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.
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, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, <70 mg per deciliter). Safety was assessed.
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%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval CI, 7.4 to 9.9) higher during the closed-loop period than during the control period (P<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% CI, -9.9 to -7.1), the difference in the glycated hemoglobin level was -0.4 percentage points (95% CI, -0.5 to -0.3), and the difference in the mean sensor glucose level was -12.3 mg per deciliter (95% CI, -14.8 to -9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P = 0.74). The median time spent in the closed-loop mode was 95% (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.
A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT03784027.).
With the evolution of diabetes technology, those living with Type 1 diabetes are given a wider arsenal of tools with which to achieve glycaemic control and improve patient‐reported outcomes. ...Furthermore, the use of these technologies may help reduce the risk of acute complications, such as severe hypoglycaemia and diabetic ketoacidosis, as well as long‐term macro‐ and microvascular complications. In addition, diabetes technology can have a beneficial impact on psychosocial health by reducing the burden of diabetes. Unfortunately, diabetes goals are often unmet and people with Type 1 diabetes too frequently experience acute and long‐term complications of this condition, in addition to often having less than ideal psychosocial outcomes. Increasing realization of the importance of patient‐reported outcomes is leading to diabetes care delivery becoming more patient‐centred. Diabetes technology in the form of medical devices, digital health and big data analytics have the potential to improve clinical care and psychosocial support, resulting in lower rates of acute and chronic complications, decreased burden of diabetes care, and improved quality of life.
What's new?
Diabetes technology presents the potential to make diabetes care more patient‐centric, improve care, and reduce current and future complications of diabetes.
Optimal diabetes management requires both the medical and psychosocial needs of people with Type 1 diabetes and their caregivers to be addressed. Diabetes technology will play an increasing role in the future of diabetes care.
The aim of this paper was to demonstrate how, by incorporating technology into diabetes care, we can increase patient‐centered care, reduce acute and chronic diabetes complications, and improve clinical outcomes and quality of life.
Objective To examine the prevalence of anxiety symptoms and their association with blood glucose monitoring (BGM) and glycemic control in adolescents with type 1 diabetes. Methods 276 adolescents and ...their caregivers completed measures of anxiety symptoms. Adolescents completed a measure of depressive symptoms. Demographic and family characteristics were obtained from caregiver report. Diabetes duration, regimen type, BGM frequency, and glycemic control were also collected. Results Trait anxiety symptoms that suggest further clinical assessment is needed were present in 17% of adolescents; the rate was 13% for state anxiety symptoms. Higher levels of state anxiety symptoms were associated with less frequent BGM F(14, 261) = 6.35, p < .0001, R2 = .25, and suboptimal glycemic control, F(15, 260) = 7.97, p < .0001, R2 = .32. State anxiety symptoms were correlates of BGM frequency and glycemic control independent of depressive symptoms. Conclusions State anxiety symptoms are associated with less frequent BGM and suboptimal glycemic control in adolescents with type 1 diabetes.
Aim
Participants in clinical trials assessing automated insulin delivery systems report perceived benefits and burdens that reflect their experiences and may predict their likelihood of uptake and ...continued use of this novel technology. Despite the importance of understanding their perspectives, there are no available validated and reliable measures assessing the psychosocial aspects of automated insulin delivery systems. The present study assesses the initial psychometric properties of the INSPIRE measures, which were developed for youth and adults with Type 1 diabetes, as well as parents and partners.
Methods
Data from 292 youth, 159 adults, 150 parents of youth and 149 partners of individuals recruited from the Type 1 Diabetes Exchange Registry were analysed. Participants completed INSPIRE questionnaires and measures of quality of life, fear of hypoglycaemia, diabetes distress, glucose monitoring satisfaction. Exploratory factor analysis assessed factor structures. Associations between INSPIRE scores and other measures, HbA1c, and technology use assessed concurrent and discriminant validity.
Results
Youth, adult, parent and partner measures assess positive expectancies of automated insulin delivery systems. Measures range from 17 to 22 items and are reliable (α = 0.95–0.97). Youth, adult and parent measures are unidimensional; the partner measure has a two‐factor structure (perceptions of impact on partners versus the person with diabetes). Measures showed concurrent and discriminant validity.
