Type 1 DiabetesPhase 2/3START-INNCT00949221
Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!)
A Phase 2/3 study testing monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing them to the risk of vascular complications in adulthood. One of the limiting factors is the daily number of self measurements of blood glucose required to optimize intensive insulin therapy. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Jul 2012
- Phase
- Phase 2/3
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 2 years and 17 years 11 months.
- Onset of type 1 diabetes ≥ 1 year.
- Centralized HPLC HbA1c ≥ 7.5% and < 11%.
- Intensive insulin therapy either by multiple daily injections ≥ 3 / day (rapid insulin analogue before 3 meal and 1 to 2 injections of basal insulin) or by continuous subcutaneous insulin infusion (pump).
- Followed in the centre for ≥ 3 months.
- Blood glucose self-monitoring ≥ 2/day.
Show all 9Show fewer
- No significant change of regimen insulin therapy for at least 3 months.
- Patient receiving medical health insurance.
- Patient who has given his consent
Who cannot join
- Non type 1 diabetes(type 2 diabetes or diabetes whose evolution suggest other origin).
- Association with another pathology which, in the discretion of the investigator, could affect the monitoring or be disturbed by the participation in the study.
- Association with chronic treatment (steroids, growth hormone…) or chronic disease, including hypothyroidism and celiac disease, non stabilized for 3 months.
- Association with severe skin disease.
- Deafness, hearing or visual defect.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Long-term Efficacy of 2 Strategies of Real Time Continuous Glucose Monitoring, Compared to Self BG-monitoring in Children and Adolescent With Type 1 Diabetes: a Randomized, Multicenter, Open Trial
Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing them to the risk of vascular complications in adulthood.
One of the limiting factors is the daily number of self measurements of blood glucose required to optimize intensive insulin therapy.
Read more
Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown its efficacy at short term (3 months). However, optimal clinical use of these devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability in medium and long term.
Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM (continuous or discontinuous) on glycemic control compared to conventional blood glucose self-monitoring (SMBG).
Population: Children and adolescents with type 1 diabetes with inadequate glycemic control despite intensive insulin therapy.
Read the detailed description
Despite the development of intensive insulin therapy, glycemic control defined by glycated haemoglobin (HbA1c) < 7,5% remains inadequate in pediatric patients with type 1 diabetes.
Improvement of the metabolic control is limited by the daily number of self measurements of blood glucose required to adjust closely insulin therapy
Improving glycemic control is particularly important in type 1 children and adolescent, whose risk of vascular complications in adulthood is high, due to the duration of the disease and whose adherence to current strategies of blood glucose self-monitoring is limited.
Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown improvement of HbA1c (≈ 1%) without increasing frequency of hypoglycaemia after continuous use for 3 months. Optimal clinical use of these new devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability at medium and long term.
Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM on glycemic control compared to conventional blood glucose self-monitoring.
Secondary objectives: overall comparison of 2 strategies of continuous use of RT CGM vs conventional SMBG on HbA1c ; to evaluate their effectiveness on others parameters of glycemic control (hypoglycaemias, ketoacidosis, glycemic variability); to evaluate impact on glycemic control of different factors including percentage of effective time of wearing the sensor; to evaluate : skin tolerance, acceptability of the device; quality of life and satisfaction to the use of the device; and medico-economic impact of the use of the device.
Population: Type 1 diabetes children and adolescent with inadequate metabolic control despite intensive insulin therapy, randomized in 3 groups. After a period of 3 months of continuous measurement for all of them, the two strategies will be an intensive glucose monitoring by continuous measurement for 9 months (a total of 12 months) and an intermediate consisting of discontinuous measurement (40% of the time for 9 months), compared to conventional blood glucose self-monitoring.
The reduction in HbA1c of at least 0,6% requires 50 patients per group, and a total of 150 children.
Primary endpoint: change in the rate of HbA1c.
