- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949221
Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!) (START-IN)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Hopital Robert Debre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- No significant change of regimen insulin therapy for at least 3 months.
- Patient receiving medical health insurance.
- Patient who has given his consent
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Group 1
monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Continuous glucose monitoring for 3 months, then conventional blood glucose self-monitoring for 9 months
|
|
OTHER: Group 2
monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE: Intensive strategy using continuous glucose monitoring for 12 months
|
|
OTHER: Group 3
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).
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Frequency of acute metabolic events (severe hypoglycaemia or ketoacidosis)
Time Frame: 1 year
|
1 year
|
Frequency of non-severe or symptomatic hypoglycaemia
Time Frame: 1 year
|
1 year
|
Average blood glucose and glycemic variability
Time Frame: 1 year
|
1 year
|
Tolerance of using the device of continuous glucose monitoring (skin tolerance)
Time Frame: 1 year
|
1 year
|
Acceptability of the device (percentage of time of use)
Time Frame: 1 year
|
1 year
|
General and diabetes-related Quality of life
Time Frame: 1 year
|
1 year
|
Satisfaction to use the device
Time Frame: 1 year
|
1 year
|
Medico-economic evaluation
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nadia Tubiana, PH, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General 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.
- Guilmin-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.
- Le 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P070152
- 2007-A01330-53 (OTHER: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesTerminated
Clinical Trials on monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE
-
Medtronic DiabetesCompletedDiabetes Mellitus, Type 2United States, France, Germany, Austria, Canada, Hungary, Israel, Italy, Macedonia, The Former Yugoslav Republic of, Netherlands, Serbia, South Africa, Spain
-
Amsterdam UMC, location VUmcEli Lilly and CompanyCompletedType 1 Diabetes Mellitus | Hypoglycemia UnawarenessNetherlands
-
Jaeb Center for Health ResearchJDRF Artificial Pancreas ProjectCompletedType 1 DiabetesUnited States
-
Medtronic DiabetesCompletedType 1 DiabetesUnited States, Canada
-
University of MinnesotaMedtronic DiabetesCompletedDiabetes Mellitus | Chronic PancreatitisUnited States
-
Medtronic DiabetesCompletedType 1 DiabetesUnited States
-
Medtronic DiabetesCompletedDiabetes Mellitus, Type 1Netherlands, Slovenia, Denmark, Austria, Italy, Luxembourg, Spain
-
Steen AndersenMedtronicCompletedType 1 Diabetes MellitusDenmark
-
University of DundeeCompletedType 1 DiabetesUnited Kingdom
-
Medtronic DiabetesCompletedType 1 DiabetesUnited States