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

NCT01429467 | Completed DMC

• 1 other identifier: AT/V01/010911
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Correlation of HbA1c and level of Hypoxia-inducible Factor

  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

  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

  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

  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 Outcomes (5)

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

  6 weeks

• Change in levels of Hypoxia-inducible factor following CGM

  6 weeks

• Change in levels of Vascular Endothelial Growth Factor following CGM

  6 weeks

• Change in levels of erythropoietin following CGM

  6 weeks

• Change in levels of cortisol following CGM

  6 weeks

Study Arms (1)

Continuous Glucose Monitoring (CGM)

OTHER

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®)

Interventions

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

Also known as: Enlite Guardian real-time system Medtronic®

Continuous Glucose Monitoring (CGM)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with Type 1 Diabetes
• On insulin pump therapy.
• Aged 5 years to 18 years.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

University Of Dundee

Dundee, Angus, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Anthony PB Tasker, MBChB

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SCREDS Lecturer

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 7, 2011
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

GB (1)