Type 1 Diabetes MellitusPhase 4NCT01331343
Effectiveness Study of the Guardian RT in Type 1 Diabetics
A Phase 4 study testing Guardian RT Telemetered Glucose Monitoring System in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 8 sites in 7 countries.
Trial summary
The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone. Read more about this study
- Who is it for?
- Ages 8 to 59 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Guardian RT Telemetered Glucose Monitoring System
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Jun 2004to Jun 2005
- Phase
- Phase 4
- 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 8 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 Diabetes for at least 12 months
- HbA1c must be 8.1% or above at study entry
- Intensive Insulin Therapy 3 months prior to study entry
Who cannot join
- Impaired hearing or vision (must see screens and hear alarms)
- Unable to comply with protocol
- Chronic debilitating or psychiatric disturbances
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
About this study
Official title: The Guard Control Trial - Randomized, Controlled, Muti-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of the Guardian RT Versus Conventional Self-Monitoring Blood Glucose
The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.
Read the detailed description
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Guardian RT Telemetered Glucose Monitoring System
- Keywords
- Diabetes, Glycemic Control, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian RT Telemetered Glucose Monitoring SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in A1c (%) between continuous use of CGM and control
Measured: 12 weeks
Secondary outcomes (2)
Difference in change in A1c (%) between biweekly use of CGM and control
Measured: 12 weeks
Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJun 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331343
- Sponsor's protocol ID
- EU007_022004
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Guard Control Trial - Randomized, Controlled, Muti-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of the Guardian RT Versus Conventional Self-Monitoring Blood Glucose
- ClinicalTrials.gov ID
- NCT01331343
- Acronym / sponsor ID
- EU007_022004
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes, Glycemic Control, Continuous Glucose Monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 8 Apr 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 purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.
Detailed description
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Type 1 Diabetes for at least 12 months
- HbA1c must be 8.1% or above at study entry
- Intensive Insulin Therapy 3 months prior to study entry
Key exclusion criteria (3 listed)
- Impaired hearing or vision (must see screens and hear alarms)
- Unable to comply with protocol
- Chronic debilitating or psychiatric disturbances
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 |
|---|---|---|
| Guardian RT Telemetered Glucose Monitoring System | Device | – |
Primary outcome
Difference in Change in A1c (%) between continuous use of CGM and control
Time frame: 12 weeks
2 secondary outcomes
Difference in change in A1c (%) between biweekly use of CGM and control
Time frame: 12 weeks
Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM
Time frame: 12 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 18 Apr 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guardian RT Telemetered Glucose Monitoring System in people with Type 1 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 8 sites in 7 countries.
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 3 inclusion and 3 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 18 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany, Israel, Italy, Slovenia and 2 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference in Change in A1c (%) between continuous use of CGM and control (time frame: 12 weeks). 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 18 Apr 2011.