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

Trends in all-cause mortality among people with diagnosed diabetes in high-income settings: a multicountry analysis of aggregate data

Prof Dianna J Magliano, D. J. et al | 2021 | Trends in all-cause mortality among people with diagnosed diabetes in high-income settings: a multicountry analysis of aggregate data | The Lancet Diabetes & Endocrinology | DOI:https://doi.org/10.1016/S2213-8587(21)00327-2

Summary

Background

Population-level trends in mortality among people with diabetes are inadequately described. We aimed to examine the magnitude and trends in excess all-cause mortality in people with diabetes.

Methods

In this retrospective, multicountry analysis, we collected aggregate data from 19 data sources in 16 high-income countries or jurisdictions (in six data sources in Asia, eight in Europe, one from Australia, and four from North America) for the period from Jan 1, 1995, to Dec 31, 2016, (or a subset of this period) on all-cause mortality in people with diagnosed total or type 2 diabetes. We collected data from administrative sources, health insurance records, registries, and a health survey. We estimated excess mortality using the standardised mortality ratio (SMR).

Findings

In our dataset, there were approximately 21 million deaths during 0·5 billion person-years of follow-up among people with diagnosed diabetes. 17 of 19 data sources showed decreases in the age-standardised and sex-standardised mortality in people with diabetes, among which the annual percentage change in mortality ranged from –0·5 per cent (95 per cent CI –0·7 to –0·3) in Hungary to –4·2 per cent (−4·3 to –4·1) in Hong Kong. The largest decreases in mortality were observed in east and southeast Asia, with a change of –4·2 per cent (95 per cent CI –4·3 to –4·1) in Hong Kong, –4·0 per cent (−4·8 to –3·2) in South Korea, –3·5 per cent (−4·0 to –3·0) in Taiwan, and –3·6 per cent (−4·2 to –2·9) in Singapore. The annual estimated change in SMR between people with and without diabetes ranged from –3·0 per cent (95 per cent CI –3·0 to –2·9; US Medicare) to 1·6 per cent (1·4 to 1·7; Lombardy, Italy). Among the 17 data sources with decreasing mortality among people with diabetes, we found a significant SMR increase in five data sources, no significant SMR change in four data sources, and a significant SMR decrease in eight data sources.

Interpretation

All-cause mortality in diabetes has decreased in most of the high-income countries we assessed. In eight of 19 data sources analysed, mortality decreased more rapidly in people with diabetes than in those without diabetes. Further longevity gains will require continued improvement in prevention and management of diabetes.

Funding

US Centers for Disease Control and Prevention, Diabetes Australia Research Program, and Victoria State Government Operational Infrastructure Support Program

Trends in all-cause mortality among people with diagnosed diabetes in high-income settings: a multicountry analysis of aggregate data [abstract only]

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Adult-Onset Type 1 Diabetes: Current Understanding and Challenges

Adult-Onset Type 1 Diabetes: Current Understanding and Challenges David Leslie, R. et al | 2021 | Diabetes Care | 44| 11| P. 2449-2456 |  DOI: 10.2337/dc21-0770

Abstract

Recent epidemiological data have shown that more than half of all new cases of type 1 diabetes occur in adults. Key genetic, immune, and metabolic differences exist between adult- and childhood-onset type 1 diabetes, many of which are not well understood. A substantial risk of misclassification of diabetes type can result. Notably, some adults with type 1 diabetes may not require insulin at diagnosis, their clinical disease can masquerade as type 2 diabetes, and the consequent misclassification may result in inappropriate treatment. In response to this important issue, JDRF convened a workshop of international experts in November 2019. Here, we summarize the current understanding and unanswered questions in the field based on those discussions, highlighting epidemiology and immunogenetic and metabolic characteristics of adult-onset type 1 diabetes as well as disease-associated comorbidities and psychosocial challenges. In adult-onset, as compared with childhood-onset, type 1 diabetes, HLA-associated risk is lower, with more protective genotypes and lower genetic risk scores; multiple diabetes-associated autoantibodies are decreased, though GADA remains dominant. Before diagnosis, those with autoantibodies progress more slowly, and at diagnosis, serum C-peptide is higher in adults than children, with ketoacidosis being less frequent. Tools to distinguish types of diabetes are discussed, including body phenotype, clinical course, family history, autoantibodies, comorbidities, and C-peptide. By providing this perspective, we aim to improve the management of adults presenting with type 1 diabetes.

