The Influence of Personality Characteristics and Emotions on Blood Glucose Levels Among Type 1 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- correlation between baseline personality characteristics, changing emotions throughout the day, and glycemic levels in patients with T1DM
研究概览
简要总结
The research goal is to find a correlation between patient personality characteristics, patients' mood and glycemic control. Eventually, using this information may allow treating physicians the ability to better balance glucose blood levels in patients with T1DM, by recognizing influencing psychological parameters. The conclusion from this research will add to other physiological parameters that are being studied today, and in the future will be integrated into an artificial pancreas.
The investigators believe that there is a correlation that hasn't been studied in the past between personality characteristics, daily emotions and the ability to balance glucose blood levels in patients with T1DM.
详细描述
Background:
Type 1 diabetes mellitus (T1DM), is an autoimmune disease in which cells from the immune system attack the beta cells, that produce insulin, in the pancreas. As a result of the subsequent complete insulinopenia, glycemic levels rise, and the patient completely relies on exogenous administration of sub-cutaneous insulin injections. The patients must adjust the amount of insulin along the day in accordance with measured glucose blood levels and their activities (eating, physical activity, etc.) Recently patients diagnosed with T1DM, are eligible for a continuous glucose monitor with FLASH technology (Freestyle Libre glucose monitor), within the Israeli health medical basket services. As a result, nowadays treating physicians can better monitor glucose blood levels during the day. The Freestyle Libre constantly measures subcutaneous glucose levels, translating them using a specifically designed algorithm to projected blood glucose levels. This allows for improved glycemic control and more accurate insulin dosing decisions for the patient with a tool to assess disease severity and control for the treating physician.
Using advanced algorithms, there is an enormous research effort in order to create an artificial pancreas- a glucose blood level monitor that informs an insulin pump regarding the amount of insulin that should be injected throughout the day. This will replace the patients ongoing burden of managing their glycemic levels and reduce patient dosing errors. In order to improve the already existing algorithms, inserting additional parameters into the equation may improve the predictive value of the algorithms, and thus improve the ability to balance glycemic levels in different situations. So far, most of the research in this area was performed using physiological parameters (heart rate, physical activity, nutrition, etc.).
In the suggested study the researchers wish to examine the influence of character and emotions on glycemic levels during the day. Finding a correlation between the mental and mood status and glycemia may allow for the creation of a more accurate algorithm, to better predict and balance glycemic levels in patients with T1DM.
Research hypothesis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females above 18 years old
- •Patients with a prior medical history diagnosis of T1DM
- •Patients who are using a continuous glucose monitor (CGM or FGM)
排除标准
- •Patients without a diagnosis of type 1 DM
- •patients who are not using a continuous glucose monitor (CGM or FGM)
- •patients who did not sign an informed consent
- •lack of judgment and underage populations
- •Patients without a mobile smart device (smart phone)
结局指标
主要结局
correlation between baseline personality characteristics, changing emotions throughout the day, and glycemic levels in patients with T1DM
时间窗: through study completion, an average of 1 year
correlation between patient personality characteristics, patients' mood and glycemic control. Eventually, using this information may allow us the ability to better balance glucose blood levels in patients with T1DM, by recognizing influencing psychological parameters
次要结局
未报告次要终点