NCT01425866

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

August 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4.9 years

First QC Date

August 26, 2011

Last Update Submit

January 4, 2024

Conditions

Type 2 Diabetes

Keywords

Diabetes MellitusDiabetes Mellitus, Type 2Structured self-management educationTherapeutic patient educationLifestyle changesSelf-management Blood glucoseEmpowermentAdult learningSocio-constructivismHealth management networkReunion island

Outcome Measures

Primary Outcomes (1)

  • Mean change in glycated haemoglobin (GlyHb)

    0 and 2 years

Secondary Outcomes (14)

  • Mean change in glycated haemoglobin (GlyHb)

    0 and 1 year

  • change in GlyHb

    quarterly up to 2 yrs

  • Blood sugar and lipids

    1 and 2 yrs

  • diabetes complications

    1 and 2 yrs

  • health behaviours

    1 and 2 yrs

  • +9 more secondary outcomes

Study Arms (2)

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).

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.

Behavioral: Structured self-management group education during 2 years

Interventions

Structured self-management group education during 2 yearsBEHAVIORAL

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.

2 years self management educationInitial self-management education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Groupe Hopitalier Est Réunion

Saint-Benoît, La Réunion, 97470, France

Location

Centre Hospitalier Gabriel Martin

Saint-Paul, La Réunion, 97863, France

Location

Diabetolgy - UNiversity Hospital Sud Réunion

Saint-Pierre, La Réunion, 97448, France

Location

Department of endocrinology, University Hospital Reunion Island - Felix Guyon Site

Saint Denis de La Réunion, 97405, France

Location

Related Publications (3)

  • 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.

    PMID: 36510180DERIVED

  • Debussche 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.

    PMID: 35701054DERIVED

  • Debussche 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.

    PMID: 22856504DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusEmpowerment

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Xavier Debussche, MD

    Diabetology - University Hospital Reunion Island - Felix Guyon Site

    PRINCIPAL INVESTIGATOR

  • Jean Luc YVIN, MD

    Department of Internal Medicine - University Hospital Reunion Island - Felix Guyon Site

    PRINCIPAL INVESTIGATOR

  • Stéphane SCHNEEBELI, MD

    Diabetology - University Hospital Reunion Island - GHSR

    PRINCIPAL INVESTIGATOR

  • Jean Hugues GATINA, MD

    Centre Hospitalier Gabriel Martin

    PRINCIPAL INVESTIGATOR

  • Yogananda THIRAPATHIAPPADU, MD

    Groupe Hospitalier Est Réunion

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 30, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

FR(4)