Secondary endpoints: frequency of acute metabolic events, non-severe or symptomatic hypoglycaemia; measure of glycemic variability; skin tolerance; number of sensor used and percentage of effective time of use of the device; satisfaction of the patients; quality of life and diabetes-related quality of life; choice of the patient (continuing or not to use the device) at the end of the study; medico-economic evaluation.
Benefits expected with this clinical trial: improvement of glycemic control and quality of life in children and adolescents with type 1 diabetes. Furthermore, study results would permit to defined optimal strategy of using RT CGM in paediatric population.
- Conditions
- Type 1 Diabetes
- Being tested
- monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE
- Keywords
- Type 1 diabetes, Paediatric, Real Time Continuous Glucose Monitoring, Glycemic control, Therapeutic education
- 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.
monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CEDevice
- group 1: continuous glucose monitoring for 3 months, then conventional blood glucose self-monitoring for 9 months;
- group 2: intensive strategy using continuous glucose monitoring for 12 months;
- group 3: intermediate strategy using continuous glucose monitoring for 3 months, then discontinuous use of the device for 9 months (approximately 40% of the time, alternating with conventional blood glucose self-monitoring).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Continuous glucose monitoring for 3 months, then conventional blood glucose self-monitoring for 9 months Receives: Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE |
| Group 2 | Other | monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Intensive strategy using continuous glucose monitoring for 12 months Receives: Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE |
| Group 3 | Other | monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Intermediate strategy using continuous glucose monitoring for 3 months, then discontinuous use of the device for 9 months (approximately 40% of the time, alternating with conventional blood glucose self-monitoring). Receives: Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effect of 2 strategies of real time continuous glucose monitoring vs conventional SMBG on glycated haemoglobin = HbA1c measured at inclusion, 3, 6, 9, 12 months
Measured: 1 year
Secondary outcomes (9)
HbA1c and associated factors with HbA1c changes, others parameters of glycemic control, tolerance, acceptability, quality of life, satisfaction after use of real time continuous glucose monitoring in 150 pediatric patients
Measured: 3 months
Frequency of acute metabolic events (severe hypoglycaemia or ketoacidosis)
Measured: 1 year
Frequency of non-severe or symptomatic hypoglycaemia
Measured: 1 year
Average blood glucose and glycemic variability
Measured: 1 year
Tolerance of using the device of continuous glucose monitoring (skin tolerance)
Measured: 1 year
Acceptability of the device (percentage of time of use)
Measured: 1 year
General and diabetes-related Quality of life
Measured: 1 year
Satisfaction to use the device
Measured: 1 year
Medico-economic evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Tubiana, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949221
- Sponsor's protocol ID
- P070152
- Other IDs
- 2007-A01330-53
- Acronym
- START-IN
- Status last verified
- Jul 2012
- First submitted
- 29 Jul 2009
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Guilmin-Crepon S, Carel JC, Schroedt J, Scornet E, Alberti C, Tubiana-Rufi N. How Should We Assess Glycemic Variability in Type 1 Diabetes? Contribution of Principal Component Analysis for Interstitial Glucose Indices in 142 Children. Diabetes Technol Ther. 2018 Jun;20(6):440-447. doi: 10.1089/dia.2017.0404.
PubMed 29923773Guilmin-Crepon S, Carel JC, Schroedt J, Sulmont V, Salmon AS, Le Tallec C, Coutant R, Dalla-Vale F, Stuckens C, Bony-Trifunovic H, Crosnier H, Kurtz F, Kaguelidou F, Le Jeannic A, Durand-Zaleski I, Couque N, Alberti C, Tubiana-Rufi N. Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French multi-center, prospective, controlled randomized trial (Start-In!). Pediatr Diabetes. 2019 May;20(3):304-313. doi: 10.1111/pedi.12820. Epub 2019 Feb 6.
PubMed 30663187Le Jeannic A, Maoulida H, Guilmin-Crepon S, Alberti C, Tubiana-Rufi N, Durand-Zaleski I. How to collect non-medical data in a pediatric trial: diaries or interviews. Trials. 2020 Jan 7;21(1):36. doi: 10.1186/s13063-019-3997-9.
