Glucose Variability in Type 1 Diabetes and Its Effect on Factors That Influence New Vessel Formation
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)
Intervention type(s): Device
Intervention description(s): Phase 2 patients will receive 6 weeks of CGM (Enlite Guardian real-time system- Medtronic®). Optimisation of glycaemic control will be through a telemedicine system to deliver a standardised protocol to instruct changes in pump settings and insulin delivery rate. This has been devised in our department and used successfully in a clinical trial comparing MDI v. CSII in young people, sponsored by Diabetes UK. 2008-2010). Subjects will be contacted at 1, 3 and 5 weeks after starting the CGM
Other intervention name(s): Enlite Guardian real-time system Medtronic®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Glucose Variability; Continuous Glucose Monitoring; Hypoxia-inducible Factor (HIF); Vascular Endothelial Growth Factor (VEGF); Erythropoietin; Cortisol