Type 2 DiabetesERMIESNCT01425866
Two Years Maintenance of Structured Group Self-management Education in Type 2 Diabetes : a Randomized Controlled Trial
A study testing Structured self-management group education during 2 years in people with Type 2 Diabetes, run by Centre Hospitalier Universitaire de la Réunion at 4 sites in France.
Trial summary
Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is efficient in preventing or retarding the complications of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Structured self-management group education during 2 years
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2011to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- HbA1c ≥ 7,5% more than 3 months
- Adults
- ≥ 1 year ADO and/or insulin and/or GLP-1 analog
- antidiabetic treatment unchanged since 3 months (no change of treatment in the last 3 months, except for insulin dosage)
- Living in Reunion Island
- Affiliated to French national health insurance
- Signed informed consent
Who cannot join
- Treatment or associated conditions that would influence glycemic control, such as corticotherapy, cancer, inflammatory chronic diseases
- Hospitalisation linked to diabetes < 3 months
- Structured patient education in the past 3 months
- Severe diabetes complications (e.g. ischemic or proliferative retinopathy, severe renal failure (clearance < 15 ml/min), acute ischemic heart disease (< 6 months, foot lesion)
- Pregnancy (on-going or planned during the study)
- Evolutive cancer
- Physical or cognitive heavy handicap
- Concomitant participation to a therapeutic trial
Trial locations and contacts
4 sites in 1 country.
France4 sites
Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site
Saint Denis de La Réunion, 97405
Groupe Hopitalier Est Réunion
Saint-Benoît, La Réunion, 97470
Centre Hospitalier Gabriel Martin
Saint-Paul, La Réunion, 97863
Diabetolgy - UNiversity Hospital Sud Réunion
Saint-Pierre, La Réunion, 97448
About this study
Official title: Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island
Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is efficient in preventing or retarding the complications of the disease. On Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured group self-management education maintained at the community level for 2 years in patients with insufficiently controlled type 2 diabetes has better metabolic results (as attested by improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months) self-management program, based on the same theoretical basis and framework (learning nests empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2 intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long sessions depending on individual assessment), or a long term program including the same initial program as 1st arm, but with group self management education sessions, maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). Medical visits will be held quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics, tobacco consumption, diabetes complications) and yearly for blood glucose, lipids, micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires), treatment recording, quality of life, self-efficacy, anxiety and depression scales, and social support.
Read the detailed description
Randomised clinical trial comparing 2 parallel arms of educational intervention with the hypothesis of the superiority of a 2-year maintenance of a structured, theoretically-based, educational follow-up. All subjects of both arms will beneficiate from an initial structured educational program (< 3-months). Subjects, educators, and investigators will be unaware of the group allocation during this initial round. Then the intervention arm will undergo a 2 years self management educational follow-up program. Randomisation will be stratified on 2 factors : centres (5 strata) and anti diabetic treatment (2 strata: insulin-treated or not). All group sessions (3-10 subjects, 2 hr-long, one assessment group session and 6 facultative additional specific sessions for each round [initial in both arms or follow-up in the intervention arm], as needed and planned during the first) will be held at the community level, as closer as possible to the subjects' residence. Educators are specifically trained and the educational sessions are structured and coordinated in the framing and organisational supervision of the health management network "ReuCARE" in Reunion island. Subjects of both arms will continue quarterly to attend at the outpatient clinic of the centre. This trial is associated to a qualitative ethno-sociological study on a sample of 30-40 subjects, with in-depth interviews and ethnographic observation of group sessions, with the specific aim of describing the learning processes, coping, health and functional literacy, social and contextual issues.
