Type 1 DiabetesRTDNCT00441129
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
A study testing Minimed paradigm Real Time Sytem and Minimed Paradigm 512/712 Insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 8 sites in France.
Trial summary
In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII… Read more about this study
- Who is it for?
- Ages 2 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Minimed paradigm Real Time Sytem and Minimed Paradigm 512/712 Insulin pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 8 sitesFrance
- Study dates
- Jun 2006to May 2008
- 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 2 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient has signed informed consent form prior to study entry.
- Patients have been diagnosed with Type 1 DM at least 12 months prior to inclusion.
- Patients should have been received diabetes care from the investigator of each center at least 3 months prior to inclusion.
- Patients have been treated with multiple daily injections and use rapid Insulin Analog for their meal prior to study entry.
- Have an HbA1c value ≥ 8 %.
- Pediatric patients must be aged between 2 and 18 years old and adult patients be aged between 19 and 65 years old.
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- Patients must perform at least 3 self-monitoring blood glucose finger-sticks daily.
- Patients from PRT group must be willing to wear sensors and transmitter connected to the pump Paradigm® Real-Time for up to 24 weeks and to change sensors, insulin infusion sets and reservoirs every 3 days (~60 times during the study period ).
- Patients from CSII group must be willing to wear an insulin pump, change insulin infusion sets, and reservoirs every 3 days (~60 times during the study period ).
- Patient is required to use the Paradigm® Real-Time system at least 70% of the time during the study period.
- Patients in both groups are required to wear at the beginning and the end of the study a CGMS for 3 days. and to perform 6 self-monitoring blood glucose finger-sticks daily during the 3 days.
- Patients must be willing to undergo all study procedures, to receive a technical training to understand how to use the Paradigm® Real-Time System or the Insulin Pump depending of the randomization.
- Patients must agree to receive a training on how to adapt their insulin doses to their meals, how to calculate and apply corrective treatment.
Who cannot join
- Hearing or vision impairment so that alarms cannot be recognized.
- Alcohol or drug abuses other than nicotine.
- Allergy to sensor or components of the sensor.
- Allergy to insulin infusion set or components of the insulin infusion set.
- Patient is pregnant or of child-bearing potential during the study.
- Patient does not have a reliable support person or the patient is unwilling to comply with the provisions of the protocol.
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- Patients suffering from cancer, heart failure, kidney disease and other chronic debilitating conditions.
- Patients participating in other device or drug studies will be excluded.
- Patients may participate in this study only once.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Côte de Nacre
Caen, 14000
Hôpital Universitaire Debrousse
Lyon, 69322
Hôpital Sainte Marguerite
Marseille, 13009
CH La Peyronie
Montpellier, 34295
American Memorial Hospital
Reims, 51092
Hôpital Jeanne D'Arc
Saint-Mandé, 54202
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
CHU Rangueil
Toulouse, 31054
About this study
Official title: To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion
In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.
Read the detailed description
The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients
- Conditions
- Type 1 Diabetes
- Being tested
- Minimed paradigm Real Time Sytem, Minimed Paradigm 512/712 Insulin pump
- Keywords
- Improvement of the blood glucose control
- 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.
Minimed paradigm Real Time SytemDevice
Minimed paradigm Real Time Sytem
Minimed Paradigm 512/712 Insulin pumpDevice
Minimed Paradigm 512/712 Insulin pump
| Study group | Role | What they receive |
|---|---|---|
| Conventional insulin pump therapy | Active comparator | Conventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII) Receives: Device: Minimed Paradigm 512/712 Insulin pump |
| Minimed paradigm Real Time Sytem | Experimental | Minimed paradigm Real Time Sytem Receives: Device: Minimed paradigm Real Time Sytem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in HbA1C From Baseline and 6 Months
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Measured: Baseline and 6 months
Secondary outcomes (2)
Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline
Measured: Baseline and 6 months
Change From Baseline in Total Daily Dose (TDD)
Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- denis Raccah, professor, Principal investigator, DCCT Group, Effect of Intensive Treatment of diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. NJEM 1993; 329/977-986
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441129
- Sponsor's protocol ID
- 186
- Acronym
- RTD
- Status last verified
- Dec 2018
- First submitted
- 27 Feb 2007
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Raccah D, Sulmont V, Reznik Y, Guerci B, Renard E, Hanaire H, Jeandidier N, Nicolino M. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care. 2009 Dec;32(12):2245-50. doi: 10.2337/dc09-0750. Epub 2009 Sep 18.
PubMed 19767384
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion
- ClinicalTrials.gov ID
- NCT00441129
- Acronym / sponsor ID
- RTD / 186
- Conditions
- Type 1 Diabetes
- Keywords
- Improvement of the blood glucose control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006 (actual)
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 28 Feb 2007 (estimated)
- Results
- Posted 5 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.
Detailed description
The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional insulin pump therapy | Active comparator | Device: Minimed Paradigm 512/712 Insulin pumpConventional insulin pump therapy or continuous subcutaneous insulin infusion (CSII) |
| Minimed paradigm Real Time Sytem | Experimental | Device: Minimed paradigm Real Time SytemMinimed paradigm Real Time Sytem |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Patient has signed informed consent form prior to study entry.
- Patients have been diagnosed with Type 1 DM at least 12 months prior to inclusion.
- Patients should have been received diabetes care from the investigator of each center at least 3 months prior to inclusion.
- Patients have been treated with multiple daily injections and use rapid Insulin Analog for their meal prior to study entry.
- Have an HbA1c value ≥ 8 %.
Key exclusion criteria (9 listed)
- Hearing or vision impairment so that alarms cannot be recognized.
- Alcohol or drug abuses other than nicotine.
- Allergy to sensor or components of the sensor.
- Allergy to insulin infusion set or components of the insulin infusion set.
- Patient is pregnant or of child-bearing potential during the study.
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 |
|---|---|---|
| Minimed paradigm Real Time SytemMinimed paradigm Real Time Sytem | Device | Minimed paradigm Real Time Sytem |
| Minimed Paradigm 512/712 Insulin pumpMinimed Paradigm 512/712 Insulin pump | Device | Conventional insulin pump therapy |
Primary outcome
Difference in HbA1C From Baseline and 6 Months
Time frame: Baseline and 6 months
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
2 secondary outcomes
Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
Time frame: Baseline and 6 months
Change From Baseline in Total Daily Dose (TDD)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19767384Raccah D, Sulmont V, Reznik Y, Guerci B, Renard E, Hanaire H, Jeandidier N, Nicolino M. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care. 2009 Dec;32(12):2245-50. doi: 10.2337/dc09-0750. Epub 2009 Sep 18.
- Individual participant dataSharing planned: No
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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.
denis Raccah, professor principal investigator
DCCT Group, Effect of Intensive Treatment of diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. NJEM 1993; 329/977-986
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimed paradigm Real Time Sytem and Minimed Paradigm 512/712 Insulin pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 8 sites in France.
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 13 inclusion and 9 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 5 Dec 2018. 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. 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 5 Dec 2018). 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?
Difference in HbA1C From Baseline and 6 Months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00441129, which also lists 1 linked publication.
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 5 Dec 2018.