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

May 27, 2016 updated by: Anthony Tasker, University of Dundee

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • University of Dundee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anthony PB Tasker, MBChB, University of Dundee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

May 30, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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