- Conditions
- Type 2 Diabetes
- Being tested
- Structured self-management group education during 2 years
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Structured self-management education, Therapeutic patient education, Lifestyle changes, Self-management Blood glucose, Empowerment, Adult learning, Socio-constructivism, Health management network, Reunion island
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured self-management group education during 2 yearsBehavioural
After an initial intensive group education, four-monthly follow-up self-management group education sessions for 2 years. Each session is based on empowerment, socio-constructivism, social learning theory: personalized assessment (BG and risk factors, actions: realized, planned, achieved (or not), cognitive work, analysis of individual and social context and environment (facilitators, obstacles) then action planning. Specific additional sessions can be scheduled (food management, diabetes treatment and hypoglycemia, exercise, self monitoring of BG, insulin dosage, foot care). Sessions are framed, and structured, with patient booklet support. Sessions are delivered at the community level, by trained registered nurses, under the coordination of the health management network Reucare.
| Study group | Role | What they receive |
|---|---|---|
| 2 years self management education | Experimental | Long-term program including initial self-management education program (1 to 7 sessions, based on individual assessment), and follow-up group sessions maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). Receives: Behavioral: Structured self-management group education during 2 years |
| Initial self-management education | Active comparator | Initial self-management group education: 1 to 7 sessions (< 3 months), based on individual assessment. Receives: Behavioral: Structured self-management group education during 2 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in glycated haemoglobin (GlyHb)
Measured: 0 and 2 years
Secondary outcomes (14)
Mean change in glycated haemoglobin (GlyHb)
Measured: 0 and 1 year
change in GlyHb
Measured: quarterly up to 2 yrs
Blood sugar and lipids
Blood sugar Total, HDL and LDL cholesterol, triglycerides
Measured: 1 and 2 yrs
diabetes complications
retinopathy stages, micro-albuminuria or proteinuria, creatinine clearance, foot risk grade, ischemic heart or cerebral disease
Measured: 1 and 2 yrs
health behaviours
physical activity and diet (Baecke and food frequency questionnaires)
Measured: 1 and 2 yrs
anti-diabetic therapy
type, dosage
Measured: 1 and 2 yrs
health care process
medical follow-up and appointments, compliance (questionnaire)
Measured: 1 and 2 yrs
Psychometric scales
self-efficacy, social support, HAD (anxiety and depression)
Measured: 1 and 2 yrs
Quality of Life
short DQOL adapted and validated for Reunion
Measured: 1 and 2 yrs
Change in tobacco consumption
Measured: quarterly up to 2 yrs
Change in fasting blood glucose
Measured: quarterly up to 2 yrs
Change in body mass index
Measured: quarterly up to 2 yrs
Change in waist circumference
Measured: quarterly up to 2 yrs
Change in blood pressure
Measured: quarterly up to 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Xavier Debussche, MD, Principal investigator, Diabetology - University Hospital Reunion Island - Felix Guyon SiteJean Luc YVIN, MD, Principal investigator, Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon SiteStéphane SCHNEEBELI, MD, Principal investigator, Diabetology - University Hospital Reunion Island - GHSRJean Hugues GATINA, MD, Principal investigator, Centre Hospitalier Gabriel MartinYogananda THIRAPATHIAPPADU, MD, Principal investigator, Groupe Hospitalier Est Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425866
- Sponsor's protocol ID
- 2010/CHR/03
- Acronym
- ERMIES
- Status last verified
- Jan 2024
- First submitted
- 26 Aug 2011
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Flaus-Furmaniuk A, Fianu A, Lenclume V, Chirpaz E, Balcou-Debussche M, Debussche X, Marimoutou C. Attrition and social vulnerability during 2-year-long structured care in type 2 diabetes, the ERMIES randomized controlled trial. BMC Endocr Disord. 2022 Dec 13;22(1):314. doi: 10.1186/s12902-022-01211-3.
PubMed 36510180Debussche X, Balcou-Debussche M, Ballet D, Caroupin-Soupoutevin J. Health literacy in context: struggling to self-manage diabetes - a longitudinal qualitative study. BMJ Open. 2022 Jun 14;12(6):e046759. doi: 10.1136/bmjopen-2020-046759.
PubMed 35701054Debussche X, Collin F, Fianu A, Balcou-Debussche M, Fouet-Rosiers I, Koleck M, Favier F. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island. Cardiovasc Diabetol. 2012 Aug 2;11:91. doi: 10.1186/1475-2840-11-91.
