NCT00308256

Brief Summary

The incidence of type 1 diabetes is increasing in France. A recent cross sectional study has shown that in France, only 15% of children and 26% of adults had HbA1c\<7%. Adolescents seem to need particularly a better metabolic control. Working Hypothesis: We hypothesized that a stricter control of glycaemia by nurse-counselling could probably improve metabolic control in adolescents with type 1 diabetes. Objectives: To show that nurse-counselling may improve levels of patient satisfaction. Methodology: The main criterion is the patient acceptance of diabetes measured by an analogical visual scale rated from 0 (I cope very well with my diabetes, I cope very badly with my diabetes) to 10 cm. The scale will be measured every quarter within 12 months follow-up. We wish to improve patient's appreciation by 10 mm, near to "I cope very well with my diabetes". This is a randomised parallel group study with 36 subjects in each group. During the follow-up, the "routine follow-up" group will continue its routine care. The "complementary follow-up" group will be called by nurses every 15 days and consult monthly. HbA1c is the secondary criterion and will be measured every 3 months. The total study duration is 18 months including 6 months for the recruitment and 12 months for the patients follow-up

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5.4 years

First QC Date

March 28, 2006

Last Update Submit

December 13, 2025

Conditions

Type 1 Diabetes

Keywords

Type1 diabetes;nurse-counselling;adolescent

Outcome Measures

Primary Outcomes (1)

  • Patient's acceptance of the disease evaluated by an analogical visual scale rating

    12 months

Secondary Outcomes (3)

  • Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin

    12 months

  • Number of diabetic acidosis having required hospitalization,

    12 months

  • Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.

    12 months

Study Arms (2)

Nurse counseling

EXPERIMENTAL

Phone calls performed by nurse 15 days after each monthly visit

Behavioral: nurse-counselling

Control

NO INTERVENTION

Normal monthly follow-up without phone calls

Interventions

nurse-counsellingBEHAVIORAL

Phone calls performed by nurse 15 days after each monthly visit

Nurse counseling

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier,
  • HbA1c rate \> 8 %.

You may not qualify if:

  • HbA1c \< 8 %;
  • patients participating in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marc Nicolino

Lyon, 69005, France

Location

Related Publications (1)

  • Kassai B, Rabilloud M, Bernoux D, Michal C, Riche B, Ginhoux T, Laudy V, Terral D, Didier-Wright C, Maire V, Dumont C, Cottancin G, Plasse M, Jeannoel GP, Khoury J, Bony C, Lievre M, Drai J, Nicolino M. Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial. Trials. 2015 Sep 8;16:399. doi: 10.1186/s13063-015-0923-7.

    PMID: 26350209RESULT

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

  • Marc NICOLINO, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)