Lower plasma insulin levels during overnight closed-loop in school children with type 1 diabetes: Potential advantage? A randomized cross-over trial.

BACKGROUND: Studies have shown that overnight closed-loop insulin delivery can improve glucose control and reduce the risk of hypoglycemia and hence may improve metabolic outcomes and reduce burden for children with type 1 diabetes and their families. However, research so far has not reported insulin levels while comparing closed-loop to open-loop insulin delivery in children. Therefore, in this study we obtained glucose levels as well as plasma insulin levels in children with type 1 diabetes to evaluate the efficacy of a model-based closed-loop algorithm compared to an open-loop administration. METHODS: Fifteen children with type 1 diabetes, 6-12 years, participated in this open-label single center study. We used a randomized cross over design in which we compared overnight closed-loop insulin delivery with sensor augmented pump therapy for two nights in both the hospital and at home (i.e., 1 night in-patient stay and at home per treatment condition). Only during the in-patient stay, hourly plasma insulin and blood glucose levels were assessed and are reported in this paper. RESULTS: Results of paired sample t-tests revealed that although plasma insulin levels were significantly lower during the closed-loop than in the open-loop (Mean difference 36.51 pmol/l; t(13) = 2.13, p = .03, effect size d = 0.57), blood glucose levels did not vary between conditions (mean difference 0.76 mmol/l; t(13) = 1.24, p = .12, d = 0.37). The administered dose of insulin was significantly lower during the closed-loop compared with the open-loop (mean difference 0.10 UI; t(12) = 2.45, p = .02, d = 0.68). CONCLUSIONS: Lower insulin doses were delivered in the closed-loop, resulting in lower plasma insulin levels, whereby glucose levels were not affected negatively. This suggests that the closed-loop administration is better targeted and hence could be more effective

Psychological Well-Being of Parents of Very Young Children With Type 1 Diabetes – Baseline Assessment

Background: Type 1 diabetes in young children is a heavy parental burden. As part of pilot phase of the KIDSAP01 study, we conducted a baseline assessment in parents to study the association between hypoglycemia fear, parental well-being and child behavior. Methods: All parents were invited to fill in baseline questionnaires: hypoglycemia fear survey (HFS), WHO-5, Epworth Sleepiness Scale and Strength and Difficulties Questionnaire (SDQ). Results: 24 children (median age: 5-year, range 1-7 years, 63% male, mean diabetes duration: 3 ± 1.7 years) participated. 23/24 parents filled out the questionnaires. We found a higher score for the hypoglycemia fear behavior 33.9 ± 5.6 compared to hypoglycemia worry 34.6 ± 12.2. Median WHO-5 score was 16 (8 - 22) with poor well-being in two parents. Median daytime sleepiness score was high in five parents (>10). For six children a high total behavioral difficulty score (>16) was reported. Pro social behavior score was lower than normal in six children (<6). Parental well-being was negatively associated with HFS total (r = - 0.50, p <.05) and subscale scores (r = - 0.44, p <.05 for HFS-Worry and HFS-Behavior), child behavior (r = - 0.45, p = .05) and positively with child age and diabetes duration (r = 0.58, p <.01, r = 0.6, p <.01). HFS, parental well-being nor daytime sleepiness are associated with the HbA1c. Conclusion: Regular screening of parental well-being, hypoglycemia fear and child behavior should be part of routine care to target early intervention

Cambridge hybrid closed-loop system in very young children with type 1 diabetes reduces caregivers’ fear of hypoglycemia and improves their well-being

Objective To evaluate the impact of CamAPS FX hybrid closed-loop automated insulin delivery (HCL) in very young children with type 1 diabetes (T1D) on caregivers’ well-being, fear of hypoglycemia and sleepiness. Research Design Multinational, open label, randomized crossover study. Children (1-7years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (SAP) (control). At baseline and after each treatment period, caregivers were invited to complete WHO-5, Hypoglycemia Fear Survey (HFS) and Epworth Sleepiness Scale (ESS). Results Caregivers of 74 children (mean±SD: age 5±2 years; 42% female, baseline HbA1c 7.3±0.7%) participated. Results revealed significantly lower scores for hypoglycemia fear (p<.001) and higher for well-being (p<.001) after HCL treatment. A trend towards a reduction in sleepiness score was observed (p=0.09). Conclusion Our results suggest a better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL

