Type 1 DiabetesNCT00308256
Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents
A study testing nurse-counselling in people with Type 1 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- nurse-counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier,
- HbA1c rate > 8 %.
Who cannot join
- HbA1c < 8 %;
- patients participating in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial
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:
Read more
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
- Conditions
- Type 1 Diabetes
- Being tested
- nurse-counselling
- Keywords
- Type1 diabetes;, nurse-counselling;, adolescent
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-counsellingBehavioural
Phone calls performed by nurse 15 days after each monthly visit
| Study group | Role | What they receive |
|---|---|---|
| Nurse counseling | Experimental | Phone calls performed by nurse 15 days after each monthly visit Receives: Behavioral: nurse-counselling |
| Control | No intervention | Normal monthly follow-up without phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's acceptance of the disease evaluated by an analogical visual scale rating
Measured: 12 months
Secondary outcomes (3)
Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin
Measured: 12 months
Number of diabetic acidosis having required hospitalization,
Measured: 12 months
Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc NICOLINO, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308256
- Sponsor's protocol ID
- 2005.395
- Status last verified
- Dec 2025
- First submitted
- 28 Mar 2006
- Last updated
- 19 Dec 2025
- Results posted
- No
Publications
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.
PubMed 26350209
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nurse-counselling in the Improvement of the type1 Diabetes Control in Adolescents: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00308256
- Acronym / sponsor ID
- 2005.395
- Conditions
- Type 1 Diabetes
- Keywords
- Type1 diabetes;, nurse-counselling;, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse counseling | Experimental | Behavioral: nurse-counsellingPhone calls performed by nurse 15 days after each monthly visit |
| Control | No intervention | –Normal monthly follow-up without phone calls |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients aged 13 to 18 years with a type1 diabetes diagnosed at least one year earlier,
- HbA1c rate > 8 %.
Key exclusion criteria (2 listed)
- HbA1c < 8 %;
- patients participating in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-counsellingPhone calls performed by nurse 15 days after each monthly visit | Behavioural | Nurse counseling |
Primary outcome
Patient's acceptance of the disease evaluated by an analogical visual scale rating
Time frame: 12 months
3 secondary outcomes
Glycaemic equilibrium by measuring the rate of glycosylated haemoglobin
Time frame: 12 months
Number of diabetic acidosis having required hospitalization,
Time frame: 12 months
Episodes number of severe hypoglycaemia having required an intervention of a third party or a hospitalization.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 26350209Kassai 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.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc NICOLINO, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-counselling in people with Type 1 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's acceptance of the disease evaluated by an analogical visual scale rating (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00308256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.