PubMed 22856504
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Trial of Structured Educational Intervention at the Community Level in Insufficiently Controlled Patients With Type 2 Diabetes in Reunion Island
- ClinicalTrials.gov ID
- NCT01425866
- Acronym / sponsor ID
- ERMIES / 2010/CHR/03
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Structured self-management education, Therapeutic patient education, Lifestyle changes, Self-management Blood glucose, Empowerment, Adult learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Oct 2011 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Aug 2011 (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.
Type 2 diabetes has a growing impact on populations and public health worldwide. Clinical trials have clearly demonstrated that a better control of blood glucose level and of other risk factors is efficient in preventing or retarding the complications of the disease. On Reunion island, Type 2 diabetes is present in 18% of population aged 30 or older with a high level of socio-economic deprivation. The hypothesis of the ERMIES study is that a structured group self-management education maintained at the community level for 2 years in patients with insufficiently controlled type 2 diabetes has better metabolic results (as attested by improvement in HbA1c level) at 2 yrs, compared to an initial short term (< 3 months) self-management program, based on the same theoretical basis and framework (learning nests empowerment). A total of 240 adults living in Reunion Island, with type 2 diabetes mellitus with HbA1c ≥ 7.5% on a stable treatment for at least 3 months will be randomly allocated to 2 intervention arms: either a short term (< 3 months) program (1 to 7 thematic 2-hr long sessions depending on individual assessment), or a long term program including the same initial program as 1st arm, but with group self management education sessions, maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). Medical visits will be held quarterly for the recording of outcome measures (HbA1c, blood pressure, anthropometrics, tobacco consumption, diabetes complications) and yearly for blood glucose, lipids, micro-albuminuria or proteinuria, creatinine clearance, diet and exercise (questionnaires), treatment recording, quality of life, self-efficacy, anxiety and depression scales, and social support.
Detailed description
Randomised clinical trial comparing 2 parallel arms of educational intervention with the hypothesis of the superiority of a 2-year maintenance of a structured, theoretically-based, educational follow-up. All subjects of both arms will beneficiate from an initial structured educational program (< 3-months). Subjects, educators, and investigators will be unaware of the group allocation during this initial round. Then the intervention arm will undergo a 2 years self management educational follow-up program. Randomisation will be stratified on 2 factors : centres (5 strata) and anti diabetic treatment (2 strata: insulin-treated or not). All group sessions (3-10 subjects, 2 hr-long, one assessment group session and 6 facultative additional specific sessions for each round [initial in both arms or follow-up in the intervention arm], as needed and planned during the first) will be held at the community level, as closer as possible to the subjects' residence. Educators are specifically trained and the educational sessions are structured and coordinated in the framing and organisational supervision of the health management network "ReuCARE" in Reunion island. Subjects of both arms will continue quarterly to attend at the outpatient clinic of the centre. This trial is associated to a qualitative ethno-sociological study on a sample of 30-40 subjects, with in-depth interviews and ethnographic observation of group sessions, with the specific aim of describing the learning processes, coping, health and functional literacy, social and contextual issues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 years self management education | Experimental | Behavioral: Structured self-management group education during 2 yearsLong-term program including initial self-management education program (1 to 7 sessions, based on individual assessment), and follow-up group sessions maintained for 2 years (4-monthly assessment, empowerment, and contextual action planning; facultative additional specific thematic sessions being delivered if needed). |
| Initial self-management education | Active comparator | Behavioral: Structured self-management group education during 2 yearsInitial self-management group education: 1 to 7 sessions (< 3 months), based on individual assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes
- HbA1c ≥ 7,5% more than 3 months
- Adults
- ≥ 1 year ADO and/or insulin and/or GLP-1 analog
- antidiabetic treatment unchanged since 3 months (no change of treatment in the last 3 months, except for insulin dosage)
Key exclusion criteria (8 listed)
- Treatment or associated conditions that would influence glycemic control, such as corticotherapy, cancer, inflammatory chronic diseases
- Hospitalisation linked to diabetes < 3 months
- Structured patient education in the past 3 months
- Severe diabetes complications (e.g. ischemic or proliferative retinopathy, severe renal failure (clearance < 15 ml/min), acute ischemic heart disease (< 6 months, foot lesion)
- Pregnancy (on-going or planned during the 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 |
|---|---|---|
| Structured self-management group education during 2 yearsAfter an initial intensive group education, four-monthly follow-up self-management group education sessions for 2 years. Each session is based on empowerment, socio-constructivism, social learning theory: personalized assessment (BG and risk factors, actions: realized, planned, achieved (or not), cognitive work, analysis of individual and social context and environment (facilitators, obstacles) then action planning. Specific additional sessions can be scheduled (food management, diabetes treatment and hypoglycemia, exercise, self monitoring of BG, insulin dosage, foot care). Sessions are framed, and structured, with patient booklet support. Sessions are delivered at the community level, by trained registered nurses, under the coordination of the health management network Reucare. | Behavioural | 2 years self management education, Initial self-management education |
Primary outcome
Mean change in glycated haemoglobin (GlyHb)
Time frame: 0 and 2 years
14 secondary outcomes
Mean change in glycated haemoglobin (GlyHb)
Time frame: 0 and 1 year
change in GlyHb
Time frame: quarterly up to 2 yrs
Blood sugar and lipids
Time frame: 1 and 2 yrs
diabetes complications
Time frame: 1 and 2 yrs
health behaviours
Time frame: 1 and 2 yrs
anti-diabetic therapy
Time frame: 1 and 2 yrs
health care process
Time frame: 1 and 2 yrs
Psychometric scales
Time frame: 1 and 2 yrs
Quality of Life
Time frame: 1 and 2 yrs
Change in tobacco consumption
Time frame: quarterly up to 2 yrs
Change in fasting blood glucose
Time frame: quarterly up to 2 yrs
Change in body mass index
Time frame: quarterly up to 2 yrs
Change in waist circumference
Time frame: quarterly up to 2 yrs
Change in blood pressure
Time frame: quarterly up to 2 yrs
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 5 Jan 2024.
- Derived from this study: PubMed 36510180Flaus-Furmaniuk A, Fianu A, Lenclume V, Chirpaz E, Balcou-Debussche M, Debussche X, Marimoutou C. Attrition and social vulnerability during 2-year-long structured care in type 2 diabetes, the ERMIES randomized controlled trial. BMC Endocr Disord. 2022 Dec 13;22(1):314. doi: 10.1186/s12902-022-01211-3.
- Derived from this study: PubMed 35701054Debussche X, Balcou-Debussche M, Ballet D, Caroupin-Soupoutevin J. Health literacy in context: struggling to self-manage diabetes - a longitudinal qualitative study. BMJ Open. 2022 Jun 14;12(6):e046759. doi: 10.1136/bmjopen-2020-046759.
- Derived from this study: PubMed 22856504Debussche X, Collin F, Fianu A, Balcou-Debussche M, Fouet-Rosiers I, Koleck M, Favier F. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island. Cardiovasc Diabetol. 2012 Aug 2;11:91. doi: 10.1186/1475-2840-11-91.
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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.
Xavier Debussche, MD principal investigator
Diabetology - University Hospital Reunion Island - Felix Guyon Site
Jean Luc YVIN, MD principal investigator
Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon Site
Stéphane SCHNEEBELI, MD principal investigator
Diabetology - University Hospital Reunion Island - GHSR
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured self-management group education during 2 years in people with Type 2 Diabetes, run by Centre Hospitalier Universitaire de la Réunion at 4 sites 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 8 inclusion and 8 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Mean change in glycated haemoglobin (GlyHb) (time frame: 0 and 2 years). 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 NCT01425866, which also lists 3 linked publications.
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 5 Jan 2024.