Temporal trends in diabetic ketoacidosis at diagnosis of paediatric type 1 diabetes between 2006 and 2016: results from 13 countries in three continents

Aims/hypothesis The aim of this work was to evaluate geographical variability and trends in the prevalence of diabetic ketoacidosis (DKA), between 2006 and 2016, at the diagnosis of childhood-onset type 1 diabetes in 13 countries over three continents. Methods An international retrospective study on DKA at diagnosis of diabetes was conducted. Data on age, sex, date of diabetes diagnosis, ethnic minority status and presence of DKA at diabetes onset were obtained from Australia, Austria, Czechia, Denmark, Germany, Italy, Luxembourg, New Zealand, Norway, Slovenia, Sweden, USA and the UK (Wales). Mean prevalence was estimated for the entire period, both overall and by country, adjusted for sex and age group. Temporal trends in annual prevalence of DKA were estimated using logistic regression analysis for each country, before and after adjustment for sex, age group and ethnic minority status. Results During the study period, new-onset type 1 diabetes was diagnosed in 59,000 children (median age [interquartile range], 9.0 years [5.5–11.7]; male sex, 52.9%). The overall adjusted DKA prevalence was 29.9%, with the lowest prevalence in Sweden and Denmark and the highest in Luxembourg and Italy. The adjusted DKA prevalence significantly increased over time in Australia, Germany and the USA while it decreased in Italy. Preschool children, adolescents and children from ethnic minority groups were at highest risk of DKA at diabetes diagnosis in most countries. A significantly higher risk was also found for females in Denmark, Germany and Slovenia. Conclusions/interpretation DKA prevalence at type 1 diabetes diagnosis varied considerably across countries, albeit it was generally high and showed a slight increase between 2006 and 2016. Increased awareness of symptoms to prevent delay in diagnosis is warranted, especially in preschool children, adolescents and children from ethnic minority groups

Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study.

BACKGROUND: In attempting to achieve optimal metabolic control, the day-to-day management is challenging for a child with type 1 diabetes (T1D) and his family and can have a major negative impact on their quality of life. Augmenting an insulin pump with glucose sensor information leads to improved outcomes: decreased haemoglobin A1c levels, increased time in glucose target and less hypoglycaemia. Fear of nocturnal hypoglycaemia remains pervasive amongst parents, leading to chronic sleep interruption and lack of sleep for the parents and their children. The QUEST study, an open-label, single-centre randomized crossover study, aims to evaluate the impact on time in target, in hypoglycaemia and hyperglycaemia and the effect on sleep and quality of life in children with T1D, comparing a sensor-augmented pump (SAP) with predictive low glucose suspend and alerts to the use of the same insulin pump with a flash glucose measurement (FGM) device not interacting with the pump. METHODS/DESIGN: Subjects meeting the inclusion criteria are randomized to treatment with the SAP or treatment with an insulin pump and independent FGM for 5 weeks. Following a 3-week washout period, the subjects cross over to the other study arm for 5 weeks. During the week before and in the last week of treatment, the subjects and one of their caregivers wear a sleep monitor in order to obtain sleep data. The primary endpoint is the between-arm difference in percentage of time in glucose target during the final 6 days of each treatment arm, measured by a blinded continuous glucose measurement (CGM). Additional endpoints include comparison of quantity and quality of sleep as well as quality of life perception of the subjects and one of their caregivers in the two different treatment arms. Recruitment started in February 2017. A total of 36 patients are planned to be randomized. The study recruitment was completed in April 2018. DISCUSSION: With this study we will provide more information on whether insulin pump treatment combined with more technology (SmartGuard® feature and alerts) leads to better metabolic control. The inclusion of indicators on quality of sleep with less sleep interruption, less lack of sleep and perception of quality of life in both children and their primary caregivers is essential for this study and might help to guide us to further treatment improvement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03103867 . Registered on 6 April 2017

Psychological Well-Being of Parents of Very Young Children With Type 1 Diabetes – Baseline Assessment

