Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00949221
First received: July 29, 2009
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Device: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Frequency of acute metabolic events (severe hypoglycaemia or ketoacidosis) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Frequency of non-severe or symptomatic hypoglycaemia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Average blood glucose and glycemic variability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Tolerance of using the device of continuous glucose monitoring (skin tolerance) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acceptability of the device (percentage of time of use) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • General and diabetes-related Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Satisfaction to use the device [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Medico-economic evaluation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: 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).
Other Name: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE
Group 2
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 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).
Other Name: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE
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).
Device: 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).
Other Name: monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949221

Locations
France
Hôpital Robert Debré
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nadia Tubiana, PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00949221     History of Changes
Other Study ID Numbers: P070152, 2007-A01330-53
Study First Received: July 29, 2009
Last Updated: July 26, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Type 1 diabetes
Paediatric
Real Time Continuous Glucose Monitoring
Glycemic control
Therapeutic education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014