Improving Access to HbA1c in Sub Saharan Africa (IA3)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1349 participants
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	October 26, 2011
Last Update Posted:	April 19, 2016
Last Verified:	April 2016

Keywords provided by Sobngwi Eugene, Yaounde Central Hospital:

diabetes; translational research; HbA1c; education

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases