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

NCT ID: NCT01429467

Last Updated: 2016-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-12-31

Brief 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.

Conditions

Type 1 Diabetes

Keywords

Glucose Variability; Continuous Glucose Monitoring; Hypoxia-inducible Factor (HIF); Vascular Endothelial Growth Factor (VEGF); Erythropoietin; Cortisol

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: 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

Interventions

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

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

Intervention Type: DEVICE

Other Intervention Names

Enlite Guardian real-time system Medtronic®

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Anthony Tasker

SCREDS Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony PB Tasker, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

University Of Dundee

Dundee, Angus, United Kingdom

Countries

United Kingdom

Other Identifiers

AT/V01/010911

Identifier Type: -

Identifier Source: org_study_id