PubMed 31910885
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Efficacy of 2 Strategies of Real Time Continuous Glucose Monitoring, Compared to Self BG-monitoring in Children and Adolescent With Type 1 Diabetes: a Randomized, Multicenter, Open Trial
- ClinicalTrials.gov ID
- NCT00949221
- Acronym / sponsor ID
- START-IN / P070152
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Paediatric, Real Time Continuous Glucose Monitoring, Glycemic control, Therapeutic education
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Jul 2009 (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.
Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing them to the risk of vascular complications in adulthood.
One of the limiting factors is the daily number of self measurements of blood glucose required to optimize intensive insulin therapy.
Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown its efficacy at short term (3 months). However, optimal clinical use of these devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability in medium and long term.
Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM (continuous or discontinuous) on glycemic control compared to conventional blood glucose self-monitoring (SMBG).
Population: Children and adolescents with type 1 diabetes with inadequate glycemic control despite intensive insulin therapy.
Detailed description
Despite the development of intensive insulin therapy, glycemic control defined by glycated haemoglobin (HbA1c) < 7,5% remains inadequate in pediatric patients with type 1 diabetes.
Improvement of the metabolic control is limited by the daily number of self measurements of blood glucose required to adjust closely insulin therapy
Improving glycemic control is particularly important in type 1 children and adolescent, whose risk of vascular complications in adulthood is high, due to the duration of the disease and whose adherence to current strategies of blood glucose self-monitoring is limited.
Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown improvement of HbA1c (≈ 1%) without increasing frequency of hypoglycaemia after continuous use for 3 months. Optimal clinical use of these new devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability at medium and long term.
Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM on glycemic control compared to conventional blood glucose self-monitoring.
Secondary objectives: overall comparison of 2 strategies of continuous use of RT CGM vs conventional SMBG on HbA1c ; to evaluate their effectiveness on others parameters of glycemic control (hypoglycaemias, ketoacidosis, glycemic variability); to evaluate impact on glycemic control of different factors including percentage of effective time of wearing the sensor; to evaluate : skin tolerance, acceptability of the device; quality of life and satisfaction to the use of the device; and medico-economic impact of the use of the device.
Population: Type 1 diabetes children and adolescent with inadequate metabolic control despite intensive insulin therapy, randomized in 3 groups. After a period of 3 months of continuous measurement for all of them, the two strategies will be an intensive glucose monitoring by continuous measurement for 9 months (a total of 12 months) and an intermediate consisting of discontinuous measurement (40% of the time for 9 months), compared to conventional blood glucose self-monitoring.
The reduction in HbA1c of at least 0,6% requires 50 patients per group, and a total of 150 children.
Primary endpoint: change in the rate of HbA1c.
Secondary endpoints: frequency of acute metabolic events, non-severe or symptomatic hypoglycaemia; measure of glycemic variability; skin tolerance; number of sensor used and percentage of effective time of use of the device; satisfaction of the patients; quality of life and diabetes-related quality of life; choice of the patient (continuing or not to use the device) at the end of the study; medico-economic evaluation.
Benefits expected with this clinical trial: improvement of glycemic control and quality of life in children and adolescents with type 1 diabetes. Furthermore, study results would permit to defined optimal strategy of using RT CGM in paediatric population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CEmonitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Continuous glucose monitoring for 3 months, then conventional blood glucose self-monitoring for 9 months |
| Group 2 | Other | Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CEmonitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Intensive strategy using continuous glucose monitoring for 12 months |
| Group 3 | Other | Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CEmonitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Intermediate strategy using continuous glucose monitoring for 3 months, then discontinuous use of the device for 9 months (approximately 40% of the time, alternating with conventional blood glucose self-monitoring). |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age between 2 years and 17 years 11 months.
- Onset of type 1 diabetes ≥ 1 year.
- Centralized HPLC HbA1c ≥ 7.5% and < 11%.
