Type 1 DiabetesNCT00726440
Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients?
A study testing Navigator® in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 19 sites in 2 countries.
Trial summary
The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes… Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Navigator®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Feb 2008to Jun 2010
- 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 8 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 Diabetes for ≥ 12 months or more (including Cpeptide negative secondary diabetes)
- Children between 8 and 18 years old
- Adults between 18 and 60 years old
- Patients treated with basal-bolus insulin regimens, pump or multiple daily injection, only with analogs, for at least 6 months
- Performing at least 2 finger sticks glucose controls per day
- Able and motivated to use the device
- HbA1c ≥ 8% twice with HPLC method(DCA 2000 excluded)
- Written informed consent obtained prior to enrollment in the study
Who cannot join
- Blindness or impaired vision so the screen cannot be recognized
- Allergy to sensor
- Active proliferative retinopathy not stabilized by laser or vitrectomy occurence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during study
- Treatment with systemic corticosteroid or medication known to influence insulin sensitivity in the 3 months prioir to visit 1
- Pregnancy
- Manifest psychiatric disturbance
- Presence of any conditions (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actuel or anticipated that the investigators feels would compromise the patient safety or limit his/her successful participation in the study.
- Hemoglobinopathy that interfers with HbA1c measurement
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
France18 sites
CHU Jean Minjoz
Besançon, Besancon, 25030
CH SUD Francilien
Corbeil-Essonnes, Corbeil Essonnes, 91100
University Hospital Grenoble
Grenoble, Grenoble, 38043
Hopital Edouard Herriot
Lyon, Lyon, 69003
CHU Marseille Hôpitaux Sud
Marseille, Marseille, 13274
Chu Montpellier
Montpellier, Montpellier, 34295
CHU Hôpital Jeanne d'Arc
Nancy, Nancy, 54201
CHU Nantes
Nantes, Nantes, 44093
Hopital Hotel Dieu
Paris, Paris, 75004
CHU La Pitié Salpetrière
Paris, 75013
CHU Robert Debré
Paris, 75019
Hopital Haut Leveque
Pessac, Pessac, 33604
CHU de Reims-Hôpital Américain
Reims, 51100
CHU de Reims-Hôpital Robert debré
Reims, 51100
CHU Rennes
Rennes, Rennes, 35056
Hopital Bellevue
Saint-Etienne, Saint Etienne, 42055
CHU Strasbourg
Strasbourg, 67091
CHU Toulouse
Toulouse, Toulouse, 31403
About this study
Official title: Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?
The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.
Read the detailed description
The primary objective of the study is to determine whether patients with chronically poor glycaemic control as evidenced by HbA1c >= 8% twice can achieve improved metabolic control using during one year CGM together with educative program about insulin adaptation doses compared to conventional self monitoring finger sticks with educative program about insulin adaptation doses alone.
- Conditions
- Type 1 Diabetes
- Being tested
- Navigator®, Placebo
- Keywords
- Type 1 Diabetes, Real Time Continuous Glucose Monitoring System, HbA1c, Navigator®
- 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.
Navigator®Device
Patients will be encouraged to use the Navigator® all the time and to modify their treatment according to the device measurments. Patients will also follow and educational process in order to adapt insulin doses according to each sensor data
Navigator®Device
Patients will follow the same educational process as group1 concerning insulin doses adaptation.The duration of the use of the devicewill be determined at the consultation every each 3 months.
PlaceboDevice
Patients will have their usual follow up with self-monitoring blood glucose
| Study group | Role | What they receive |
|---|---|---|
| Group1-patient | Active comparator | The patient will be encouraged to use the Navigator® all the time and to modify his treatment according to the continous blood glucose measurements. The patients will follow an educational process in order to adapt insulin doses according to each sensor data. Receives: Device: Navigator® |
| Group2-diabetologist | Active comparator | The patient will follow the same educational process as group 1 concerning insulin dose adaptation. They will use the continous glucose monitoring device according to the diabetologist's prescription and they will receive precise instructions to make considering results. The duration of the use of the Navigator® will be increased if one of the following criteria is observed at the consultation each 3 months:
* HbA1c>=7.5%
* 1 severe hypoglycaemia or more
* More than 4 benign hypoglycaemia per week
According to these criteria, every 3 months, the duration of the use of the monitoring system will be increased as following:
* step 1: 3 sensors per month
* step 2: 4 sensors per month
* step 3: 5 sensors per month
* step 4: continuous use Receives: Device: Navigator® |
| Group3-Control | Placebo comparator | Usual follow up with self-monitoring blood glucose. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of HbA1c mean between the 3 groups
Measured: at 1 year
Secondary outcomes (7)
Comparison of glucose stability in the 3 groups
Measured: inclusion, M3, M6, M9, M12
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
Measured: study period
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12
Measured: prior to inclusion and prior to M3, M6, M9, M12
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection
Measured: inclusion, M3, M6, M9, M12
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups
Measured: inclusion and M12
Comparison of weight, insulin doses, in each group
Measured: study period
comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption
Measured: study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Riveline, MD, Study director, CH Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726440
- Sponsor's protocol ID
- 2007-A01022-51
- Status last verified
- Apr 2011
- First submitted
- 23 Jul 2008
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Riveline JP, Schaepelynck P, Chaillous L, Renard E, Sola-Gazagnes A, Penfornis A, Tubiana-Rufi N, Sulmont V, Catargi B, Lukas C, Radermecker RP, Thivolet C, Moreau F, Benhamou PY, Guerci B, Leguerrier AM, Millot L, Sachon C, Charpentier G, Hanaire H; EVADIAC Sensor Study Group. Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care. 2012 May;35(5):965-71. doi: 10.2337/dc11-2021. Epub 2012 Mar 28.
