Type 1 DiabetesINDIGO 2NCT01429467
Glucose Variability in Type 1 Diabetes and Its Effect on Factors That Influence New Vessel Formation
A study testing Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®) in people with Type 1 Diabetes, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)
- Keywords
- Glucose Variability, Continuous Glucose Monitoring, Hypoxia-inducible Factor (HIF), Vascular Endothelial Growth Factor (VEGF), Erythropoietin, Cortisol
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)Device
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (5)
Change in Mean Area of Glucose Excursion (MAGE) following CGM
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.
Measured: 6 weeks
Change in levels of Hypoxia-inducible factor following CGM
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.
Measured: 6 weeks
Change in levels of Vascular Endothelial Growth Factor following CGM
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.
Measured: 6 weeks
Change in levels of erythropoietin following CGM
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.
Measured: 6 weeks
Change in levels of cortisol following CGM
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startAug 2012
- Primary completionFeb 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Tasker, University of Dundee
- Investigators
- Anthony PB Tasker, MBChB, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429467
- Sponsor's protocol ID
- AT/V01/010911
- Acronym
- INDIGO 2
- Status last verified
- May 2016
- First submitted
- 1 Sep 2011
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glucose Variability in Type 1 Diabetes and Its Effect on the Underlying Homeostatic Metabolic Pathways of Angiogenesis
- ClinicalTrials.gov ID
- NCT01429467
- Acronym / sponsor ID
- INDIGO 2 / AT/V01/010911
- Conditions
- Type 1 Diabetes
- Keywords
- Glucose Variability, Continuous Glucose Monitoring, Hypoxia-inducible Factor (HIF), Vascular Endothelial Growth Factor (VEGF), Erythropoietin, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring (CGM) | Other | Device: Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)Also: 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 | Device | Continuous Glucose Monitoring (CGM) |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Change in Mean Area of Glucose Excursion (MAGE) following CGM
Time frame: 6 weeks
Change in levels of Hypoxia-inducible factor following CGM
Time frame: 6 weeks
Change in levels of Vascular Endothelial Growth Factor following CGM
Time frame: 6 weeks
Change in levels of erythropoietin following CGM
Time frame: 6 weeks
Change in levels of cortisol following CGM
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony PB Tasker, MBChB principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®) in people with Type 1 Diabetes, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of HbA1c and level of Hypoxia-inducible Factor (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.