This Perspective piece published in the journal Diabetes Care , based on that workshop, the participants outline the evidence for a new viewpoint, suggesting future directions of research and ways to alter disease management to help adults living with type 1 diabetes. They also outline a roadmap for addressing these deficiencies (Fig. 1). A cornerstone of this roadmap is a renewed emphasis on the careful consideration of the underlying etiology of diabetes in every adult presenting with diabetes.

Image source: David Leslie et al, 2021. Image shows the roadmap to better understand, diagnose and care for adults with T1D.


The full article is available from Diabetes Care [paper]

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

NHS England: More people with diabetes set to benefit from blood sugar monitors as NHS roll-out succeeds

NHS England | November 2021 | More people with diabetes set to benefit from blood sugar monitors as NHS roll-out succeeds

Half of NHS Type 1 diabetes patients in England are now benefiting from the use of “life-changing” flash monitors that allow them to check their glucose levels more easily and regularly, paving the way for more people to benefit.

Health service chief executive Amanda Pritchard, patient groups and senior clinicians have welcomed the milestone, showing that the NHS is ahead of target to roll-out the monitors, as the independent health advisory NICE, confirmed it was beginning to consult on expanding access to the convenient and effective kit.

The most recent figures show that around 125,000, or half, of patients living with Type 1 diabetes are now using these monitors to help control their condition.

The insight from the successful roll-out by NHS England has helped to inform the case for potential wider use of these technologies to benefit patients living with Type 1 diabetes, and potentially those living with Type 2 diabetes, as the health service continues to improve care for people with both forms of the condition.

The NHS Long Term Plan included a target to ensure 20 per cent of people with Type 1 diabetes were benefiting from flash monitors by March 2021.

Data for March shows the NHS significantly exceeded that goal, with the actual percentage of those benefiting hitting more than 45 per cent – double the target, with uptake by July hitting half of eligible people.

Eligible patients are currently able to access the monitors on prescription from their local GP or diabetes team, helping them to better manage their blood sugar levels.

The wearable gadgets have a sensor that easily attaches to the back of the arm, allowing patients to check their glucose quickly and easily with a simple one-second scan.

The monitors link to an easy-to-use app on your phone, where patients can access the data gathered by the device.

Unlike conventional blood glucose monitors they allow you to view patterns over time, not only showing current and previous levels but also where they’re headed (Source: NHS England).

More people with diabetes set to benefit from blood sugar monitors as NHS roll-out succeeds

Annual diabetes care processes and mortality using data from the National Diabetes Audit

Holman, N. et al | 2021 | Completion of annual diabetes care processes and mortality: A cohort study using the National Diabetes Audit for England and Wales | Diabetes Obesity & Metabolism | https://doi.org/10.1111/dom.14528

In England and Wales, the National Diabetes Audit (NDA) collects patient-level data on people with diagnosed diabetes. The present study assesses whether recorded care processes completion was associated with mortality over the subsequent decade after adjustment for the risk factors that the care processes uncover, individual demographic characteristics and comorbidities. This resulting paper, published in the journal Diabetes, Obesity & Metabolism highlights that individuals with diabetes who have fewer routine care processes have higher mortality.

Abstract

Aim

To conduct an analysis to assess whether the completion of recommended diabetes care processes (glycated haemoglobin [HbA1c], creatinine, cholesterol, blood pressure, body mass index [BMI], smoking habit, urinary albumin, retinal and foot examinations) at least annually is associated with mortality.

Materials and methods

A cohort from the National Diabetes Audit of England and Wales comprising 179 105 people with type 1 and 1 397 790 people with type 2 diabetes, aged 17 to 99 years on January 1, 2009, diagnosed before January 1, 2009 and alive on April 1, 2013 was followed to December 31, 2019. Cox proportional hazards models adjusting for demographic characteristics, smoking, HbA1c, blood pressure, serum cholesterol, BMI, duration of diagnosis, estimated glomerular filtration rate, prior myocardial infarction, stroke, heart failure, respiratory disease and cancer, were used to investigate whether care processes recorded January 1, 2009 to March 31, 2010 were associated with subsequent mortality.

