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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Dundee.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Anthony Tasker, University of Dundee
ClinicalTrials.gov Identifier:
NCT01429467
First received: September 1, 2011
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Glucose Variability in Type 1 Diabetes and Its Effect on the Underlying Homeostatic Metabolic Pathways of Angiogenesis

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Correlation of HbA1c and level of Hypoxia-inducible Factor [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Correlation of HbA1c and level of Vascular Endothelial Growth Factor [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Correlation of HbA1c and level of Erythropoietin [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Correlation of HbA1c and level of cortisol [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Mean Area of Glucose Excursion (MAGE) following CGM [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in levels of Hypoxia-inducible factor following CGM [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in levels of Vascular Endothelial Growth Factor following CGM [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in levels of erythropoietin following CGM [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in levels of cortisol following CGM [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: 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
Other Name: Enlite Guardian real-time system Medtronic®

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429467

Contacts
Contact: Anthony PB Tasker, MBChB 441382740367 anthonytasker@nhs.net

Locations
United Kingdom
University Of Dundee Recruiting
Dundee, Angus, United Kingdom, DD1 9SY
Contact: Anthony P B Tasker, MBChB    44 1382 383558    a.p.b.tasker@dundee.ac.uk   
Principal Investigator: Anthony PB Tasker, MBChB         
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Anthony PB Tasker, MBChB University of Dundee
  More Information

No publications provided

Responsible Party: Anthony Tasker, SCREDS Lecturer, University of Dundee
ClinicalTrials.gov Identifier: NCT01429467     History of Changes
Other Study ID Numbers: AT/V01/010911
Study First Received: September 1, 2011
Last Updated: August 20, 2012
Health Authority: Scotland: Scottish Executive Health Department

Keywords provided by University of Dundee:
Glucose Variability
Continuous Glucose Monitoring
Hypoxia-inducible Factor (HIF)
Vascular Endothelial Growth Factor (VEGF)
Erythropoietin
Cortisol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014