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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT05940376 Not yet recruiting - Diabetes Mellitus Clinical Trials

Topical Insulin in Neurotrophic Keratopathy After Diabetic Vitrectomy

Start date: July 15, 2023
Phase:
Study type: Observational

Various treatment options have been proposed in managing NK such as preservative-free lubrication (PF-L), withdrawal of epitheliotoxic medication, prophylactic antibiotics, applying of bandage contact lenses, using hemoderivatives 8, topical insulin, recombinant nerve growth factor (rNGF) or epidermal growth factor (rEGF).11,12, amniotic membrane transplant (AMT), or corneal neurotization.2,4,9,10 Topical insulin has been reported to effectively promote the healing of persistent corneal epithelial defects. In our retrospective study, we explored the safety and efficacy of topical insulin, as a first-line treatment, in treatment-naïve acute NK after diabetic vitrectomy.

NCT ID: NCT05939349 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People With Prediabetes and Type 2 Diabetes

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The goal of this project is to co-design a healthcare provider-based produce prescription program (PPR) in partnership with the community served to improve participants' food security status, diet quality, and cardio-metabolic health outcomes, and to reduce healthcare costs, specifically related to medication use and hospital visits. Novel to this study is an implementation of a community co-designed randomized controlled trial (RCT) with a delayed intervention control group focused of equity (i.e., including the target population in the intervention designed for them) in design, implementation, and evaluation. The project will be conducted in 3 phases. Phase 1 will involve formative research and PPR co-design with community partners and potential participants through listening sessions, partner meetings, and community advisory group sessions to finalize the intervention protocol and components, for which investigators will then request IRB approval. Phase 2 will involve the implementation of a delayed intervention RCT PPR. Data analysis and final reporting will be conducted during Phase 3. Specific Aims: In collaboration with community partners and community members, utilize implementation science strategies to identify and address community, systemic, and structural barriers and assets to co-design a tailored produce prescription program (PPR) intervention that emphasizes health equity in a low-income population served by Griffin Hospital (GH) and/or Griffin Faculty Physicians (GFP). Hypothesis: Collaborating with our community partners on the design and implementation of a PPR will lead to a successful design and implementation of the PPR to our population of focus, as evidenced by satisfaction, retention, experiences of dignity/respect, improved self-efficacy related to fruit and vegetable consumption, and diet quality. Demonstrate improvements, in intervention group vs delayed intervention control group, in food security status, diet quality, and cardio-metabolic outcomes in individuals with prediabetes or type 2 diabetes through implementation of a tailored PPR in a low-income population served by GH and/or GFP. Hypothesis: The PPR designed with community input will improve food security status, diet quality, self-reported health related quality of life and cardio-metabolic outcomes (Hemoglobin A1C, weight/body mass index, lipids, blood pressure), among our intervention participants compared with a control over a 6-month period. Evaluate the impact of a tailored PPR on healthcare cost among low-income participants with prediabetes or type 2 diabetes. Hypothesis: The successful implementation of the tailored PPR will lead to a reduction in certain healthcare cost specifically related to medication usage (including dose) and reduction in emergency department visit and/or hospitalization among intervention participants compared with a control over a 6-month period.

NCT ID: NCT05935839 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 1

Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

In this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by MSOT and compared with existing methods (ABI testing, neurological testing) (method comparison). The aim is to quantify changes and to possibly allow early detection of concomitant diseases. This could, similar to peripheral arterial occlusive disease, lead to a new possibility of non-invasive assessment of disease progression in the future.

NCT ID: NCT05925946 Not yet recruiting - Diabetes Mellitus Clinical Trials

Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM

CURE-DM
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. A low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the DiRECT study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.

NCT ID: NCT05924516 Not yet recruiting - Clinical trials for Diabetes Mellitus Type 2

Randomized Clinical Trial to Evaluate the Efficacy of a Digital Intervention for Patients With Type 2 Diabetes

DIAVERA
Start date: February 2024
Phase: N/A
Study type: Interventional

This study aims to perform a digital intervention in patients with type 2 diabetes to analyze the efficacy of the digital intervention Adhera® Fatigue Digital Program in order to improve diabetes self-management and improve clinical outcomes, including chronic condition-related fatigue. This will be done through a randomized clinical trial in 3 of the main health centers in the city of Xalapa, Veracruz, Mexico. The digital health intervention is designed to be used for approximately 3 months. The study will enroll 150 participants (75 in control group and 75 in experimental group) who are patients with type 2 diabetes. There will be educational contents and personalized motivational messages through the Adhera Health Recommender System.

