Glucose Variability in Type 1 Diabetes and Its Effect on Factors That Influence New Vessel Formation

University of Dundee35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)DEVICE

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: * 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

Locations (1)

University Of Dundee

Dundee, Angus, United Kingdom

Outcomes

Primary Outcomes

Correlation of HbA1c and level of Hypoxia-inducible Factor

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.

Time frame: Baseline

Correlation of HbA1c and level of Vascular Endothelial Growth Factor

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.

Time frame: Baseline

Correlation of HbA1c and level of Erythropoietin

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.

Time frame: Baseline

Correlation of HbA1c and level of cortisol

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.

Time frame: Baseline

Secondary Outcomes

Change in Mean Area of Glucose Excursion (MAGE) following CGM

The Mean Area of Glucose Excursion (MAGE) will be calculated for all phase 2 particpants from the CGM data in the first 3 days and last 3 days of the 6 week CGM period. These will then be compared to see if there is a statistical difference between MAGE after CGM intervention.

Time frame: 6 weeks

Change in levels of Hypoxia-inducible factor following CGM

Levels of Hypoxia-inducible factor will be measured in phase 2 participants post CGM and compared with baseline Hypoxia-inducible factor taken in phase 1 to see if there is a statistical difference.

Data from ClinicalTrials.gov

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