In two randomized trials conducted under home conditions, investigators compared closed-loop insulin delivery with sensor-augmented pump therapy in adults and in children and adolescents for 12 ...weeks. The closed-loop approach improved glucose control and reduced hypoglycemia.
Intensive insulin therapy is the standard of care for type 1 diabetes but is limited by the risk of hypoglycemia,
1
which leads to failure in achieving treatment goals for most patients in all age groups.
2
,
3
Among patients with type 1 diabetes, hypoglycemia is common, has a major effect on patients’ quality of life and psychological well-being,
4
and may cause seizures, which is of particular concern during the overnight hours in children and adolescents.
5
New approaches (e.g., continuous glucose monitoring) can improve glycemic control when the patient wears the sensors on a regular basis.
6
,
7
If insulin delivery is linked . . .
To evaluate the impact of CamAPS FX hybrid closed-loop (HCL) automated insulin delivery in very young children with type 1 diabetes (T1D) on caregivers' well-being, fear of hypoglycemia, and ...sleepiness.
We conducted a multinational, open-label, randomized crossover study. Children (age 1-7 years) with T1D received treatment for two 4-month periods in random order, comparing HCL with sensor augmented pump (control). At baseline and after each treatment period, caregivers were invited to complete World Health Organization-Five Well-Being Index, Hypoglycemia Fear Survey, and Epworth Sleepiness Scale questionnaires.
Caregivers of 74 children (mean ± SD age 5 ± 2 years and baseline HbA1c 7.3 ± 0.7%; 42% female) participated. Results revealed significantly lower scores for hypoglycemia fear (P < 0.001) and higher scores for well-being (P < 0.001) after HCL treatment. A trend toward a reduction in sleepiness score was observed (P = 0.09).
Our results suggest better well-being and less hypoglycemia fear in caregivers of very young children with T1D on CamAPS FX HCL.
IntroductionDespite therapeutic advances, many individuals with type 1 diabetes are unable to achieve tight glycaemic target without increasing the risk of hypoglycaemia. The objective of this study ...is to determine the effectiveness of a 3-month day-and-night home closed-loop glucose control combined with a pump suspend feature, compared with sensor-augmented insulin pump therapy in youths and adults with suboptimally controlled type 1 diabetes.Methods and analysisThe study adopts an open-label, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design and aims for 84 randomised patients. Participants are youths (6–21 years) or adults (>21 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mol) and ≤10% (86 mmol/mol)). Following a 4-week run-in period, eligible participants will be randomised to a 3-month use of automated closed-loop insulin delivery combined with pump suspend feature or to sensor-augmented insulin pump therapy. Analyses will be conducted on an intention-to-treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3-month free-living phase. Secondary outcomes include HbA1c at 3 months, mean glucose, time spent below and above target; time with glucose levels <3.5 and <2.8 mmol/L; area under the curve when sensor glucose is <3.5 mmol/L, time with glucose levels >16.7 mmol/L, glucose variability; total, basal and bolus insulin dose and change in body weight. Participants’ and their families’ perception in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be evaluated.Ethics and disseminationEthics/institutional review board approval has been obtained. Before screening, all participants/guardians will be provided with oral and written information about the trial. The study will be disseminated by peer-reviewed publications and conference presentations.Trial registration numberNCT02523131; Pre-results.
The Leeds Children's Diabetes Service's approach to managing diabetes in schools, to help raise awareness and support children in multiple daily injection regimens, by an alliance between parents, ...teaching staff and health care professions, including the children's diabetes nurse specialist. (BNI unique abstract) 16 references
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is among the most widely used patient-reported outcome measures in cancer research and ...practice. It was developed prior to guidance that content should be established directly from patients to confirm it measures concepts of interest and is appropriate and comprehensive for the intended population. This study evaluated the content validity of the QLQ-C30 for use with cancer patients.
Adults undergoing cancer treatment in Europe and the USA participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side-effects and impacts on health-related quality of life. Thematic analysis was conducted, and similarities across cancer types, disease stages and countries or languages were explored.
Interviews with 113 patients with cancer (85 European, 28 USA) including breast, lung, prostate, colorectal and other cancers were conducted between 2016 and 2020. Conceptual saturation was achieved. The most frequently reported concepts were included in the QLQ-C30 conceptual framework. QLQ-C30 items were widely understood across language versions and were relevant to patients across cancer types and disease stages. While several new concepts were elicited such as difficulty climbing steps or stairs, weight loss, skin problems and numbness, many were not widely experienced and/or could be considered sub-concepts of existing concepts.
The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden and health-related quality of life in patients with localised-to-advanced cancer.
•European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 is widely used to measure quality of life in oncology.•Content validity is evidence that an instrument measures the concept of interest.•Measures should demonstrate content validity directly from patients.•This study demonstrates content validity across a broad range of cancers and stages.•The European Organisation for Research and Treatment of Cancer measurement model remains valid today for use in research.
Mechanism-based inhibitors of human cytomegalovirus (HCMV) protease have been designed based on the pyrrolidine-5,5-trans-lactam ring system. New routes to the β-methyl-, desmethyl-, and ...α-methyl-pyrrolidine-5,5-trans-lactam templates have been developed from 2,4-diaminobutyric acid. ESI/MS studies have shown that these inhibitors can bind covalently and reversibly to the viral enzyme in a time-dependent manner by a mechanism which is consistent with acylation of HCMV δAla protease at the active site nucleophile Ser 132. SAR in this series of pyrrolidine-5,5-trans-lactams has defined the relative stereochemisty of the methyl substituent adjacent to the lactam carbonyl, the functionality on the lactam nitrogen, and the mechanism of action of this novel series of serine protease inhibitors against the HCMV δAla protease. Activity decreases on moving from the α-methyl to the desmethyl to the β-methyl series. This selectivity is the opposite of that observed for these templates against the elastase and thrombin enzymes. The activity against HCMV δAla protease is the greatest with inhibitors based on the Cbz-protected α-methyl-5,5-trans-lactam template which have low micromolar activity against the viral enzyme.
PDF
