NCT00949221

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 6, 2023

Status Verified

July 1, 2012

Enrollment Period

2.8 years

First QC Date

July 29, 2009

Last Update Submit

February 3, 2023

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesPaediatricReal Time Continuous Glucose MonitoringGlycemic controlTherapeutic education

Outcome Measures

Primary Outcomes (1)

  • 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 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

    3 months

  • Frequency of acute metabolic events (severe hypoglycaemia or ketoacidosis)

    1 year

  • Frequency of non-severe or symptomatic hypoglycaemia

    1 year

  • Average blood glucose and glycemic variability

    1 year

  • Tolerance of using the device of continuous glucose monitoring (skin tolerance)

    1 year

  • +4 more secondary outcomes

Study Arms (3)

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

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

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).

Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE

Interventions

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).

Group 1Group 2Group 3

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (3)

  • 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.

    PMID: 29923773RESULT

  • 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.

    PMID: 30663187RESULT

  • 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.

    PMID: 31910885RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nadia Tubiana, PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 6, 2023

Record last verified: 2012-07

Locations

FR(1)