Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes

Ware, J. et al | 2022 | Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes | N Engl J Med 2022| 386| P. 209-219 | DOI: 10.1056/NEJMoa2111673

This paper outlines the findings of a trial, at the outset the researchers hypothesized that use of the Cambridge closed-loop algorithm for 16 weeks in children 1 to 7 years of age with type 1 diabetes would improve glycemic control, as compared with sensor-augmented pump therapy, and have an acceptable safety profile.

Abstract

Background

The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear.

Methods

In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, more than180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, less than 70 mg per deciliter). Safety was assessed.

Results

A total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7 per cent. The percentage of time with the glucose level in the target range was 8.7 percentage points (95 per cent confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P less than 0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was −8.5 percentage points (95 per cent CI, −9.9 to −7.1), the difference in the glycated hemoglobin level was −0.4 percentage points (95 per cent CI, −0.5 to −0.3), and the difference in the mean sensor glucose level was −12.3 mg per deciliter (95 per cent CI, −14.8 to −9.8) (P less than0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P equal to0.74). The median time spent in the closed-loop mode was 95 per cent (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred.

Conclusions

A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia.

Research summary is available from the NEJM

Full article available from NEJM

Diabetic kidney disease in children and adolescents: an update

Lopez, L.N. et al | 2021 |  Diabetic kidney disease in children and adolescents: an update | Pediatric Nephrology | doi.org/10.1007/s00467-021-05347-7

The reviewers of this article review recent updates to the diagnosis and management of diabetic kidney disease (DKD) in children and adolescents.

The review makes the following key points:

  1. The incidence of diabetes, particularly type 2 diabetes, and its complications, are on the rise in children and adolescents, disproportionately affecting racial-ethnic minorities.
  2. The cornerstone in the prevention of diabetic kidney disease is optimal glycemic control, along with screening for and management of hypertension and albuminuria.
  3. GLP1 receptor agonists, in conjunction with metformin, have been shown to have a beneficial effect in reducing the incidence of adverse kidney outcomes, and are now approved for use in older children with type 2 diabetes.
  4. While many new therapies have been studied and approved for use in adults with diabetes and diabetic kidney disease, insufficient progress has been made in performing clinical trials in children and young adults.

Abstract

Diabetic kidney disease (DKD), previously encountered predominantly in adult patients, is rapidly gaining center stage as a childhood morbidity and one that pediatric nephrologists are likely to encounter with increasing frequency. This is in large part due to the obesity epidemic and the consequent rise in type 2 diabetes in children and adolescents, as well as the more aggressive diabetes phenotype in today’s youth with more rapid beta-cell decline and faster development and progression of diabetes-related complications along with lower responsiveness to the treatments used in adults. DKD, an end-organ complication of diabetes, is at the very least a marker of, and more likely a predisposing factor for, the development of adverse cardiovascular outcomes and premature mortality in children with diabetes. On an optimistic note, several new therapeutic approaches are now available for the management of diabetes in adults, such as GLP1 receptor agonists, SGLT2 inhibitors, and DPP4 inhibitors, that have also been shown to have a favorable impact on cardiorenal outcomes. Also promising is the success of very low-energy diets in inducing remission of diabetes in adults. However, the addition of these pharmacological and dietary approaches to the management toolbox of diabetes and DKD in children and adolescents awaits thorough assessment of their safety and efficacy in this population. This review outlines the scope of diabetes and DKD, and new developments that may favorably impact the management of children and young adults with diabetes and diabetic kidney disease.

The full article is available from Pediatric Nephrology 


Habit and diabetes self-management in adolescents with type 1 diabetes

Cummings, C. et al | 2021| Habit and diabetes self-management in adolescents with type 1 diabetes| Health Psychology | .https://doi.org/10.1037/hea0001097

Objective The development of habit (i.e., behavioral automaticity, the extent to which a behavior is performed with decreased thresholds for time, attention [effort], conscious awareness, and goal dependence), for goal-directed health behaviors facilitates health behavior engagement in daily life. However, there is a paucity of research examining automaticity for Type 1 diabetes self-management in adolescence. This study examined if greater perceived automaticity for diabetes self-management was associated with increased daily self-management, decreased daily self-regulation failures in glucose checking, and more optimal daily glycemic levels in adolescents with Type 1 diabetes.

