Active clinical trials for "Diabetes Mellitus"

An observational study of electronic patient data to compare diabetes medications and to determine which ones offer the best balance of risks and benefits.

The purpose of this single center observational study is to determine the effect of continuous remote continuous glucose monitor (CGM) reporting coupled with a telemedicine intervention (Tele-CGM program) on levels of HbA1C in adults with poorly controlled type 1 or type 2 diabetes. The investigators will follow 200 English and Spanish speaking adults (125 type 2 and 75 type 1 patients) who have an HbA1C >8% over 12 months. The primary analysis will follow the intention-to-treat principle; participants will all be offered the intervention. The primary trial outcome of HbA1c/Glucose Management Indicator (GMI) at 6 and 12 months will be compared from baseline using a linear regression model. The primary independent variable will be the HbA1C from baseline to 6 and 12 months. Patients will serve as their own control. Results will be summarized as group-specific mean, standard deviation (SD) HbA1c, along with a mean treatment difference and 95% confidence interval. Model assumptions including normality and homoscedasticity of residuals will be evaluated; normalizing transformations or rank-based non-parametric procedures will be used as needed. The complete evaluation of HbA1c, including baseline, 6-month and 12 month measurements will be analyzed with mixed effects linear regression, specifying a random participant-level intercept and an unstructured covariance matrix, to accommodate the repeatedly measured data. The secondary trial outcomes of time in range (TIR; CGM glucose levels 70-180) and questionnaires will be compared from baseline to 6 and 12 months using linear regression procedures as detailed above.

The aim of this study is to investigate the efficacy，safety， and tolerability of the recombinant human insulin patch ZJSRM2021 in healthy subjects, type 1diabetes mellitus and type 2diabetes mellitus patients

Treatment of Type 1 diabetes requires daily insulin therapy given by either multiple daily injections or by continuous infusion via a pump. The insulin dose is calculated taking into consideration blood glucose levels, food intake and activity levels, aiming to avoid high and low readings. The Tandem t:slim X2™ insulin pump has recently become available in NHS Scotland and can link with the Dexcom G6 continuous glucose monitoring (CGM) system. The Tandem Control IQ hybrid closed loop system is made up of the Tandem insulin pump communicating wirelessly with the Dexcom G6 CGM. The algorithm within the pump then automatically controls the background (basal) insulin infusion rate. Manually delivered bolus insulin is still required for meals. This system is designed to finely tune insulin delivery and increase the amount of time that glucose is in the target range, reducing hypoglycaemia and hyperglycaemia. Insulin pumps are funded by NHS Scotland, but the Dexcom G6 continuous glucose monitoring system is not, so this hybrid closed loop system is not currently routinely available in NHS Scotland. The purpose of this study is to gain experience of this system and investigate how effective and acceptable the hybrid closed loop system is for people in Scotland. Participants will be provided with the Dexcom G6 CGM device to link to their current pump to create the hybrid closed loop system for the duration of the study. 30 people with Type 1 diabetes who have been using the Tandem pump for at least one month will be invited to participate. The study will include a screening visit, a 30 day run-in period, 52 week treatment period and 12 week follow-up period. Diabetes control will be measured using HbA1c and downloaded information from the hybrid closed loop system. Participants will also complete questionnaires and a reflective diary.

This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.

XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations.

The aim of this study is to assess the levels of neuregulin-4 and its receptor ErbB4 in the GCF and saliva in stage III and IV periodontitis patients with and without type 2 diabetes mellitus.

Gestational diabetes mellitus (GDM) can lead to adverse perinatal and long-term outcomes, and it is so important to manage this disease in pregnancy. Digitalized managements have been proved economical and effective in some chronic diseases like type II diabetes mellitus. The purpose of the current study was to develop and evaluate a digitalized mode for GDM management using mobile healthcare and some wearable devices. Subjects were randomly divided into a conventional management group and combined digitalized management group after diagnosed with GDM during 24-28 weeks of gestation. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received digitalized healthcare services from artificial intelligence under the supervision of obstetricians, in addition to conventional management. The effectiveness of digitalized management were evaluated mainly through the result values of the labotatory tests related to blood glucose controlling and perinatal outcomes.

Early diabetic kidney disease (DKD) occurs in 50-70% of youth with type 2 diabetes (T2D) and confers high lifetime risk of dialysis and premature death. Youth-onset T2D typically manifests during or shortly after puberty in adolescents with obesity. Epidemiological data implicate puberty as an accelerator of kidney disease in youth with obesity and diabetes and the investigators posit that the link between puberty and T2D-onset may explain the high burden of DKD in youth-onset T2D. A better understanding of the impact of puberty on kidney health is needed to promote preservation of native kidney function, especially in youth with T2D. Puberty is a complex process of physiological changes, including neuroreproductive and growth hormone activation and rapid organ growth, that may predispose organs to injury. The kidneys may be especially susceptible because they are highly metabolically active and second only to the heart with respect to oxygen consumption per tissue mass. During puberty, the kidneys almost double in size, likely increasing the kidneys' already high energy expenditure. In parallel, puberty is associated with physiologic insulin resistance (IR), which is accentuated in obesity. Our central hypothesis is that obese youth with prediabetes and T2D experience relative kidney hypoxia during puberty due to a metabolic mismatch between increased energy expenditure and impaired substrate metabolism. In turn, the kidney hypoxia results in loss of glomerular charge and size selectivity leading to increased transglomerular transport of protein and kidney dysfunction. Our preliminary data showed that pubertal adolescents with obesity and/or diabetes exhibit relative kidney hypoxia compared to normal weight controls using functional magnetic resonance imaging (MRI) and that relative kidney hypoxia is greater in late vs. early puberty. However, determining the pubertal mechanisms contributing to kidney injury in youth with obesity and T2D requires serial evaluations throughout puberty. To assess the impact of pubertal changes within a 5-year study period, the investigators propose an accelerated longitudinal study design in which the investigators will enroll adolescents (8-14 years, 50% girls) with obesity and elevated hemoglobin A1c (HbA1c ≥6%) [n=60], and healthy normal weight controls [n=40] at Tanner (pubertal) stages 1-4 and examine them at baseline, 1 and 2-years. The investigators will then compare data by Tanner stage to construct an integrated portrayal of the physiological changes that occur throughout puberty. Given the rarity of T2D prior to pubertal onset, the investigators chose to enroll a high high-risk group: youth with obesity and HbA1c ≥6.0% to represent youth ranging from those at magnified risk of developing T2D to those recently diagnosed.