Improving Glucose Variability in Type 1 Diabetes and Its Effect on the Underlying Homeostatic Metabolic Pathways of Angiogenesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Correlation of HbA1c and level of cortisol
研究概览
简要总结
The aim of the study is to see how glycaemic control and glycaemic variability affect levels of HIF, VEGF, erythropoietin and cortisol in Paediatric Type 1 diabetics on insulin pump therapy.
详细描述
The study will have two parts. The first phase will look at all current paediatric type 1 diabetics in Tayside on continuous subcutaneous insulin pump therapy and measure their levels of Hypoxia-Inducible Factor (HIF), Vascular Endothelial Growth Factor (VEGF), erythropoietin and cortisol. This will help answer the question; Does glucose control (as expressed by HbA1c ) effect levels of HIF, VEGF, erythropoietin and cortisol? To our knowledge this will be the first human study comparing how HIF, VEGF, erythropoietin and cortisol are affected by glucose control
The second phase of the trial will chose 10 patients on insulin pump therapy and using a continuous glucose monitor (CGM), monitor their glucose variability over a period of 6 weeks. After this period their levels of HIF, VEGF, erythropoietin and cortisol will again be measured. This will help answer the question of whether there is a relationship between glucose variability and levels of HIF, VEGF, erythropoietin and cortisol. As we know that these factors are stimulated by episodes of hypo and hyperglycaemia, it is hypothesised that these factors will be lower in participants that demonstrate reduced glucose variability. It will be the first study to give detailed information on the relationship between HIF, VEGF, erythropoietin and cortisol and glucose variability.
By using telemedicine sessions during weeks 1, 3 and 5 of the participants wearing CGM we will aim to improve the participant's glucose variability. This will help give further information about glucose variability and the above factors as well as giving further evidence for the use of telemedicine and CGM to improve glycaemic control in adolescent diabetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase 1 inclusion:
- •Patients with Type 1 Diabetes
- •On insulin pump therapy.
- •Aged 5 years to 18 years.
- •Phase 2 inclusion:
- •Patents with Type 1 Diabetes
- •Diabetes diagnosis for 1 year
- •On insulin pump therapy for minimum of six months
- •Access to a computer with internet access and telephone
- •Agree to wear CGM for 6 weeks
- •Aged 12 years to 18 years
排除标准
- •Patients not on pump therapy
- •Patient less than 5 years and greater than 18 years
- •Phase 2 patients been on pump therapy for less than 6 months
- •Phase 2 patients without access to internet and telephone.
- •Phase 2 patients less than 12 years and greater than 18 years
- •Patients who do not have a good understanding of English
研究组 & 干预措施
Continuous Glucose Monitoring (CGM)
10 participants from phase 1 will undergo 6 weeks of CGM with telemedicine support at weeks 1,3 + 5. After this period HIF, Erythropoietin, VEGf and cortisol will again be measured and compared with the subjects glucose variability.
干预措施: Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®) (Device)
结局指标
主要结局
Correlation of HbA1c and level of cortisol
时间窗: Baseline
This will look at all the results from Phase 1 participants and see if their is a correlation between participants HbA1c and their level of Cortisol.
Correlation of HbA1c and level of Hypoxia-inducible Factor
时间窗: Baseline
This will look at all the results from Phase 1 participants and see if their is a correlation between participants HbA1c and their level of Hypoxia-inducible factor.
Correlation of HbA1c and level of Vascular Endothelial Growth Factor
时间窗: Baseline
This will look at all the results from Phase 1 participants and see if their is a correlation between participants HbA1c and their level of Vascular Endothelial Growth Factor.
Correlation of HbA1c and level of Erythropoietin
时间窗: Baseline
This will look at all the results from Phase 1 participants and see if their is a correlation between participants HbA1c and their level of Erythropoietin.
次要结局
- Change in Mean Area of Glucose Excursion (MAGE) following CGM(6 weeks)
- Change in levels of Hypoxia-inducible factor following CGM(6 weeks)
- Change in levels of Vascular Endothelial Growth Factor following CGM(6 weeks)
- Change in levels of erythropoietin following CGM(6 weeks)
- Change in levels of cortisol following CGM(6 weeks)
研究者
Anthony Tasker
SCREDS Lecturer
University of Dundee