- Intensive insulin therapy either by multiple daily injections ≥ 3 / day (rapid insulin analogue before 3 meal and 1 to 2 injections of basal insulin) or by continuous subcutaneous insulin infusion (pump).
- Followed in the centre for ≥ 3 months.
Key exclusion criteria (5 listed)
- Non type 1 diabetes(type 2 diabetes or diabetes whose evolution suggest other origin).
- Association with another pathology which, in the discretion of the investigator, could affect the monitoring or be disturbed by the participation in the study.
- Association with chronic treatment (steroids, growth hormone…) or chronic disease, including hypothyroidism and celiac disease, non stabilized for 3 months.
- Association with severe skin disease.
- Deafness, hearing or visual defect.
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 |
|---|---|---|
| monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE* group 1: continuous glucose monitoring for 3 months, then conventional blood glucose self-monitoring for 9 months; * group 2: intensive strategy using continuous glucose monitoring for 12 months; * group 3: intermediate strategy using continuous glucose monitoring for 3 months, then discontinuous use of the device for 9 months (approximately 40% of the time, alternating with conventional blood glucose self-monitoring). | Device | Group 1, Group 2, Group 3 |
Primary outcome
Comparison of the effect of 2 strategies of real time continuous glucose monitoring vs conventional SMBG on glycated haemoglobin = HbA1c measured at inclusion, 3, 6, 9, 12 months
Time frame: 1 year
9 secondary outcomes
HbA1c and associated factors with HbA1c changes, others parameters of glycemic control, tolerance, acceptability, quality of life, satisfaction after use of real time continuous glucose monitoring in 150 pediatric patients
Time frame: 3 months
Frequency of acute metabolic events (severe hypoglycaemia or ketoacidosis)
Time frame: 1 year
Frequency of non-severe or symptomatic hypoglycaemia
Time frame: 1 year
Average blood glucose and glycemic variability
Time frame: 1 year
Tolerance of using the device of continuous glucose monitoring (skin tolerance)
Time frame: 1 year
Acceptability of the device (percentage of time of use)
Time frame: 1 year
General and diabetes-related Quality of life
Time frame: 1 year
Satisfaction to use the device
Time frame: 1 year
Medico-economic evaluation
Time frame: 1 year
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 6 Feb 2023.
- Results publication: PubMed 29923773Guilmin-Crepon S, Carel JC, Schroedt J, Scornet E, Alberti C, Tubiana-Rufi N. How Should We Assess Glycemic Variability in Type 1 Diabetes? Contribution of Principal Component Analysis for Interstitial Glucose Indices in 142 Children. Diabetes Technol Ther. 2018 Jun;20(6):440-447. doi: 10.1089/dia.2017.0404.
- Results publication: PubMed 30663187Guilmin-Crepon S, Carel JC, Schroedt J, Sulmont V, Salmon AS, Le Tallec C, Coutant R, Dalla-Vale F, Stuckens C, Bony-Trifunovic H, Crosnier H, Kurtz F, Kaguelidou F, Le Jeannic A, Durand-Zaleski I, Couque N, Alberti C, Tubiana-Rufi N. Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French multi-center, prospective, controlled randomized trial (Start-In!). Pediatr Diabetes. 2019 May;20(3):304-313. doi: 10.1111/pedi.12820. Epub 2019 Feb 6.
- Results publication: PubMed 31910885Le Jeannic A, Maoulida H, Guilmin-Crepon S, Alberti C, Tubiana-Rufi N, Durand-Zaleski I. How to collect non-medical data in a pediatric trial: diaries or interviews. Trials. 2020 Jan 7;21(1):36. doi: 10.1186/s13063-019-3997-9.
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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.
Nadia Tubiana, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 9 inclusion and 5 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 6 Feb 2023. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparison of the effect of 2 strategies of real time continuous glucose monitoring vs conventional SMBG on glycated haemoglobin = HbA1c measured at inclusion, 3, 6, 9, 12 months (time frame: 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 NCT00949221, which also lists 3 linked publications.
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 6 Feb 2023.