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T1DM clinical trials

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NCT ID: NCT04421001 Not yet recruiting - T1DM Clinical Trials

RCT for Evaluation of Insulin Administration,While Using the iPORT System

Start date: October 2020
Phase: N/A
Study type: Interventional

Type 1 diabetes is the most common chronic pediatric autoimmune disease, with a rising incidence rate in recent years around the world and in Israel Management includes multiple daily capillary glucose measurements by finger pricks, or interstitial sugar measurements by sensors, and insulin subcutaneous administration before each meal by injections or by an insulin pump . The initial management and teaching of T1D patients and families includes at least 5-6 glucose measurements per day and at least 4 insulin injections per day, while the preferred guideline should be insulin administration prior to each meal, including morning and afternoon snacks, very common among pediatric patients attending school curriculum. The early use of I-port at disease diagnosis may reduces pain, increase the amount of daily injections, may increase accuracy of insulin administration, and thus improve time in range from disease diagnosis. Aims of study: To assess the efficacy of I-port use in recent onset T1D in a pediatric population, in increasing insulin administration and possibly improving time in range of glucose.

NCT ID: NCT04054934 Not yet recruiting - ADHD Clinical Trials

Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes

Start date: January 2022
Phase:
Study type: Observational

Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. The goals of therapy are to achieve glycemic control (HbA1c < 7.5%), and minimal glycemic excursions. Furthermore, recent studies imply that keeping HbA1c within target range is not sufficient to prevent complications, attributed mainly to blood glucose level fluctuating from high to low, associated with food intake and adolescents behavior. The current implication of glycemic control on the central nervous system (CNS) includes abnormal electrical brain activity, structural changes in brain's white and grey matter, and cognitive impairment. Still, little is known on the effect of sleep pattern, including circadian rhythm reversal ("biological clock) on asymptomatic glycemic excursions, and on CNS functions. There is no data regarding the association of the biologic clock on CNS functionality among adolescents, nonetheless among T1DM adolescents, for whom behavior and circadian rhythm alterations may have harmful effect. The investigators propose a cross-over designed study by examining adolescents with and without T1DM during 2 weeks of regular sleeping pattern (night sleep), and during 2 weeks of sleeping during the day as happens during summer vacation. The main objective of the proposed study is to offer proof of the clinical and metabolic relevance and cognitive effects of the reversal of the circadian clock in adolescents with and T1DM during summer vacations and weekends. Study is designed to demonstrate a difference among healthy and diabetics during reversed night/day circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.