Improving Access to HbA1c in Sub Saharan Africa (IA3)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Yaounde Central Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Newcastle University
University of Yaounde 1
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital
ClinicalTrials.gov Identifier:
NCT01460095
First received: October 23, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

Glycated haemoglobin (HbA1c) is the best surrogate of average blood glucose control in diabetic patients. Large-scale studies in the USA and UK have demonstrated that lowering HbA1c significantly reduces diabetes complications. Moreover, immediate feedback of HbA1c measurement to patients improves control. However, HbA1c is unavailable in most parts of Africa, a continent with one of the highest burden of diabetes. To translate these evidences, the investigators will provide affordable access to HbA1c measurement and relevant education in 2 African countries aiming significant improvement of diabetes control. The investigators will develop with local health authorities, training and cost-recovery scheme for long-term sustainability.


Condition Intervention
Diabetes Mellitus
Other: HbA1c measurement and education

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Improving Access to HbA1c Measurement in Sub-Saharan Africa

Resource links provided by NLM:


Further study details as provided by Yaounde Central Hospital:

Primary Outcome Measures:
  • one year change in glycated haemoglobin (HbA1c) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Baseline to 12 months individual change in HbA1c level


Secondary Outcome Measures:
  • One-year change in proportion of patients reaching HbA1c targets [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Baseline to 12 months change in proportion of patients reaching HbA1c targets in each participating centre and in the overall population

  • One-year change in urinary albumin excretion [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Baseline to 12 months individual change in early morning sample urinary albumin excretion


Estimated Enrollment: 1000
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HbA1c measurement and education
3-monthly Hba1c determination with immediate feedback and targeted education delivered to all participants
Other: HbA1c measurement and education
three-monthly point of care measurement of HbA1c with immediate feedback to patients and provision of interpretation and targeted one-to-one education

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diabetes mellitus irrespective of type
  • Patients who have been followed regularly for at least one year prior to inclusion in the target health facilities
  • Adult age (18 years and over)

Exclusion Criteria:

  • Individuals planning to migrate from study sites within one year
  • Any intercurrent acute illness
  • Enrollment in any other concomitant intervention study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460095

Locations
Cameroon
Yaounde Central Hospital
Yaounde, Centre, Cameroon
Bamenda Regional Hospital
Bamenda, North West, Cameroon
Garoua Regional Hospital
Garoua, North, Cameroon
Buea Regional Hospital
Buea, South West, Cameroon
Bafoussam District Hospital
Bafoussam, Cameroon
Guinea
Boke Regional Hospital
Boke, Guinea
CHU Donka
Conakry, Guinea
Kankan Regional Hospital
Kankan, Guinea
Labe regional Hospital
Labe, Guinea
Sponsors and Collaborators
Yaounde Central Hospital
Newcastle University
University of Yaounde 1
Investigators
Principal Investigator: Eugene Sobngwi, MD, PhD Newcastle University, UK and Yaounde Central Hospital, Cameroon
  More Information

No publications provided

Responsible Party: Sobngwi Eugene, Senior Lecturer and Consultant Physician, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT01460095     History of Changes
Other Study ID Numbers: LT07-135
Study First Received: October 23, 2011
Last Updated: October 24, 2011
Health Authority: UK: Newcastle University

Keywords provided by Yaounde Central Hospital:
diabetes
translational research
HbA1c
education

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014