PubMed 22456864
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?
- ClinicalTrials.gov ID
- NCT00726440
- Acronym / sponsor ID
- 2007-A01022-51
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Real Time Continuous Glucose Monitoring System, HbA1c, Navigator®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Aug 2008 (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 "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.
Detailed description
The primary objective of the study is to determine whether patients with chronically poor glycaemic control as evidenced by HbA1c >= 8% twice can achieve improved metabolic control using during one year CGM together with educative program about insulin adaptation doses compared to conventional self monitoring finger sticks with educative program about insulin adaptation doses alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1-patient | Active comparator | Device: Navigator®The patient will be encouraged to use the Navigator® all the time and to modify his treatment according to the continous blood glucose measurements. The patients will follow an educational process in order to adapt insulin doses according to each sensor data. |
| Group2-diabetologist | Active comparator | Device: Navigator®The patient will follow the same educational process as group 1 concerning insulin dose adaptation. They will use the continous glucose monitoring device according to the diabetologist's prescription and they will receive precise instructions to make considering results. The duration of the use of the Navigator® will be increased if one of the following criteria is observed at the consultation each 3 months: * HbA1c>=7.5% * 1 severe hypoglycaemia or more * More than 4 benign hypoglycaemia per week According to these criteria, every 3 months, the duration of the use of the monitoring system will be increased as following: * step 1: 3 sensors per month * step 2: 4 sensors per month * step 3: 5 sensors per month * step 4: continuous use |
| Group3-Control | Placebo comparator | Device: PlaceboUsual follow up with self-monitoring blood glucose. |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Type 1 Diabetes for ≥ 12 months or more (including Cpeptide negative secondary diabetes)
- Children between 8 and 18 years old
- Adults between 18 and 60 years old
- Patients treated with basal-bolus insulin regimens, pump or multiple daily injection, only with analogs, for at least 6 months
- Performing at least 2 finger sticks glucose controls per day
Key exclusion criteria (8 listed)
- Blindness or impaired vision so the screen cannot be recognized
- Allergy to sensor
- Active proliferative retinopathy not stabilized by laser or vitrectomy occurence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during study
- Treatment with systemic corticosteroid or medication known to influence insulin sensitivity in the 3 months prioir to visit 1
- Pregnancy
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 |
|---|---|---|
| Navigator®Patients will be encouraged to use the Navigator® all the time and to modify their treatment according to the device measurments. Patients will also follow and educational process in order to adapt insulin doses according to each sensor data | Device | Group1-patient |
| Navigator®Patients will follow the same educational process as group1 concerning insulin doses adaptation.The duration of the use of the devicewill be determined at the consultation every each 3 months. | Device | Group2-diabetologist |
| PlaceboPatients will have their usual follow up with self-monitoring blood glucose | Device | Group3-Control |
Primary outcome
Comparison of HbA1c mean between the 3 groups
Time frame: at 1 year
7 secondary outcomes
Comparison of glucose stability in the 3 groups
Time frame: inclusion, M3, M6, M9, M12
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
Time frame: study period
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12
Time frame: prior to inclusion and prior to M3, M6, M9, M12
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection
Time frame: inclusion, M3, M6, M9, M12
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups
Time frame: inclusion and M12
Comparison of weight, insulin doses, in each group
Time frame: study period
comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption
Time frame: study period
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 9 Feb 2012.
- Derived from this study: PubMed 22456864Riveline JP, Schaepelynck P, Chaillous L, Renard E, Sola-Gazagnes A, Penfornis A, Tubiana-Rufi N, Sulmont V, Catargi B, Lukas C, Radermecker RP, Thivolet C, Moreau F, Benhamou PY, Guerci B, Leguerrier AM, Millot L, Sachon C, Charpentier G, Hanaire H; EVADIAC Sensor Study Group. Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care. 2012 May;35(5):965-71. doi: 10.2337/dc11-2021. Epub 2012 Mar 28.
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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.
Jean-Pierre Riveline, MD study director
CH Sud Francilien
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator® in people with Type 1 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 19 sites in 2 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 8 inclusion and 8 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 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Belgium. 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. Some participants in this study may receive a placebo. 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?
Comparison of HbA1c mean between the 3 groups (time frame: at 1 year). 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 NCT00726440, 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 9 Feb 2012.