Improving Access to HbA1c in Sub Saharan Africa (IA3)

This study has been completed.

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: April 16, 2016

Last verified: April 2016

History of Changes

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

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


Enrollment:	1349
Study Start Date:	March 2009
Study Completion Date:	December 2011
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 (Adult, Senior)
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

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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


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:	April 16, 2016
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 September 28, 2016

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