Type 1 DiabetesEVAUTODIABNCT02272348
Self-management of Type 1 Diabetes Under Functional Insulin Therapy
A study testing Training course to functional insulin therapy and Usual diabetes management. in people with Type 1 Diabetes and Basal-bolus Multiple-dily Insulin Injections, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Therapeutic education of patients is a mandatory component of intensive insulin therapy of type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim at facilitating patients' autonomy in their own management of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Basal-bolus Multiple-dily Insulin Injections, Insulin Pump (CSII)
- What is being tested?
- Training course to functional insulin therapy and Usual diabetes management.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2015to 10 Sep 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes from at least 1 year
- Age from 18 to 70 (70 not included)
- Basal-bolus multiple-dily insulin injections or insulin pump (CSII)
- Informed consent
- Affiliated or benefit from an insurance regimen
Who cannot join
- Type 2 diabetes
- Unable to make mathematic calculation
- Pregnancy, breast-feeding or absence of effective contraception
- Psychiatric and/or cognitive status uncompatible with study
- Eating disorders
- Law protected person, vulnerable person
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy
Therapeutic education of patients is a mandatory component of intensive insulin therapy of type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim at facilitating patients' autonomy in their own management of diabetes. Therefore, self-management of patient with type 1 diabetes must be systematically assessed in order to evaluate the effectiveness of education programs .The main objective of this prospective controlled randomized monocentric study is to assess the impact of functional insulin therapy on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes Self-care scale (CIDS) test.
Read the detailed description
170 patients with type 1 diabetes, volunteering for education to functional insulin therapy, will be recruited by the Department od Endocrinology, Diabetes, Nutrition of Montpellier University Hospital.
After inclusion, the patients will be randomized in 2 groups: group 1 will be immediately trained to functional insulin therapy and group 2 will be trained at the end of the study. The patients will be met as outpatients 3 months after inclusion. The primary endpoint will be the global score for CIDS questionnaire.
Secondary endpoints will include: HbA1c level at month 3, frequency of hypoglycemia from inclusion to month 3, scores for each of the 20 items of CIDS questionnaire.
An ancillary study will assess: the acceptability of the new EAD questionnaire which specifically evaluates the self-management of diabetes, the concordance validity of EAD and CDIS questionnaires, the reproducibility test-retest, the internal consistency and the sensitivity to change of EAD questionnaire.
- Being tested
- Training course to functional insulin therapy, Usual diabetes management.
- Keywords
- Therapeutic education, Functional insulin therapy
- 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.
Training course to functional insulin therapyOther
Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor
Usual diabetes management.Other
| Study group | Role | What they receive |
|---|---|---|
| Education to functional insulin therapy immediately | Experimental | Immediately after inclusion, patients will follow a functional insulin therapy training course during 2.5 days. Receives: Other: Training course to functional insulin therapy |
| No education to functional insulin therapy immediately | Other | After inclusion in the study, patients go on usual diabetes management. At the end of study, they will receive education to functional insulin therapy. Receives: Other: Usual diabetes management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management.
CIDS questionnaire
Measured: three months (from inclusion until end of study)
Secondary outcomes (4)
To assess the effect of education to functional insulin therapy on HbA1c level
HbA1c
Measured: three months (from inclusion until end of study)
To assess the effect of education to functional insulin therapy on hypoglycemia frequency
Hypoglycemia occurrence
Measured: three months (from inclusion until end of study)
To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire
CIDS questionnaire sub scores
Measured: three months (from inclusion until end of study)
To assess the validity, the concordance and the sensitivity to change of EAD questionnaire (specific for self-management of diabetes) in comparison with CIDS test
EAD questionnaire score
Measured: three months (from inclusion until end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start10 Feb 2015
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Why it stopped: Change in methodology too important - end of randomization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise DUTERTRE, MD, Principal investigator, CHU Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272348
- Sponsor's protocol ID
- 9372
- Acronym
- EVAUTODIAB
- Status last verified
- Dec 2021
- First submitted
- 20 Oct 2014
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Self-management of Patients With Type 1 Diabetes After Education to Functional Insulin Therapy
- ClinicalTrials.gov ID
- NCT02272348
- Acronym / sponsor ID
- EVAUTODIAB / 9372
- Keywords
- Therapeutic education, Functional insulin therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in methodology too important - end of randomization
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Feb 2015 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 22 Oct 2014 (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.
