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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT04354142 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Novel Carbohydrate Counting Smartphone App for Youth With Type 1 Diabetes

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

Type 1 Diabetes Mellitus (T1DM) is a common chronic disease of childhood. T1DM has substantial impact on quality of life (QOL), including burdensome dietary restrictions and the need to count carbohydrates in foods to safely dose insulin. Carbohydrate counting is challenging, inconvenient, and, if done wrong, can cause high or low blood glucose levels. To address these challenges, iSpy, a novel smartphone application, was created to identify foods and determine their carbohydrate content using pictures or speech. This pilot study is to evaluate if using iSpy improves carbohydrate counting accuracy and efficiency. Pilot participants will have carbohydrate counting (accuracy and efficiency) and their overall QoL (with respect to carbohydrate counting) assessed at baseline and after 3-months. The investigators hypothesize that using iSpy will make carbohydrate counting easier (by improving accuracy and efficiency) and enhance QoL for patients and/or their caregivers. If so, iSpy may help lessen the burden of living with T1DM.

NCT ID: NCT04354090 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

Start date: April 26, 2018
Phase: Phase 1
Study type: Interventional

JY09 is a glucagon-like peptide-1 (GLP-1) mimetic generated by genetic fusion of a Exendin-4 dimer to human immunoglobulin Fc. In this Double-blind, randomized, placebo-controlled trial, 41 healthy subjects received placebo or escalating doses of JY09 on day 1 in the first cohort, and on days 1 and 22 in the following sequential cohort 2-4, and on days 1, 15, and 30 in the cohort 5: cohort 1: 0.3 mg; cohort 2: 0.3 + 0.7 mg; cohort 3: 0.7+1.5 mg; cohort 4: 0.7+3.0 mg; and cohort 5: 0.7 + 1.5 + 6.0 mg. The primary endpoints were the incidence of adverse events and serious adverse events related to JY09. Secondary endpoints included pharmacodynamics and pharmacokinetics parameters, as well as anti-JY09 antibody incidence and titers.

NCT ID: NCT04351880 Completed - Cancer Clinical Trials

Meals MATTER: A Trial of Medically Tailored Meals 2 Weeks vs. 4 Weeks Post Hospital Discharge

Start date: April 16, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if medically tailored meals provided for either 2 weeks or 4 weeks (1 meal per day) to a Kaiser Permanente Colorado (KPCO) member after hospital discharge will improve their health. Medically tailored meals (MTM) are meals that are approved by a dietitian and shown to help people with certain health conditions.

NCT ID: NCT04350879 Completed - Diabetes Mellitus Clinical Trials

Diabetes Mellitus and Pregnancy : Knowledge Assessment

DMPKA
Start date: March 12, 2020
Phase:
Study type: Observational

Diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as preeclampsia, congenital malformations and macrosomia. Preconception care is all methods to assess the best prognostic for a diabetic pregnancy. Among these methods, contraception is very important to plan the pregnancy on a chosen moment. The content of the preconception care is well established. However, information of diabetic women concerning contraception and giabetic pregnancy has been little studied.

NCT ID: NCT04345497 Completed - Clinical trials for Diabetes Mellitus, Type 2

Diabetes-Specific Formula on Long Term Glycemic Control

Start date: August 26, 2020
Phase: N/A
Study type: Interventional

The study aims to investigate the effect of a diabetes-specific formula (DSF) used as a (partial) meal replacement on long-term glycemic control and short-term glycemic variability in individuals with type 2 diabetes.

NCT ID: NCT04344301 Completed - Hypertension Clinical Trials

The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults

Start date: August 31, 2020
Phase: N/A
Study type: Interventional

The investigators will conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with a 3-month follow up in older adults (≥65 years) with diabetes and hypertension. Participants will be randomized to receive AUDIO recordings of their clinic visits (AUDIO) in addition to After Visit Summary (AVS), or their AVS alone (Usual Care (UC). The investigators will recruit 90 adults (30 per site) over the targeted recruitment period of approximately 6 months. The primary outcome of interest is the feasibility of the trial and acceptability of the AUDIO intervention. The investigators will also explore the impact of AUDIO on patients' ability to self-manage care (as well as other exploratory health-related outcomes and healthcare utilization) at regular intervals from enrollment (T1 = 1 week, T2 = 3 months) compared to baseline (T0 = pre-visit) and usual care. The investigators will recruit patients from consented clinicians at three sites: Dartmouth-Hitchcock Primary Care (D-H; Manchester, NH), Vanderbilt University Medical Center (VUMC; Nashville, TN), and University of Texas Medical Branch, (UTMB; Galveston, TX).

