Type 1 Diabetes Clinical Trial
— START-INOfficial 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
Verified date | July 2012 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Robert Debré | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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 The — View Citation
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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 1 year | ||
Secondary | 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 | 3 months | ||
Secondary | Frequency of acute metabolic events (severe hypoglycaemia or ketoacidosis) | 1 year | ||
Secondary | Frequency of non-severe or symptomatic hypoglycaemia | 1 year | ||
Secondary | Average blood glucose and glycemic variability | 1 year | ||
Secondary | Tolerance of using the device of continuous glucose monitoring (skin tolerance) | 1 year | ||
Secondary | Acceptability of the device (percentage of time of use) | 1 year | ||
Secondary | General and diabetes-related Quality of life | 1 year | ||
Secondary | Satisfaction to use the device | 1 year | ||
Secondary | Medico-economic evaluation | 1 year |
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