NCT ID: NCT05912218 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

REducing Diabetic macrovascUlar Complications duE to Peripheral Arterial Disease- REDUCE-PAD

REDUCE-PAD
Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, multi-centre study conducted at 3 sites in Singapore (SGH and NUHS, KTPH). 70 patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) will be randomised in a ratio 1:1 to receive normal saline control or MEDI6570 400mg by monthly subcutaneous injection for 9 months.

NCT ID: NCT05910840 Not yet recruiting - Diabetes Mellitus Clinical Trials

Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care

Support-t
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The investigators will conduct a randomized controlled trial (RCT) to examine how an online training and peer support platform could help the preparation to transition to adult care. Among 14-16 year old youth with Type 1 Diabetes (T1D), the investigators aim to assess the effect of an online training and peer support platform (Support-t) integrated in usual care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures during the preparation for transition to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority RCT of adolescents with T1D (14-16 years of age) followed at one of 4 university teaching hospital-based pediatric diabetes clinics in the province of Quebec.

NCT ID: NCT05899023 Not yet recruiting - Diabetes Mellitus Clinical Trials

ED Diabetes Screening and Outpatient Care

Start date: November 30, 2025
Phase: N/A
Study type: Interventional

This goal of this NIH funded R01 study is to identify risk factors for not being able to follow-up for a new diagnosis of diabetes in the emergency department and improve linkage of these newly diagnosed patients to appropriate outpatient care. Its three aims will be accomplished through 1) a retrospective chart review of emergency department (ED) patients screened for diabetes, 2) a series of prospective qualitative interviews among ED patients with newly diagnosed diabetes who fail to follow-up for outpatient care, and 3) a simple randomized controlled trial to test the efficacy of telehealth bridge visits to connect ED patients with newly diagnosed diabetes to outpatient primary care.

NCT ID: NCT05870280 Not yet recruiting - Diabetes Mellitus Clinical Trials

Nurse Coaching the Effect of on Glycemic Control, Fear of Hypoglycemia and Risk Perception in Adults With Type 1 Diabetes.

Start date: August 30, 2023
Phase: N/A
Study type: Interventional

Because of the unforeseen rate of increase in case numbers, the high rates of mortality and morbidity, and the increased socio economic load it causes, diabetes has become the most discussed chronic and widespread metabolic disease in Turkey, and throughout the World, there are focused efforts to find a solution. It is very important for a person to self-assesss and evaluate to draw a roadmap for improved outcomes in a disease with a high financial and moral burden. A nurse is not only a caregiver to patients, but also a person who guides them to increased engagement and motivation in the care of their illness. Integrative Nurse Coaching is gaining notoriaty as an effective method to improve patient engagament and motivation in self-responsibility for health. The Integrative Nurse Coach Academy in the USA carries out studies and trainings to further this improvement. With cooperation between United States and Turkish nurse colleagues, it aims to bring Integrative Nurse Coach practice to Turkey. The Integrative Nurse Coach uses the nursing process as a framework to guide nurse coaching practice. This requires a shift in traditional nursing terminology and meaning to understand and incorporate the patient's subjective experience as follows: from assessment to stablishing a relationship, identifying readiness for change and the resources available to the patient for change; from nursing diagnosis to identifying opportunities and issues; from outcomes to having the patient set the agenda for achievement of the patient's goals; from 3 planning to creating the structure of the coaching interaction; from intervention to empowering the patient to reach goals; and from evaluating to assisting the patient to determine the extent to which goals were achieved. The Theory of Integrative Nurse Coaching (TINC) , developed by the Integrative Nurse Coach Association , sheds light on this point. The TINC encompasses many holistic nursing theories and contains three concepts and five components. The three concepts are healing, metaparadigm in nursing theory (nurse, person, health, environment), and patterns of knowing in nursing (personal, empirics, aesthetics, ethical, not knowing, sociopolitical. The TINC five components include Integrative Nurse Coach Self-Development (self-reflection, self-assessment, self-evaluation self-care), Integral Perspective and Change, Integrative Lifestyle Health and Well-Being, Awareness and Choice, and Listening With Heart The five components all have equal value and form the basis for the nurse coach professional practice model. There is a parallel process of self-development for both the nurse coach and the client. The SelfDevelopment component empowers individuals (including the nurse coach) to focus on their health and wellness from an integral perspective and to identify their individual knowledge, expertise, strengths, and resources, while recognizing the fluidity of the change. The TINC is designed to guide nurse coaching practice, education, research, and health care policy. The theory emphasizes, describes, and directs the practice of nurse coaching, a recognized holistic nursing modality. It has been seen that the TINC framework is very suitable for individuals with diabetes to provide their own management.

NCT ID: NCT05866900 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 1

The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System

CHOco-AID
Start date: May 15, 2023
Phase:
Study type: Observational

Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.