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Improving Access to HbA1c in Sub Saharan Africa (IA3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01460095
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : April 19, 2016
Newcastle University
University of Yaounde 1
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Other: HbA1c measurement and education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1349 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Improving Access to HbA1c Measurement in Sub-Saharan Africa
Study Start Date : March 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. one year change in glycated haemoglobin (HbA1c) [ Time Frame: Baseline and 12 months ]
    Baseline to 12 months individual change in HbA1c level

Secondary Outcome Measures :
  1. One-year change in proportion of patients reaching HbA1c targets [ Time Frame: Baseline and 12 months ]
    Baseline to 12 months change in proportion of patients reaching HbA1c targets in each participating centre and in the overall population

  2. One-year change in urinary albumin excretion [ Time Frame: Baseline and 12 months ]
    Baseline to 12 months individual change in early morning sample urinary albumin excretion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01460095

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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
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
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Principal Investigator: Eugene Sobngwi, MD, PhD Newcastle University, UK and Yaounde Central Hospital, Cameroon
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Responsible Party: Sobngwi Eugene, Senior Lecturer and Consultant Physician, Yaounde Central Hospital Identifier: NCT01460095    
Other Study ID Numbers: LT07-135
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Sobngwi Eugene, Yaounde Central Hospital:
translational research