Method: Adolescents aged 13–17 and diagnosed with Type 1 diabetes (n equal to 79) completed the Self-Report Behavioral Automaticity Index, a measure of automaticity of diabetes self-management (i.e., automaticity of glucose checking, carbohydrate counting, and insulin dosing), and a measure of perceived self-management at baseline. One to 3 months later, a subsample of teens (n equal to 42) also completed a daily diary for a 7-day period including perceptions of daily self-management, daily self-regulation failures in glucose checking, and daily glucose levels.

Results: Greater overall automaticity of diabetes self-management was associated with greater baseline and daily self-management, fewer daily self-regulation failures in glucose checking, and lower average daily mean blood glucose levels but not more optimal daily variations in blood glucose levels.

Conclusions: Greater automaticity for diabetes self-management may support more optimal daily diabetes self-management in adolescence. Further research is needed to clarify the benefits and mechanisms of automaticity and explore possible interventions. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Rotherham NHS staff can request a copy of this article from their Library

Six-figure funding secured to develop chatbot for young people with type 1 diabetes

Sheffield Hallam University | July 2021 | Six-figure funding secured to develop chatbot for young people with type 1 diabetes

Researchers from Sheffield Hallam University and Sheffield Children’s Hospital have secured funding of £800 000 to develop the first NHS-approved chatbot virtual assistant for young people with type 1 diabetes who are moving from paediatric to adult care

Over 50 per cent of young people with chronic health conditions report inadequate support and services during their transition to adult healthcare.

One-third of young people have poor diabetes control by the time of their first adult clinic visit. 

To redress this, the NIHR- funded chatbot will provide support during the transition to adult diabetes services through 24/7 access to relevant, engaging and clinically-approved information that meets individual needs and preferences.

To develop the chat bot the lead authors of the study- Professor Veronica Swallow and her colleagues will provide training and support for the project’s Expert User Advisory Group. They will conduct qualitiative research, focus groups with young people living with type 1 diabetes to find out what they would like included in the chatbot, this will be followed by a trial of young people’s views on the chatbot. Qualitative interviews with the young people and their parents will also be undertaken after the trial will be used to inform the next stage of the project and to see if using the chatbot has helped young people feel better about self-management.

Adapted from Sheffield Hallam’s press release, available in full from the University

Six-figure funding secured to develop chatbot for young people with type 1 diabetes

National Paediatric Diabetes Audit (NPDA) annual reports

Royal College of Paediatrics & Child Health & Health Quality Improvement Programme | June 2021 | National Paediatric Diabetes Audit (NPDA) annual reports

This annual, national report annual, national reports, Care processes and outcomes highlight the main findings on the quality of care for children and young people with diabetes mellitus in England and Wales.

Image source: rcpch.ac.uk

The 2019-20 report- the most current, published June 2021- covers the health checks (care processes) and outcomes for children and young people with diabetes who have attended PDUs (paediatric diabetes units) from 1 April 2019 to 31 March 2020.

The report aims to address a series of questions relating to paediatric diabetes care, which include:

  • What proportion of children and young people with diabetes are reported to be receiving key age-specific processes of diabetes care, as recommended by NICE?
  • How many achieve outcomes within specified treatment targets?
  • Are children and young people with diabetes demonstrating evidence of small vessel (microvascular) disease and/or abnormal risk factors associated with large vessel (macrovascular) disease prior to transition into adult services?

Key messages in the report
  • Paediatric diabetes teams have demonstrated laudable commitment to data driven quality improvement by succeeding in submitting their 2019-20 datasets during the first wave of the COVID-19 pandemic, despite severe disruption to services. 
  • National median HbA1c remained constant at 61.5 mmol/mol between 2018-19 and 2019-20.    
  • Considerable variation in HbA1c target outcomes amongst children and young people with Type 1 diabetes persists between PDUs even after case-mix adjustment. 
  • The completion rates of all recommended health checks for Type 1 diabetes increased between 2018-19 and 2019-20, except for eye screening.
  • The proportion of children and young people with Type 1 diabetes who were assessed as requiring additional psychological or CAMHS support outside of MDT clinics increased from 39.1 per cent in 2018-19 to 43.9 per cent in 2019-20.
  • One fifth (19.4 per cent) of children and young people with Type 1 diabetes were using a real-time continuous glucose monitor (rtCGM). Children using this technology were found to be more likely to be achieving lower HbA1c targets, 
  • Increased use of rtCGM was associated with living in less deprived areas and White ethnicity, with those in the most deprived areas and Black children and young people least likely to be using this technology. 
  • Those living in more deprived areas were found to have a higher risk of retinopathy, albuminuria, needing additional psychological support, and higher HbA1c levels.

