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. |
| ClinicalTrials.gov Identifier: NCT01460095 |
|
Recruitment Status :
Completed
First Posted : October 26, 2011
Last Update Posted : April 19, 2016
|
Sponsor:
Yaounde Central Hospital
Collaborators:
Newcastle University
University of Yaounde 1
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Show Detailed Description
| 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 |
| 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 :
- 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 :
- 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
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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 ClinicalTrials.gov identifier (NCT number): 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 |
| 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 Key Record Dates |
| 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 |