Diabetes MellitusNCT00111228
The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT
A study testing Guardian RT and SMBG only in people with Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 8 sites in 7 countries.
Trial summary
The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks. Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Guardian RT and SMBG only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Oct 2004to May 2005
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient has signed Informed consent form prior to Study Entry.
- Patients have been diagnosed with type 1 diabetes mellitus (DM) at least 12 months prior to Study Entry.
- HbA1c must be 8.1% or above at study entry day (central lab value).
- Patients must perform at least two self-monitoring blood glucose finger-sticks daily.
- Patients are on intensive insulin therapy; for multiple daily injections (MDI) patients specifically, be on a schedule of a minimum of 3 injections daily.
- Patients on intensive insulin therapy must be on continuous subcutaneous insulin infusion (CSII) or MDI at least 3 months prior to inclusion and should have been receiving diabetes care from the investigator of each centre for the 6 months prior to inclusion.
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- Patients must be using only insulin analogues or rapid-acting human insulin for their meal boluses.
- Patients are willing to undergo all study procedures.
- Patients are trained on how to adapt their insulin dose to their meals and are knowledgeable concerning how to calculate and apply corrective insulin boluses post-prandially, as well as on the influence of physical activity and other life style factors on their glycemia.
- Patients are willing to participate in a Guardian® RT product training course
- Patients understand how to adjust and administer corrective treatment.
Who cannot join
- Patient has hearing problems/is deaf.
- Patient has impaired vision/blindness so screen alarms cannot be recognized.
- Alcohol or drug abuse other than nicotine.
- Allergy to sensor or components of the sensor.
- Manifest psychiatric disturbances.
- Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
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- Patient does not have a reliable support person.
- Patient is unwilling or unable to comply with the provisions of the protocol.
- Patient has scheduled travel on a plane in the next 3 months.
- Patient has scheduled a vacation which will occur between Visit 1 and Visit 2.
- Patient is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this trial. The subject may only be enrolled in this study once. Patient has already participated in the Centre Qualification Phase.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
France2 sites
Hôpital Sud Francilien
Corbeil Esssonnes, 91106
CH Robert Debre
Paris, 75019
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset BH7 7DW
About this study
Official title: Randomised, Controlled, Multi-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of Guardian T Versus Conventional Self-Monitoring Blood Glucose
The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks.
Read the detailed description
Finger-stick based self-testing (SBGM), as well as diagnostic continuous glucose monitoring (CGMS®) allow diabetic patients to find a balance between the two hyper- and hypoglycemic extremes. Nevertheless, there are still patients who fail to achieve good control due to fear of hypoglycemia, or who underestimate post-prandial hyperglycemias.
The Guardian® RT Telemetered Glucose Monitoring System is indicated for continuous or periodic monitoring of real-time interstitial blood glucose values and low/high blood glucose alarms (when pre-set levels are reached) in persons with diabetes mellitus. The glucose values calculated by the device will be used to trigger hypo- and hyperglycemia alerts and will be displayed every 5 minutes. The Guardian® RT stores up to 21 days of data.
The overall primary objective of the study is to determine whether patients with poor glycemic control as evidenced by HbA1c > 8.1% can achieve improved metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks (control group) after 12 weeks of continuous use.
