent age range

Data Sharing While Using a Closed-Loop System: Qualitative Study of Adolescents' and Parents' Experiences and Views.

Objective: To understand and explore data sharing practices among adolescents and their parents using a closed-loop system. Methods: Eighteen adolescents (aged 11-18 years) and 19 parents were interviewed after adolescents had ∼6 months experience of using a closed-loop system, which permitted them to share glucose and insulin data with parents/caregivers. Data were analyzed thematically. Results: There was considerable variability in how parent-child dyads perceived, valued, and undertook data sharing. Parents of early adolescents (11-13 years) reported making extensive use of "real time" data to remotely manage their child's diabetes and early adolescents described needing and wanting this input. Parents of middle adolescents (14-16 years) described making greater use of retrospective data. To avoid conflict and encourage and support their son/daughter's autonomy, these individuals reported practicing watchful waiting and only intervening after concerns about a pattern of problematic behavior or their child's safety arose. Middle adolescents indicated that data sharing had been done primarily for the benefit of their parents, although they also noted quality of life benefits for themselves. Among late adolescents (17+ years), parents were simply remote because their son/daughter had not permitted access to their data. Participants recommended clear ground rules be put in place about when, and how, data sharing should be used. Conclusions: To help parent-child dyads use data sharing in ways which minimize conflict and optimize constructive parental support, we recommend tailored input and support, which takes account of family dynamics, the young person's developmental maturity, and the different ways in which data are used across the adolescent age range

Closed-Loop Therapy and Preservation of C-Peptide Secretion in Type 1 Diabetes.

BACKGROUND: Whether improved glucose control with hybrid closed-loop therapy can preserve C-peptide secretion as compared with standard insulin therapy in persons with new-onset type 1 diabetes is unclear. METHODS: In a multicenter, open-label, parallel-group, randomized trial, we assigned youths 10.0 to 16.9 years of age within 21 days after a diagnosis of type 1 diabetes to receive hybrid closed-loop therapy or standard insulin therapy (control) for 24 months. The primary end point was the area under the curve (AUC) for the plasma C-peptide level (after a mixed-meal tolerance test) at 12 months after diagnosis. The analysis was performed on an intention-to-treat basis. RESULTS: A total of 97 participants (mean [±SD] age, 12±2 years) underwent randomization: 51 were assigned to receive closed-loop therapy and 46 to receive control therapy. The AUC for the C-peptide level at 12 months (primary end point) did not differ significantly between the two groups (geometric mean, 0.35 pmol per milliliter [interquartile range, 0.16 to 0.49] with closed-loop therapy and 0.46 pmol per milliliter [interquartile range, 0.22 to 0.69] with control therapy; mean adjusted difference, -0.06 pmol per milliliter [95% confidence interval {CI}, -0.14 to 0.03]). There was not a substantial between-group difference in the AUC for the C-peptide level at 24 months (geometric mean, 0.18 pmol per milliliter [interquartile range, 0.06 to 0.22] with closed-loop therapy and 0.24 pmol per milliliter [interquartile range, 0.05 to 0.30] with control therapy; mean adjusted difference, -0.04 pmol per milliliter [95% CI, -0.14 to 0.06]). The arithmetic mean glycated hemoglobin level was lower in the closed-loop group than in the control group by 4 mmol per mole (0.4 percentage points; 95% CI, 0 to 8 mmol per mole [0.0 to 0.7 percentage points]) at 12 months and by 11 mmol per mole (1.0 percentage points; 95% CI, 7 to 15 mmol per mole [0.5 to 1.5 percentage points]) at 24 months. Five cases of severe hypoglycemia occurred in the closed-loop group (in 3 participants), and one occurred in the control group; one case of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In youths with new-onset type 1 diabetes, intensive glucose control for 24 months did not appear to prevent the decline in residual C-peptide secretion. (Funded by the National Institute for Health and Care Research and others; CLOuD ClinicalTrials.gov number, NCT02871089.)