Results

Over a mean follow-up of 7.5 and 7.0 years there were 26 915 and 388 093 deaths in people with type 1 and type 2 diabetes, respectively. Completion of five or fewer, compared to eight, care processes (retinal screening not included as data were not reliable) had a mortality hazard ratio (HR) of 1.37 (95 Over a mean follow-up of 7.5 and 7.0 years there were 26 915 and 388 093 deaths in people with type 1 and type 2 diabetes, respectively. Completion of five or fewer, compared to eight, care processes (retinal screening not included as data were not reliable) had a mortality hazard ratio (HR) of 1.37 (95 per cent confidence interval [CI] 1.28-1.46) in people with type 1 and 1.32 (95 per cent CI 1.30-1.35) in people with type 2 diabetes. The HR was higher for respiratory disease deaths and lower in South Asian ethnic groups. confidence interval [CI] 1.28-1.46) in people with type 1 and 1.32 (95 per cent CI 1.30-1.35) in people with type 2 diabetes. The HR was higher for respiratory disease deaths and lower in South Asian ethnic groups.

Conclusions

People with diabetes who have fewer routine care processes have higher mortality. Further research is required into whether different approaches to care might improve outcomes for this high-risk group.

Completion of annual diabetes care processes and mortality: A cohort study using the National Diabetes Audit for England and Wales [paper]

Scotland to rollout diabetes test for Type 1 patients

via BBC News | 31 October 2021 | Scotland to rollout diabetes test for Type 1 patients

Misdiagnosed Type 1 diabetes patients could be freed from the need to take insulin after a new test is rolled out.

Scotland will become the first country to offer the C-peptide blood test to all patients who have had a Type 1 diagnosis for at least three years.

The test shows how much insulin a patient’s body is producing itself. A pilot by NHS Lothian allowed some people who had been taking insulin to stop or reduce the treatment. The test will be available from 1 November.

C-peptide testing, which has been used as part of diagnosis for some patients for many years, can help distinguish whether a patient has Type 1 or Type 2 diabetes.

BBC News Scotland to rollout diabetes test for Type 1 patients

National Pregnancy in Diabetes Audit Report 2020

Health Quality Improvement Partnership | October 2021 | National Pregnancy in Diabetes Audit Report 2021

The National Pregnancy in Diabetes Audit measures the quality of antenatal care and pregnancy outcomes for women with pre-gestational diabetes. HQIP has published its report for 2020.

Key findings from the audit report:

There are now more pregnancies in women with type 2 diabetes, than in women with type 1 diabetes (54 per cent of diabetes’ pregnancies, compared to 47 per cent in 2014).

Women with type 2 diabetes face additional healthcare inequalities and are frequently not prepared for pregnancy (reduced use of insulin and folic acid before pregnancy), and

Despite the additional challenges of supporting women with diabetes during the COVID-19 pandemic, pregnancy outcomes are comparable in 2019 and 2020.

Image source: HQIP The first mage shows a sonographer, ultrasound and an expectant couple. The second shows a pregnant women preparing a selection of healthy foods

The report makes three recommendations

  1. Dedicated pre-pregnancy co-ordinators focused on enhanced provision of contraception and support for pregnancy preparation are recommended to improve glycaemic management and 5mg folic acid supplementation before pregnancy, especially in women with type 1 and type 2 diabetes, living in the most deprived regions.
  2. We found fewer preterm births, large for gestational age (LGA) birthweight, neonatal care admissions and perinatal deaths in women with HbA1c less than 43mmol/mol from 24 weeks gestation, both in the current 2019-2020 and recent datasets*. NICE guidelines [NG3 Diabetes in pregnancy: management from preconception to the postnatal period], recommend use of continuous glucose monitoring (CGM) in type 1 diabetes. Data are now needed to evaluate whether Libre or CGM use will improve glucose levels, target HbA1c attainment and neonatal health outcomes in pregnant women with type 2 diabetes.
  3. Access to structured education, weight management and diabetes prevention programmes for women (Source: HQIP).

