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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT05548699 Recruiting - Diabetes Mellitus Clinical Trials

Precision Mental Health in Diabetes - Subtypes of Mental Health, Trajectories, and Patterns With Glycaemic Control

PRO-MENTAL
Start date: May 2, 2023
Phase:
Study type: Observational

PRO-MENTAL is a non-interventional, prospective, observational study investigating longitudinal associations between diabetes distress, mental disorders, and glycemic outcomes in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). The study aims to determine mental health subtypes, trajectories, and patterns and to advance a precision medicine approach to improve mental health in people with diabetes through personalized care and interventions. A total of 1500 people with T1D or T2D will participate in the study, running over a 24-month period. Participants will be recruited at different levels of diabetes care including specialized centers and hospitals. The assessment includes a baseline assessment (clinical interview, questionnaire survey, and laboratory assessment) and four subsequent measurement time points - every six months - to a total period of two years. Each measurement time point includes an online questionnaire survey as well as a 14-day ambulatory assessment of daily mental and somatic variables (smartphone-based ecological momentary assessment (EMA) of daily sleep quality, mood, stress, and diabetes-related burdens/distress, as well as continuous glucose measurement (CGM) of daily glucose levels). The study uses precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcome. Epidemiological data regarding prevalence and incidence rates of depression, anxiety, and eating disorders will be analyzed, and patient trajectories and patterns will be determined. The study also aims to shed more light on the mediating mechanisms between mental health and glycemic outcomes. The findings of the study will be used as the basis to develop a precision medicine approach with personalized interventions for specific sub-groups of people with type 1 and type 2 diabetes.

NCT ID: NCT05548205 Not yet recruiting - Diabetes Clinical Trials

Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.

NCT ID: NCT05545722 Completed - Diabetes Mellitus Clinical Trials

The Effect of Life Coaching With Diabetes on Glycemic Control, Strengthening Diabetes and Self-management

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Diabetes Mellitus (DM) is an endocrine and metabolic disease that is characterized by hyperglycemia, develops microvascular and macrovascular complications, and requires chronic and continuous care. is a disease. According to IDF 2019 data, it is predicted that the number of diabetics in the world, which was 463 million in 2019, will reach 700 million in 2045 with an increase of 51%. The global prevalence of diabetes between the ages of 20-79 in 2019 is 9.3%, and it is estimated to increase to 10.2% in 2030 and 10.9% in 2045. Our country, on the other hand, has the highest prevalence with a rate of 11.1% among European countries. According to the IDF 2019 Diabetes Atlas data, 6.6 million people with diabetes live in our country as of 2019, and it is estimated that this rate will reach 10 million by 2045. American Diabetes Association (American Diabetes Association) and American Association of Clinical Endocrinologists (American Association of Clinical Endocrinologists) to achieve the goals of treatment and care in individuals with diabetes; emphasizes the need for regulation of nutrition, regulation of physical activity, regulation of pharmacological treatment, diabetes education, continuous monitoring and health controls. Individuals with diabetes should receive diabetes self-management education and support when necessary. Diabetes self-management is defined as the process of facilitating the knowledge, skills and abilities necessary for the individual's self-care. Individuals with diabetes who are competent and skilled in self-management can improve their health outcomes. The American Diabetes Association (ADA) defines diabetes self-management education as a process that begins at the diagnosis stage and continues, based on an individual-centered approach and making joint decisions to facilitate the knowledge, skills and abilities necessary for the self-care of diabetes patients. The purpose of diabetes self-management is for diabetics to develop new skills and behaviors that support self-management goals, and to form habits. The general goals of diabetes self-management education are to support individuals diagnosed with diabetes to make conscious decisions, solve problems, perform self-care behaviors, and improve their metabolic results, health status and quality of life. Diabetes patients need knowledge, skills and motivation to strengthen their diabetes by providing self-management. The nurse helps the patient to adapt to the disease and achieve the ability to perform self-care by counseling and training individuals. Coaching sessions are used to strengthen self-management and diabetes in diabetes. The coach is the person who provides the necessary motivation to maximize the strengths of the client, to ensure that the potentials are fully used through continuous education, to develop new skills and activities to be more effective, to be ready for new responsibilities and to manage himself. Life Coaching with Diabetes is based on the basic principles and principles of professional life coaching practices (ICF-International Coaching Federation), aiming at behavioral change in approaches related to diabetes lifestyle. Life coaching with diabetes is to give practical applications to people who have been diagnosed with diabetes in order to gain necessary changes in life through coaching. 2. Problem and Sub-Problems H0: Diabetes life coaching given to individuals with Type 2 Diabetes has no effect on glycemic control, diabetes strengthening and self-management. H1: Diabetes life coaching given to individuals with Type 2 Diabetes has an effect on glycemic control, strengthening diabetes and self-management. 3. Aims and Expected Benefits of the Research This study was planned as a control group intervention study to determine the effect of diabetes coaching on glycemic control, diabetes strengthening and self-management in individuals with Type 2 Diabetes. Expected benefits: - Developing appropriate self-care activities (physical activity, medical nutrition, drug management, avoiding risky behaviors, etc.) by improving the self-management skills of the individual with diabetes, - Individuals with diabetes become self-managed in their self-care practices, - Ensuring metabolic control of the diabetic individual - Developing decision-making and problem-solving skills of individuals with diabetes, - Promoting diabetes coaching in the nursing profession and increasing its visibility and spreading diabetes coaching.