Background: Type 1 diabetes in young children is a heavy parental burden. As part of pilot phase of the KIDSAP01 study, we conducted a baseline assessment in parents to study the association between hypoglycemia fear, parental well-being and child behavior. Methods: All parents were invited to fill in baseline questionnaires: hypoglycemia fear survey (HFS), WHO-5, Epworth Sleepiness Scale and Strength and Difficulties Questionnaire (SDQ). Results: 24 children (median age: 5-year, range 1-7 years, 63% male, mean diabetes duration: 3 ± 1.7 years) participated. 23/24 parents filled out the questionnaires. We found a higher score for the hypoglycemia fear behavior 33.9 ± 5.6 compared to hypoglycemia worry 34.6 ± 12.2. Median WHO-5 score was 16 (8 - 22) with poor well-being in two parents. Median daytime sleepiness score was high in five parents (>10). For six children a high total behavioral difficulty score (>16) was reported. Pro social behavior score was lower than normal in six children (<6). Parental well-being was negatively associated with HFS total (r = - 0.50, p <.05) and subscale scores (r = - 0.44, p <.05 for HFS-Worry and HFS-Behavior), child behavior (r = - 0.45, p = .05) and positively with child age and diabetes duration (r = 0.58, p <.01, r = 0.6, p <.01). HFS, parental well-being nor daytime sleepiness are associated with the HbA1c. Conclusion: Regular screening of parental well-being, hypoglycemia fear and child behavior should be part of routine care to target early intervention

Lower plasma insulin levels during overnight closed loop in schoolchildren with type 1 diabetes: potential advantage?

Background Studies have shown that overnight closed-loop insulin delivery can improve glucose control and reduce the risk of hypoglycemia and hence may improve metabolic outcomes and reduce burden for children with type 1 diabetes and their families. However, research so far has not reported insulin levels while comparing closed-loop to open-loop insulin delivery in children. Therefore, in this study we obtained glucose levels as well plasma insulin levels in children with type 1 diabetes to evaluate the efficacy of a model - based closed-loop algorithm compared to an open-loop administration. Methods Fifteen children with type 1 diabetes, 6-12 years, participated in this open-label single center study. We used a randomized cross over design in which we compared overnight closed-loop insulin delivery with sensor augmented pump therapy for two nights in both the hospital and at home (i.e., 1 night in-patient stay and at home per treatment condition). Only during the in-patient stay, hourly plasma insulin and blood glucose levels were assessed and are reported in this paper. Results Results of paired sample t-tests revealed that although plasma insulin levels were significantly lower during the closed-loop than in the open-loop (Mean difference 36.51 pmol/l; t(13)=2.13, p=.03, effect size d= 0.57), blood glucose levels did not vary between conditions (mean difference 0.76 mmol/l; t(13)=1.24, p=.12, d=0.37). The administered dose of insulin was significantly lower during the closed-loop compared with the open-loop (mean difference 0.10 UI; t(12)=2.45, p=.02, d=0.68). Conclusions Lower insulin doses were delivered in the closed-loop, resulting in lower plasma insulin levels , whereby glucose levels were not affected negatively. This suggests that the closed-loop administration is better targeted and hence could be more effective

Can health indicators and psychosocial characteristics predict attrition in youths with overweight and obesity seeking ambulatory treatment? Data from a retrospective longitudinal study in a paediatric clinic in Luxembourg

Objectives The current study aimed to identify factors that could predict attrition in youths starting ambulatory treatment to control or lose weight. Design Retrospective longitudinal study. Setting Paediatric clinic: ambulatory treatment programme. Patients and measures A youth sample (n=191; 89 boys; aged 7-17 years) completed measures of demographic characteristics, and health and psychosocial traits before starting an ambulatory weight management programme. Anthropometric and biological markers related to obesity were also obtained. Tests of mean differences and regression analyses were used to investigate the relationship between these variables and attrition after 1 year. Results The 2 and t test results showed both psychosocial and health indicators differentiated between participants who continued attending the treatment programme and those who dropped out. More specifically, youths that dropped out of treatment were significantly older, had higher body mass index z scores, higher levels of insulin, triglycerides and HOMA-IR, reported poorer health, had more conduct problems and were more dissatisfied with themselves and their bodies before starting treatment. Results of regression analyses revealed that weight status (anthropometric and biological markers), age and body dissatisfaction predicted attrition (overall prediction success 73%; prediction success for continued attendance 90/91%; prediction success for dropouts 42/44%). Conclusion Attrition, but especially the continued attendance in treatment, can be successfully predicted by age, weight status and body dissatisfaction. For patients who present with one or more risk factors, careful consideration is needed to decide which (combination of) inpatient or outpatient programme may facilitate prolonged engagement of the patient and hence may be most effective in establishing weight loss