National Pregnancy in Diabetes (NPID) Audit Report 2020

Glycaemic control during the lockdown for COVID-19 in adults with type 1 diabetes #Covid19RftLks

Garofolo, M. et al | 2021| Glycaemic control during the lockdown for COVID-19 in adults with type 1 diabetes: A meta-analysis of observational studies | Diabetes Research and Clinical Practice | doi: https://doi.org/10.1016/j.diabres.
2021.109066

This review is available online ahead of print. It updates an earlier systematic systematic review and meta-analysis of studies assessing the effects of lockdown during COVID-19 pandemic on glucose metrics in adult subjects
with type 1 diabetes using continuous glucose monitoring (CGM) and flash glucose monitoring (FGM).

The reviewers report that in their meta-analysis of aggregate data shows that well-controlled people with type 1
diabetes on both MDI and CSII with continuous or flash glucose monitoring did not experience a 14 deterioration in glucose control throughout the COVID-19 lockdown, showing a modest, though statistically significant improvement in many glucose control parameters (Garofolo et al, 2021).

Abstract

Aims:

To assess the effects of lockdown due to COVID-19 pandemic on glucose metrics, measured by glucose monitoring systems, in adult individuals with type 1 diabetes.

Methods: We conducted a systematic literature search for English language articles from MEDLINE, Scopus and Web of Science up to February 28, 2021, using “diabetes”, “lockdown”, and “glucose” as key search terms. Time in range (TIR) was the main outcome; other metrics were time above range (TAR), time below range (TBR), mean blood glucose (MBG) and its variability ( per cent CV), estimated HbA1c (eA1c) or glucose management indicator (GMI).

Results: Seventeen studies for a total of 3,441 individuals with type 1 diabetes were included in the analysis. In the lockdown period, TIR 70-180 mg/dl increased by 3.05 per cent declined by 3.39 per cent (-5.14 to -1.63 per cent ) and 1.96 per cent (-2.51 to -1.42 per cent ), respectively (p less than 0.0001 for both). Both TBR less than 70 and less than 54 mg/dL remained unchanged. MBG slightly decreased by 5.40 mg/dL (-7.29 to – 3.51 mg/dL; p less than 0.0001) along with a reduction in per centCV. Pooled eA1c and GMI decreased by 0.18 per cent (-0.24 to -0.11 per cent ; p less than 0.0001) and a similar reduction was observed when GMI alone was considered (0.15 per cent, -0.23 to – 0.07 per cent; p less than 0.0001). Sensor use was only slightly but not significantly reduced during lockdown.

Conclusions: This meta-analysis shows that well-controlled people with type 1 diabetes on both MDI and CSII with continuous or flash glucose monitoring did not experience a deterioration in glucose control throughout the COVID-19 lockdown, showing a modest, though statistically significant improvement in many glucose control parameters.

Glycaemic control during the lockdown for COVID-19 in adults with type 1 diabetes: A meta-analysis of observational studies [paper ahead of print]

Mindfulness in Relation to Diet Quality in Adults with Type 1 and Type 2 Diabetes: Results from Diabetes MILES-The Netherlands

Liu, S. et al | 2021| Mindfulness in Relation to Diet Quality in Adults with Type 1 and Type 2 Diabetes: Results from Diabetes MILES-The Netherlands| Mindfulness | https://doi.org/10.1007/s12671-021-01754-x

The objective of this research was to investigate the associations between dispositional mindfulness and diet quality in Dutch adults with type 1 diabetes (T1DM) or type 2 diabetes (T2DM). They hypothesized that a higher level of mindfulness is related to greater diet quality. In the light of previous research in other populations (Sala et al., 2020), they theorised that each mindfulness facet is positively associated with diet quality. In addition, they evaluated the potential mediating role of emotional distress in these associations.

The researchers found that a higher level of dispositional mindfulness and a higher score on observing were associated with higher diet quality. The results were more robust in people with T1DM. Their findings also suggest that overall mindfulness and the facet of observing are associated with higher diet quality in people with diabetes, independent of emotional distress.

They conclude that their findings suggest that mindfulness, especially observing facet, may relate to a healthier diet in adults with diabetes (Source: Liu et al, 2021).

The full paper is available to read from Mindfulness