- Conditions
- Diabetes Mellitus
- Being tested
- Guardian RT, SMBG only
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian RTDevice
SMBG onlyDevice
SMBG only
| Study group | Role | What they receive |
|---|---|---|
| Continuous use of the Guardian RT | Experimental | Continuous use of the Guardian RT group Receives: Device: Guardian RT |
| Bi-weekly use of the Guardian RT (once every 2 weeks) | Experimental | Bi-weekly use of the Guardian RT (once every 2 weeks) group Receives: Device: Guardian RT |
| Control group. SMBG monitoring | Active comparator | Control group. SMBG monitoring group Receives: Device: SMBG only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period
Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline
Measured: baseline and 3 month after study
Secondary outcomes (1)
Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline
Average blood glucose - change from baseline to end of 3 month study period, calculated as average blood glucose at 3 month - average blood glucose at baseline
Measured: baseline and 3 month after study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dorothee Deiss, MD, Principal investigator, Klinik für Allgemeine Charité, CVK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111228
- Sponsor's protocol ID
- EU 007_022004
- Status last verified
- Jan 2019
- First submitted
- 18 May 2005
- Last updated
- 1 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled, Multi-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of Guardian T Versus Conventional Self-Monitoring Blood Glucose
- ClinicalTrials.gov ID
- NCT00111228
- Acronym / sponsor ID
- EU 007_022004
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 19 May 2005 (estimated)
- Results
- Posted 1 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to determine whether patients with poor glycemic control can improve metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks.
Detailed description
Finger-stick based self-testing (SBGM), as well as diagnostic continuous glucose monitoring (CGMS®) allow diabetic patients to find a balance between the two hyper- and hypoglycemic extremes. Nevertheless, there are still patients who fail to achieve good control due to fear of hypoglycemia, or who underestimate post-prandial hyperglycemias.
The Guardian® RT Telemetered Glucose Monitoring System is indicated for continuous or periodic monitoring of real-time interstitial blood glucose values and low/high blood glucose alarms (when pre-set levels are reached) in persons with diabetes mellitus. The glucose values calculated by the device will be used to trigger hypo- and hyperglycemia alerts and will be displayed every 5 minutes. The Guardian® RT stores up to 21 days of data.
The overall primary objective of the study is to determine whether patients with poor glycemic control as evidenced by HbA1c > 8.1% can achieve improved metabolic control using the real-time values of the Guardian® RT compared to conventional self-monitoring blood glucose finger-sticks (control group) after 12 weeks of continuous use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous use of the Guardian RT | Experimental | Device: Guardian RTContinuous use of the Guardian RT group |
| Bi-weekly use of the Guardian RT (once every 2 weeks) | Experimental | Device: Guardian RTBi-weekly use of the Guardian RT (once every 2 weeks) group |
| Control group. SMBG monitoring | Active comparator | Device: SMBG onlyControl group. SMBG monitoring group |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Patient has signed Informed consent form prior to Study Entry.
- Patients have been diagnosed with type 1 diabetes mellitus (DM) at least 12 months prior to Study Entry.
- HbA1c must be 8.1% or above at study entry day (central lab value).
- Patients must perform at least two self-monitoring blood glucose finger-sticks daily.
- Patients are on intensive insulin therapy; for multiple daily injections (MDI) patients specifically, be on a schedule of a minimum of 3 injections daily.
Key exclusion criteria (11 listed)
- Patient has hearing problems/is deaf.
- Patient has impaired vision/blindness so screen alarms cannot be recognized.
- Alcohol or drug abuse other than nicotine.
- Allergy to sensor or components of the sensor.
- Manifest 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 | Device | Bi-weekly use of the Guardian RT (once every 2 weeks), Continuous use of the Guardian RT |
| SMBG onlySMBG only | Device | Control group. SMBG monitoring |
Primary outcome
Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period
Time frame: baseline and 3 month after study
Hemoglobin A1c (HbA1c) - change from baseline to end of 3 month study period, calculated as A1c at 3 month - A1c at baseline
1 secondary outcome
Average Blood Glucose - Change From Baseline to End of 3 Month Study Period, Calculated as Average Blood Glucose at 3 Month - Average Blood Glucose at Baseline
Time frame: baseline and 3 month after study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dorothee Deiss, MD principal investigator
Klinik für Allgemeine Charité, CVK
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian RT and SMBG only in people with 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 11 inclusion and 11 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 1 Apr 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1c (HbA1c) - Change From Baseline to End of 3 Month Study Period (time frame: baseline and 3 month after study). 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 1 Apr 2019.