NCT ID: NCT04344210 Completed - Clinical trials for Diabetes Mellitus, Type 2

Impact of Tele-interventions During the COVID-19 Pandemic in Patients With Diabetes Mellitus

Start date: April 17, 2020
Phase: N/A
Study type: Interventional

INTRODUCTION In critical situations, such as the current COVID 19 pandemic, themes of fear, uncertainty and stigmatization are common and constitute barriers to appropriate medical and mental health interventions. These challenges, when faced by those who live with a chronic disease, such as diabetes mellitus (DM), can negatively influence quality of life and adherence to treatment, compromising the control of the disease. OBJECTIVES The present study aims to investigate the effectiveness of a tele-intervention during the COVID-19 pandemic in improving glycemic control, lipid profile, blood pressure levels and parameters of medication adherence, mental well-being and sleep quality in patients with type 1 DM and type 2 DM. METHODS A randomized clinical trial will be carried out with patients with a previous diagnosis of type 1 DM and type 2 DM, who are registered at the Hospital de Clínicas de Porto Alegre (HCPA). Inclusion criteria will be age greater than or equal to 18 years, collection of HbA1c in the HCPA laboratory in January, February or March 2020 and availability to receive weekly phone calls. Patients will be randomized, stratified by type of diabetes, in two groups: G1: participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the social distancing period ; G2: participants will receive the usual care. The primary outcome assessed will be the variation in HbA1c levels comparatively between groups, with or without a tele-guided strategy, after four months of social distancing (or as long as the recommendation of social distancing measures remains). Secondary outcomes will include experiencing confirmation of COVID-19 infection, variation in lipid profile, blood pressure levels and variation in parameters of emotional distress related to diabetes, eating disorders, medication adherence, symptoms minor psychiatric disorders and altered sleep patterns, which will be evaluated with specific and validated scales. According to the sample calculation, 150 patients will be included in the study (92 with type 2 DM and 58 with type 1 DM). Analysis by intention to treat will be performed separately for patients with type 1 DM and with type 2 DM. SCHEDULE The proposed experiment will start immediately after approval of this project by the research ethics committee. The duration of the proposed intervention is 4 months (or as long as the recommendation of social distancing measures remains. This means that the study may be completed before or after that period, based on national recommendations for social distancing in Brazil), with a data analysis plan and publication of the results until September 2020.

NCT ID: NCT04343131 Completed - Clinical trials for Diabetes Mellitus, Type 1

Different Dietary Interventions and Glycemia in T1DM

Start date: November 2014
Phase: N/A
Study type: Interventional

The aim of the present study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).

NCT ID: NCT04342845 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effectiveness of Motivational Interviewing on Improving Care for Patients With Type 2 Diabetes in China

Start date: May 1, 2016
Phase: N/A
Study type: Interventional

n 2015, the International Diabetes Federation estimated that there were nearly 110 million diabetes mellitus (DM) patients in China, which was the highest number recorded in the world. China's DM-related costs, ranked second highest globally, were estimated to be US$51 billion. In response to the rising patient numbers and costs, the Chinese government has invested heavily in primary healthcare since 2009, with the goal of improving chronic disease management in the primary care settings. A key part of the primary care improvement program prioritizes health education as a route to lifestyle modification. Although the content and modes of delivery vary enormously, most of the programs focused on providing information rather than facilitating patient change. The impacts of traditional patient education on lifestyle modification and changes in psychological status have been reported to be suboptimal. These may be related to the poor understanding of the educational content or lack of means for making changes as a result of low socioeconomic status and poor educational level. It is therefore necessary to rethink and explore a more structured, patient-centered approach to health education at improving the outcomes of DM control. Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change. Counselors use empathy and other techniques to create an atmosphere to help patients to explore the discrepancies between the goals and their current behavior. The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Some studies show that MI can contribute to improve healthy eating, weight control and increases in physical activity, but most research focused on intermediate outcome measures and did not evaluate the readiness to change. MI can be utilized by a variety of healthcare providers, which makes it adaptable for different culture and clinical settings. However, the effectiveness of MI in Chinese diabetic patients remains uncertain. MI has been delivered using different methods. These methods have varied and included a single one-to-one session with a therapist, multiple group sessions, and the incorporation of MI into daily clinical practice. Furthermore, in yet another study, MI education program produced a significantly greater change in patients' perceived competence in dealing with diabetes than the control group. In this study, the investigators adopted the group MI approach and developed a patient empowerment program (PEP) utilizing the techniques and framework of MI. The investigators compared this to the most common form of DM education in China, i.e., when health professionals (nurses, doctors, dietitians or pharmacists) give a lecture on DM to patients and their carers in a hospital lecture theatre in a didactic manner.

NCT ID: NCT04340648 Completed - Diabetes Mellitus Clinical Trials

Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetectâ„¢ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2