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Completed

NCT Number: NCT01429467

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Dundee

Dundee, Angus, DD1 9SY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Enlite Guardian real-time system Medtronic®

Primary outcomes

  1. Correlation of HbA1c and level of Hypoxia-inducible Factor

    Time frame: 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.

  2. Correlation of HbA1c and level of Vascular Endothelial Growth Factor

    Time frame: 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.

  3. Correlation of HbA1c and level of Erythropoietin

    Time frame: 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.

  4. Correlation of HbA1c and level of cortisol

    Time frame: 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.

Secondary outcomes

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

    Time frame: 6 weeks

    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.

  2. Change in levels of Hypoxia-inducible factor following CGM

    Time frame: 6 weeks

    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.

  3. Change in levels of Vascular Endothelial Growth Factor following CGM

    Time frame: 6 weeks

    Levels of Vascular Endothelial Growth Factor will be measured in phase 2 participants post CGM and compared with baseline Vascular Endothelial Growth Factor taken in phase 1 to see if there is a statistical difference.

  4. Change in levels of erythropoietin following CGM

    Time frame: 6 weeks

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

  5. Change in levels of cortisol following CGM

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

Improving Glucose Variability in Type 1 Diabetes and Its Effect on the Underlying Homeostatic Metabolic Pathways of Angiogenesis

Acronym: INDIGO 2

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 7, 2011
Registry last updated
May 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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