See RCPCH for the full suite of resources related to this year’s (and previous year’s) audits

Do adolescent sedentary behavior levels predict type 2 diabetes risk in adulthood?

Scandiffio, J. A., & Janssen, I. et al | 2021| Do adolescent sedentary behavior levels predict type 2 diabetes risk in adulthood? | BMC Public Health | 21| 969 

This longitudinal study builds on the work of a previous study which looked at sedentary behaviour in adolescence to determine whether this predicts type 2 diabetes. The purpose of this study was to determine whether different levels of both screen-based and non-screen based sedentary behaviours during adolescence are associated with the risk of developing type 2 diabetes in adulthood. They studied these associations using data from the 970 British Cohort Study with assessments of sedentary behaviour at age 16 and a subsequent 30-year follow-up for incident cases of type 2 diabetes.

The research team observed that 16-year-olds who watched TV and videos for more than 4 h/day had a twofold increased risk for developing type 2 diabetes over the next three decades

Time spent using a computer, doing homework, and reading at age 16 were not associated with type 2 diabetes risk.

Abstract
Background

The objective was to determine whether time spent in different types of sedentary behavior during adolescence are associated with the risk of developing type 2 diabetes in adulthood.

Methods

Participants were 3 942 adolescents aged 16 years who were part of the 1970 British Cohort Study. Sedentary behavior was assessed using a questionnaire that asked participants to indicate how much time they spent watching TV and videos, using the computer, reading, and doing homework. Incident cases of type 2 diabetes were determined quadrennially until 46 years of age. The association between adolescent sedentary behaviors and type 2 diabetes was determined using Cox proportional hazards regression that controlled for sex, body mass index, sugary beverage consumption, smoking status, physical activity at baseline, and physical activity in adulthood .

Results

There were 91 incident cases of type 2 diabetes with an incidence rate of 9 cases/10,000 person-years. By comparison to those who watched TV and videos for 2 or less hours/day, type 2 diabetes risk was not different in those who watched for 2.1–4.0 h/day (HR equal to 0.89, 95 per cent CI  equal to  0.54, 1.47) but was increased by 2.06-fold (95 per cent CI  equal to  1.24, 3.43) in those who watched for more than 4 h/day. Time spent using a computer, reading, and doing homework were not significantly associated with type 2 diabetes.

Conclusion

Spending more than 4 h/day watching television and videos at age 16 was associated with an increased risk of type 2 diabetes. Conversely, using a computer and non-screen based sedentary behaviors were not associated with type 2 diabetes risk.

Primary paper Do adolescent sedentary behavior levels predict type 2 diabetes risk in adulthood?

Impact of Type 1 Diabetes in the Developing Brain in Children: A Longitudinal Study

Published in the latest edition of Diabetes Care is a longitudinal study which followed children with type 1 and a control gropu with no diabetes for up to 12 years.

Objective

 To assess whether previously observed brain and cognitive differences between children with type 1 diabetes and control subjects without diabetes persist, worsen, or improve as children grow into puberty and whether differences are associated with hyperglycemia.

Research design and methods

One hundred forty-four children with type 1 diabetes and 72 age-matched control subjects without diabetes (mean ± SD age at baseline 7.0 ± 1.7 years, 46% female) had unsedated MRI and cognitive testing up to four times over 6.4 ± 0.4 (range 5.3–7.8) years; HbA1c and continuous glucose monitoring were done quarterly. FreeSurfer-derived brain volumes and cognitive metrics assessed longitudinally were compared between groups using mixed-effects models at 6, 8, 10, and 12 years. Correlations with glycemia were performed.

