Glucose Variability in Type 1 Diabetes and Its Effect on Factors That Influence New Vessel Formation (INDIGO 2)

University of Dundee

Status: Completed

Conditions: Type 1 Diabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01429467

AT/V01/010911

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Continuous Glucose Monitoring (CGM)

Other group

Description:

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.

Treatment:

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