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Active clinical trials for "Diabetes Mellitus"

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Bridging the Gap to Adult Diabetes Care

Type1diabetes

Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. When transitioning from pediatric to adult care, over a third of youth have a care gap of >6 months. During this vulnerable period youth are at risk for acute life-threatening complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an increased risk of chronic diabetes complications. Gaps in care may be a result of deficiencies in transition processes causing some young people to be poorly prepared for adult care and dissatisfied with the transition process. Ineffective transition can lead to decreased frequency of diabetes visits and an increased risk of adverse events in young adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in adolescents with type 1 diabetes are associated with poor outcomes in early adulthood. Quality improvement initiatives can be designed to optimize care processes such as referral systems to adult diabetes providers. Our overall objective is to optimize care and outcomes for youth with diabetes as they transition to adult care. Specific Aim 1: To improve glycemic control in youth around the time of transition from pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a quality improvement intervention designed to improve transition care processes and to identify contextual factors associated with variation in outcomes.

Active7 enrollment criteria

Addressing Basic Needs to Improve Diabetes Outcomes in Medicaid Beneficiaries

Diabetes MellitusType 2

This pragmatic randomized trial will test the effectiveness of a basic needs navigation intervention compared to usual care among 500 adults (ages 18-75) with Medicaid, type 2 diabetes, and 1 or more unmet basic needs. Basic needs includes having such things as adequate food, housing, personal safety, and money for necessities. The primary study hypothesis is that participants who receive navigation to address unmet basic needs will have a greater reduction (M=0.5%) in HbA1c pre-post compared with participants receiving usual care. Consistent with the study's conceptual model, the effects of unmet basic needs on barriers to self-care (e.g., attention, stress, sleep), health behaviors (e.g., glucose monitoring, diet, clinical screenings) and health outcomes (e.g., emergency department utilization, hospitalization, quality of life) will be examined.

Active10 enrollment criteria

Stories for Change: Digital Storytelling for Diabetes Self-Management Among Somali Adults

Type2 Diabetes

Somali adults are more likely to have type 2 diabetes mellitus (T2D) and more likely to die from the disease than non-Somali whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Somali whites. Innovative approaches that arise from affected communities are needed to address these health disparities. Community-based participatory research (CBPR) has been successful in targeting health issues among Somali and immigrant populations; CBPR is an effective approach for addressing health behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership between immigrant communities and academic institutions called Rochester Healthy Community Partnership (RHCP) Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to promote behavior change among vulnerable populations. Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward engaging in health promoting behaviors to shape positive health behaviors of viewers through influences on attitudes and beliefs. RHCP partners from Somali communities identified T2D as a priority area for intervention, and have co-created each of the formative phases leading up to this proposal. Narrative theory and social cognitive theory formed the conceptual basis for intervention development. The study team conducted surveys and focus groups to derive the approach and personnel for building an authentic intervention that was created in a digital storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to derive the final intervention products in video format. The respective digital storytelling videos will be pilot tested with 80 patients in Rochester, MN. In a mirror project for Hispanic adults, the intervention was rated as highly acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change. The overall objective of this project is therefore to assess the efficacy of a digital storytelling intervention derived through a CBPR approach on self-management of T2D among Somali adults.

Active9 enrollment criteria

Study of the Pharmacologic Action of a GPR119 Agonist on Glucagon Counter-regulation During Insulin-induced...

Diabetes MellitusType 1

The purpose of this study is to test if a specific research medication could increase the response to low blood glucose in people with type 1 diabetes. The response of the body to low blood sugar will be measured in healthy people as a reference point.

Active46 enrollment criteria

Self-Management in Young Adults With Type 1 Diabetes

Type 1 Diabetes

Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C <7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. Modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with T1D. Therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population. The overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.

Active10 enrollment criteria

Probiotics in Newly Diagnosed T1D

Type 1 DiabetesType1diabetes1 more

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

Active11 enrollment criteria

Delivering Health: Addressing Diabetes and Food Insecurity

Food InsecurityDiabetes Mellitus1 more

Develop, implement, and evaluate the effectiveness of an intervention to use home-delivery of Type 2 diabetes (T2D)-appropriate food boxes with plain language adapted education materials to improve the nutritional health, physical activity, and health outcomes of low-income food insecure people with T2D in northwest Arkansas.

Active7 enrollment criteria

Cardiovascular Effects of Rapidly Declining Plasma Glucose in Patients With Type 1 Diabetes

Type 1 Diabetes

Type 1 diabetes (T1D) is an autoimmune metabolic disease characterised by impaired lack of endogenous insulin causing elevated plasma glucose levels and increased risk of microvascular and macrovascular complications. With respect to the cardiovascular system, patients with T1D have an up to 10-fold increased risk of sudden cardiac death compared to healthy individuals. Furthermore, diabetes constitutes a hypercoagulable state, which to some extent may explain why cardiovascular disease still is a major cause of mortality in patients with T1D. Due to treatment with exogenously delivered insulin, glycaemic variability with intra-day and inter-day plasma glucose concentrations fluctuating between high levels (peaks) and low levels (nadirs), are inevitable in patients with T1D. A potentially important factor in development of cardiovascular disease, associated with glycaemic variability, is the rate of increase and/or decline of plasma glucose. The aim of this study is to test the hypothesis that a rapid plasma glucose decline from a hyperglycaemic level to an euglycaemic level can induce changes in QT-interval and blood coagulation in a proarrhythmogenic and prothrombotic way. Twenty patients with T1D with a 1:1 distribution with chronic hyperglycaemia (HbA1C ≥63 mmol/mol) and with well-controlled diabetes (HbA1C ≤53 mmol/mol) will be recruited for a crossover study including two test days (protocols), P-rapid, a combined hyperglycaemic and euglycaemic clamp with rapidly declining plasma glucose and P-slow, a combined hyperglycaemic and euglycaemic clamp with slowly declining plasma glucose. Patients will be randomised 1:1 to start with P-rapid or P-slow. The cardiovascular effects will be investigated using Holter-ECG, Thrombelastography, Echocardiography and blood sampling. Given that cardiovascular disease is a major cause of death in patients with T1D and that patients with diabetes may be more susceptible for cardiac arrhythmias and thrombotic events compared to healthy individuals, it is important to identify cardiovascular risk factors related to acute changes in plasma glucose in order to improve prevention strategies and therapy.

Active23 enrollment criteria

A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory...

Type2 Diabetes

The purpose of this study is to determine which of Psyllium and Wheat Dextrin is more effective in lowering fasting blood sugar and hemoglobin A1c, and to evaluate the effects they have on laboratory values.

Active20 enrollment criteria

A Mobile Health-enabled Lifestyle Intervention Among Women With History of Gestational Diabetes(GDM)...

HealthyGestational Diabetes Mellitus in Pregnancy2 more

This study aims to explore: (1) the relationship between lifestyle factors (eating, movement behaviour, sleep and stress) and glycaemic profile, and (2) the feasibility of delivering lifestyle intervention through the proposed mHealth strategy.

Active19 enrollment criteria
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