Conclusions
INSPIRE measures assessing the positive expectancies of automated insulin delivery systems for youth, adults, parents and partners have meaningful factor structures and are internally consistent. The developmentally sensitive INSPIRE measures offer added value as clinical trials test newer systems, systems become commercially available and clinicians initiate using these systems.
What's new?
Participants in clinical trials of automated insulin delivery systems report perceived benefits and burdens of these systems. It is not yet known if these perceptions predict their likelihood of uptake and continued use.
Currently, there are no available validated and reliable measures assessing the psychosocial aspects of automated insulin delivery systems.
This study adds to the current science by providing an essential ingredient in the ongoing assessment of automated insulin delivery systems. Specifically, it offers information regarding the initial psychometric properties of the INSPIRE measures, a developmentally sensitive suite of measures for youth, adults, parents and partners.
The measures assess the positive expectancies of users. The measures can support clinical practice by providing important insights into the onboarding and support needs of persons transitioning to these novel systems.
Summary
Background
Symptoms compatible with irritable bowel syndrome (IBS) are frequently present in patients with inflammatory bowel disease (IBD); however, the cause of this phenomenon is unclear.
...Aim
To determine the different contributions of ‘true IBS’ and sub‐clinical inflammation in producing IBS‐type symptoms in IBD patients, and to ascertain the impact these symptoms have on the clinical assessment of IBD activity.
Methods
In this cross‐sectional study, 169 IBD patients completed questionnaires to assess disease activity, presence of IBS‐type symptoms, and levels of anxiety and depression. Stool samples were collected for analysis of faecal calprotectin (FC).
Results
IBS‐type symptoms were significantly more common in female patients (OR = 4.64, 1.55–13.88) and were associated with higher levels of anxiety (OR = 1.11, 1.01–1.21). There was no statistical difference between the FC levels of patients in clinical remission with IBS‐type symptoms compared with those without (median values = 111 μg/g vs. 45.5 μg/g respectively, P = 0.171). The prevalence of IBS‐type symptoms in patients with a normal FC level was 31%.
Conclusions
A substantial number of IBD patients with normal faecal calprotectin level experience IBS‐type symptoms. These patients exhibit similar features to people diagnosed with IBS in the general community, suggesting that the conditions are not mutually exclusive and may coexist in a considerable number of IBD patients. A systematic diagnostic approach is required to assess IBD patients with IBS‐type symptoms as sub‐clinical inflammation may play a role in a proportion of cases.
Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. We hypothesized that early fibrinogen replacement, guided by viscoelastometric testing, reduces blood product usage and bleed ...size.
Women with PPH 1000–1500 ml were enrolled. If Fibtem A5 was ≤15 mm and bleeding continued, subjects were randomized to fibrinogen concentrate or placebo. The primary outcome compared the number of units of red blood cells, plasma, cryoprecipitate and platelets transfused.
Of 663 women enrolled 55 were randomized. The adjusted incidence rate ratio (IRR) (95% CI) for the number of allogeneic units transfused in the fibrinogen group compared with placebo was 0.72 (0.3–1.7), P=0.45. In pre-specified subgroup analyses, subjects who had a Fibtem A5 ≤12 mm at the time of randomization and who received fibrinogen concentrate received a median (25th–75th centile) of 1 (0–4.5) unit of allogeneic blood products and had an additional 300 (100–350) ml blood loss whereas those who received placebo also received 3 (0–6) units of allogeneic blood products and had 700 (200–1550) ml additional blood loss; these differences were not statistically significantly different. There was one thrombotic event in each group.
Infusion of fibrinogen concentrate triggered by Fibtem A5 ≤15 mm did not improve outcomes in PPH. Pre-specified subgroup analyses suggest that fibrinogen replacement is not required if the Fibtem A5 is > 12 mm or Clauss fibrinogen >2 g litre−1, but an effect below these levels cannot be excluded. The raised fibrinogen at term appears to be a physiological buffer rather than required for haemostasis.
ISRCTN46295339 (http://www.isrctn.com/ISRCTN46295339, last accessed 5 July 2017), EudraCT 2012-005511-11 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005511-11, last accessed 5 July 2017).
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