NCT ID: NCT05544643 Completed - Clinical trials for Diabetes Mellitus, Type 1

Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set

Start date: August 4, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the Extended Mio 30 infusion set (EM30IS) 7-day functioning compared to the regular Mio 30 infusion set (M30IS) 3-day functioning. The study will be carried out in adult patients with type 1 diabetes. Secondary objective, to evaluate the differences in glucose control between the infusion set currently used by participants (Medtronic Quick set infusion sets) and the Medtronic Mio 30 Infusion Set.

NCT ID: NCT05544435 Completed - Clinical trials for Diabetes Mellitus, Type 2

Motivational Interviewing on Self-Care Activities in T2DM: The Sample of Turkey

Start date: September 25, 2019
Phase: N/A
Study type: Interventional

Purpose:This study aims to research the effects of motivational interviewing on self-care activities in patients with type 2 diabetes. Design and Method:This study is a quasi-experimental clinical research with pre-test post-test comparison.12 sessions were held in 3 months in the experimental group with motivational interviewing method. Findings:After a 3-month follow up, while a significant improvement was observed in post-intervention self-care activities in the experimental group, a significant decrease was observed in all self-care activities except foot care in the control group. Practice Implications:Motivational interviewing intervention can be used to develop self-care activities in type 2 diabetes patients, especially to guide diabetes nurses.

NCT ID: NCT05544266 Recruiting - Diabetes Mellitus Clinical Trials

Rare and Atypical Diabetes Network

RADIANT
Start date: September 30, 2020
Phase:
Study type: Observational

RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes. The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to: 1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes. 2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes. 3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.

NCT ID: NCT05543850 Completed - Clinical trials for Diabetes Mellitus, Type 1

Portable Artificial Pancreas Applied for Youth and Adolescents

PAPAYA 1
Start date: October 28, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current treatment of the patients. Also, safety parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment satisfaction scores) are compared. This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will be randomized to receive either the open-loop therapy or the closed-loop therapy for the first two-week study period and switch to the alternate treatment with at least two weeks in between.

NCT ID: NCT05543720 Recruiting - Hypertension Clinical Trials

Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

In Canada, 3 out of 4 Canadians aged 65 and older have at least one chronic condition, while 1 in 4 seniors reported having three or more. Caring for complex patients who usually have multiple chronic conditions (MCC) is one of the biggest challenges facing our healthcare system. For patients, the lack of coordination and continuity of care as they transfer between healthcare settings and healthcare providers (HCPs) often results in a higher risk of readmission, suboptimal and fragmented care plans, delays in required medical intervention, inadequate self-care, and confusion on whom they should contact when they have questions. For the patient's care team, they often have no indication how patients are doing between clinic visits unless the patient can provide a log of their home measurements (e.g., blood pressure). Therefore, they are unable to detect and intervene if their patient's health is worsening between visits. In order to address this increasing need to bridge the current gap in clinical management and self-care of complex patients during their transition from healthcare settings to home care, our team aims to design, implement and evaluate the SMaRT (Safe, Managed, and Responsive Transitions) Clinic, a nurse-led integrated care model facilitated by telemonitoring (TM). Specifically, the SMaRT Clinics aim to meaningfully introduce a nurse (or nurse practitioner) role to improve clinical coordination across patient care teams and reinforce proper self-care education through the use of telemonitoring. This project will be conducted in two phases across four years; Phase I: Design and Development, and Phase II: Implementation and Effectiveness Evaluation. Phase II research activities include enrolling 350 patients with complex chronic conditions in the SMaRT clinics across four study sites. The implementation and effectiveness of the SMaRT clinics will be evaluated through a mix of semi-structured interviews, ethnographic observation, patient questionnaires, and analyses of health utilization outcomes using propensity-matched controls from the ICES provincial database.

NCT ID: NCT05543564 Completed - Diabetes Clinical Trials

Prophylactic PRP in Moderate NPDR

Start date: February 1, 2019
Phase:
Study type: Observational

Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR) provided careful follow-up can be maintained,. When retinopathy is more severe, scatter photocoagulation should be considered and should not be delayed if the eye has reached the high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal, good as it is, is not what ophthalmic practice has to deal with in communities of low-resource settings, where patients often seek medical advice due to visual complaints from the complications of PDR without being diagnosed in the non-proliferative stage or high risk PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic lockdown.

NCT ID: NCT05543265 Active, not recruiting - Obesity Clinical Trials

Bridging the Gap From Postpartum to Primary Care

Start date: November 3, 2022
Phase: N/A
Study type: Interventional

Chronic health conditions affect most older adults. Preventative medicine and risk management strategies, especially when applied earlier in life, are essential to altering the trajectory of a disease and ultimately improving health outcomes. Primary care providers (PCP) often provide most of these services, though younger adults are the least likely to receive primary care. This project leverages a period of high engagement and health activation during an individual's life (pregnancy) to nudge her toward use of primary care after the pregnancy episode. This randomized controlled trial will test the hypothesis that a behavioral science-informed intervention, incorporating defaults and salience, can increase the rates of PCP follow-up within 4 months following a delivery for individual with hypertension, diabetes, obesity. If successful, this intervention could serve as a scalable solution to increase primary care use and preventative health services in a population that currently has low rates of engagement and utilization of these services.