Therapeutic education of patients is a mandatory component of intensive insulin therapy of type 1 diabetes in order to reach optimal safety and efficacy. Used educational methods aim at facilitating patients' autonomy in their own management of diabetes. Therefore, self-management of patient with type 1 diabetes must be systematically assessed in order to evaluate the effectiveness of education programs .The main objective of this prospective controlled randomized monocentric study is to assess the impact of functional insulin therapy on the level of self-management of patients with type 1 diabetes via Confidence In Diabetes Self-care scale (CIDS) test.
Detailed description
170 patients with type 1 diabetes, volunteering for education to functional insulin therapy, will be recruited by the Department od Endocrinology, Diabetes, Nutrition of Montpellier University Hospital.
After inclusion, the patients will be randomized in 2 groups: group 1 will be immediately trained to functional insulin therapy and group 2 will be trained at the end of the study. The patients will be met as outpatients 3 months after inclusion. The primary endpoint will be the global score for CIDS questionnaire.
Secondary endpoints will include: HbA1c level at month 3, frequency of hypoglycemia from inclusion to month 3, scores for each of the 20 items of CIDS questionnaire.
An ancillary study will assess: the acceptability of the new EAD questionnaire which specifically evaluates the self-management of diabetes, the concordance validity of EAD and CDIS questionnaires, the reproducibility test-retest, the internal consistency and the sensitivity to change of EAD questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education to functional insulin therapy immediately | Experimental | Other: Training course to functional insulin therapyImmediately after inclusion, patients will follow a functional insulin therapy training course during 2.5 days. |
| No education to functional insulin therapy immediately | Other | Other: Usual diabetes management.After inclusion in the study, patients go on usual diabetes management. At the end of study, they will receive education to functional insulin therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes from at least 1 year
- Age from 18 to 70 (70 not included)
- Basal-bolus multiple-dily insulin injections or insulin pump (CSII)
- Informed consent
- Affiliated or benefit from an insurance regimen
Key exclusion criteria (6 listed)
- Type 2 diabetes
- Unable to make mathematic calculation
- Pregnancy, breast-feeding or absence of effective contraception
- Psychiatric and/or cognitive status uncompatible with study
- Eating disorders
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 |
|---|---|---|
| Training course to functional insulin therapyCarbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor | Other | Education to functional insulin therapy immediately |
| Usual diabetes management. | Other | No education to functional insulin therapy immediately |
Primary outcome
To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management.
Time frame: three months (from inclusion until end of study)
CIDS questionnaire
4 secondary outcomes
To assess the effect of education to functional insulin therapy on HbA1c level
Time frame: three months (from inclusion until end of study)
To assess the effect of education to functional insulin therapy on hypoglycemia frequency
Time frame: three months (from inclusion until end of study)
To assess the effect of education to functional insulinotherapy on the score of each of the 20 items of CIDS questioonaire
Time frame: three months (from inclusion until end of study)
To assess the validity, the concordance and the sensitivity to change of EAD questionnaire (specific for self-management of diabetes) in comparison with CIDS test
Time frame: three months (from inclusion until end of study)
Results and safety
The study was stopped early (reason given: Change in methodology too important - end of randomization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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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.
Elise DUTERTRE, MD principal investigator
CHU Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training course to functional insulin therapy and Usual diabetes management. in people with Type 1 Diabetes and Basal-bolus Multiple-dily Insulin Injections, run by University Hospital, Montpellier 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Dec 2021. 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 was stopped early (reason given: Change in methodology too important - end of randomization). Results are not available in the source record.
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?
To assess the impact of therapeutic education by functional insulin therapy in patients with type 1 diabetes on their ability to disease self-management. (time frame: three months (from inclusion until end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2021.