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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT03138447 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group

DHIT
Start date: March 30, 2017
Phase: N/A
Study type: Interventional

The digital health tool is an application ("app") available on iOS and Android enabled mobile phones. Health Care Providers ("HCPs") configure algorithms which can be tailored to individual patient's needs and then prescribe the app to support optimal basal insulin titration and dosing. In this study, participants will be recruited from a medical practice in which an HCP has prescribed a once-daily basal insulin. Participants will be trained on the use of the app utilizing their own mobile phone. During training, a brief self-assessment survey will be administered. After 90 days of usage, a telephone survey will be conducted. The baseline A1C results and the end of study A1C results will be collected from the patients' routine clinical care records. Data from the retrospective control group will be collected from a chart review of the same practice.

NCT ID: NCT03138174 Completed - Diabetes Mellitus Clinical Trials

OneTouch Verio Flex System Accuracy Evaluation

OTVFSA
Start date: March 23, 2017
Phase: N/A
Study type: Observational

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197

NCT ID: NCT03136939 Completed - Diabetes Mellitus Clinical Trials

Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus

Start date: January 1, 2017
Phase: N/A
Study type: Observational

10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ)which secreted by IGRP-specific T cell. Results were compared between these groups.

NCT ID: NCT03136484 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

SUSTAIN 8
Start date: March 15, 2017
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin

NCT ID: NCT03136471 Completed - Clinical trials for Diabetes Mellitus, Type 2

Impact of CMS Reimbursement Policy Supporting Care Coordination in Louisiana

Start date: January 2017
Phase:
Study type: Observational

Investigators propose to use a natural experiment design to examine the impacts of the new CPT code (99490) for chronic care management on health outcomes. The Investigators will collaborate with partners in the Louisiana Clinical Data Research Network (LaCDRN) who serve more than 90,000 patients with type 2 diabetes mellitus in Louisiana to examine impacts of the CMS reimbursed care coordination. Now, LaCDRN is renamed as Research Action for Health Network (REACHnet). Patient and stakeholder engagement will be planned and implemented across all phases of this natural experiment. This project will examine outcome differences created by the policy change in a natural experiment framework. The analyses will utilize the RE-AIM framework to identify the critical elements of the programs that will enhance the reach, effectiveness, adoption, implementation, and maintenance of these strategies in the diverse LaCDRN diabetes populations. PCORI Proposal COVID-19- Related Enhancement for Existing Research: The proposed enhancement will contribute timely information to address two important implications of the coronavirus pandemic: 1. Disparities in continuity of care and 2. Health systems' responsiveness in terms of telehealth delivery for high risk populations. The enhancement builds upon our current project by further examining effects of CMS payment innovations to expand remotely delivered care. Our proposed study is a rapid assessment of telehealth services, using an existing "learning health system" infrastructure to provide timely, actionable evidence to inform telehealth service provision during the pandemic and recovery.

NCT ID: NCT03135535 Completed - Diabetes Clinical Trials

Micro-mobile Foot Compression and Diabetic Foot

Start date: May 2, 2017
Phase: Phase 2
Study type: Interventional

Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene. A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc). The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health.

NCT ID: NCT03132181 Completed - Clinical trials for Diabetes Mellitus Type 2 (T2DM)

Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes

EMPA
Start date: April 24, 2017
Phase: Phase 2
Study type: Interventional

SGLT2 inhibitors are a novel class of glucose lowering drugs that act in the kidney by inhibiting SGLT2-mediated glucose reabsorption in the proximal tubule. The resulting increase in urinary glucose excretion leads to a reduction in plasma glucose levels. This is accompanied by reduction of total body weight due to urinary energy loss. In addition, glucose dependent osmotic diuresis contributes to blood pressure lowering effects of SGLT2 inhibition. Aim of the trial is to assess hemodynamic changes by empagliflozin, identify new empagliflozin dependent metabolic regulators and evaluate empagliflozin dependent effects on cardiac function.

NCT ID: NCT03130699 Completed - Clinical trials for Diabetes Mellitus, Type 2

Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes

DD-Me
Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile health) intervention that is tailored to individuals' needs and behavioral progress, in improving diabetes clinical control, adherence, and patient-provider communication in Hispanics - an at-risk, understudied population that experiences disparities in diabetes prevalence and outcomes. These striking disparities in the growing and aging US Hispanic population have taxed the US healthcare system, while significantly reducing quantity and quality of life for millions of individuals. By offering an innovative, scalable, and sustainable approach that seamlessly integrates several mHealth technologies into existing primary care team processes to improve the health of Hispanics (and eventually, other at-risk, underserved groups), DD-Me has strong potential to significantly impact public health.

NCT ID: NCT03127852 Completed - Heart Failure Clinical Trials

Effects of Remote Patient Monitoring on Chronic Disease Management

Start date: August 23, 2016
Phase: N/A
Study type: Interventional

Remote patient monitoring is a potential component for the management of chronic conditions that may provide reliable and real-time physiological measurements for clinical decision support, alerting, and patient self-management. The purpose of this study is to evaluate an UHN-built remote monitoring system for patients with complex chronic conditions called Medly.

NCT ID: NCT03124134 Completed - Obesity Clinical Trials

Gelesis Glycemic Index Study

GLIDE
Start date: April 18, 2017
Phase: N/A
Study type: Interventional

A study to determine glucose and insulin responses to 50g and 100 g of carbohydrate with and without Gelesis200.