Results

Total brain, gray, and white matter volumes and full-scale and verbal intelligence quotients (IQs) were lower in the diabetes group at 6, 8, 10, and 12 years, with estimated group differences in full-scale IQ of −4.15, −3.81, −3.46, and −3.11, respectively (P  less than 0.05), and total brain volume differences of −15,410, −21,159, −25,548, and −28,577 mm3 at 6, 8, 10, and 12 years, respectively (P  less than 0.05). Differences at baseline persisted or increased over time, and brain volumes and cognitive scores negatively correlated with a life-long HbA1c index and higher sensor glucose in diabetes.

Conclusions

 Detectable changes in brain volumes and cognitive scores persist over time in children with early-onset type 1 diabetes followed longitudinally; these differences are associated with metrics of hyperglycemia. Whether these changes can be reversed with scrupulous diabetes control requires further study. These longitudinal data support the hypothesis that the brain is a target of diabetes complications in young childre

The pandemic is negatively impacting young people with diabetes

Diabetes UK | April  2021 | The pandemic is negatively impacting young people with diabetes

Researchers from King’s College London studying the impact of lockdown and the coronavirus pandemic on young people with diabetes, have presented the findings of their study at this year’s virtual Diabetes UK Professional Conference (DUKPC) this week.

As part of this they have undertaken qualitative research to survey 74 young people with the condition, to better understand their diabetes management as well as their emotional wellbeing. While a little over half (55 per cent) of the participants felt they were well-supported by diabetes team, more than one in five (22 per cent) experienced feelings of ‘demotivation’ which ascribed to being less physically active, disrupted diabetes routines and a lack of support. Equally, Almost two-thirds of people said the pandemic had had a negative impact on their mental wellbeing, and 31 per cent of respondents felt more negatively about their diabetes and future health.

Overall two-thirds of those young people surveyed were looking forward to returning to face-to-face care

Further details available from Diabetes UK

Depression in Youth-Onset Type 2 Diabetes

Gulley, L.D. & Shomaker, L. B. (2020) |Depression in Youth-Onset Type 2 Diabetes | Current Diabetes Reports | 20| 51 

This study highlights the paucity of literature around youth onset type 2 diabetes (T2D), and synthesizes what is known about the prevalence of depression in this particular patient group.

Abstract

Purpose of Review

The current review summarizes extant knowledge regarding the prevalence of depression in youth-onset type 2 diabetes (T2D) and how depression might impact glycemic control through stress-related behavioral and physiological mechanisms. The current review also discusses depression intervention studies in adult-onset T2D, as there are no such studies in youth-onset T2D, and provides recommendations for clinical research.

Recent Findings

The prevalence of elevated depression symptoms in youth-onset T2D is approximately 20%. Some studies suggest depression may negatively impact glycemic control through inadequate medication adherence and disordered eating, but there is a dearth of studies investigating associations with depression and physical activity/sedentary time, sleep, and stress-related physiological mechanisms. In adult-onset T2D, evidence-based behavioral interventions tailored to address diabetes-related issues have shown positive effects for depression and glycemic control.

Summary

Future research is needed to characterize the epidemiology of depression in youth-onset T2D and test interventions to improve depression, glycemic control, and health outcomes in this specific pediatric population.

The full article can be requested by Rotherham NHS staff here 

Exploring the effects of being diagnosed with type 1 diabetes in adolescence

Corbett, T. & Smith, J. ( 2020). Exploring the effects of being diagnosed with type 1 diabetes in adolescence. Nursing Times. doi: 10.7748/ns.2020.e11556

Type 1 diabetes is a complex long-term condition for which there is no cure. It can have significant consequences for patients, who need to adapt their lives to a demanding regimen of insulin therapy and will be at risk of various health complications, some of which are potentially fatal. A diagnosis of type 1 diabetes may come as a shock and may be challenging for the patient to accept, and when the condition is diagnosed in adolescence it is likely to compound the challenges many young people experience during this crucial developmental period. This article explores the effects of being diagnosed with type 1 diabetes in adolescence and describes the challenges involved in the management of this condition. It also outlines the role of the nurse in caring for and supporting adolescents with type 1 diabetes.

Request a copy of this article  from the Library & Knowledge Service