Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-02 @ 2:36 AM
Study NCT ID:
NCT01460095
Status:
COMPLETED
Last Update Posted:
2016-04-19
First Post:
2011-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Access to HbA1c in Sub Saharan Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-16', 'studyFirstSubmitDate': '2011-10-23', 'studyFirstSubmitQcDate': '2011-10-24', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one year change in glycated haemoglobin (HbA1c)', 'timeFrame': 'Baseline and 12 months', 'description': 'Baseline to 12 months individual change in HbA1c level'}], 'secondaryOutcomes': [{'measure': 'One-year change in proportion of patients reaching HbA1c targets', 'timeFrame': 'Baseline and 12 months', 'description': 'Baseline to 12 months change in proportion of patients reaching HbA1c targets in each participating centre and in the overall population'}, {'measure': 'One-year change in urinary albumin excretion', 'timeFrame': 'Baseline and 12 months', 'description': 'Baseline to 12 months individual change in early morning sample urinary albumin excretion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes', 'translational research', 'HbA1c', 'education'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The objective is to determine whether the introduction of routine affordable HbA1c determination with immediate feedback to patients and relevant education in an underserved population without any further intervention on drug supply would significantly improve diabetes control. As this will be an after-versus-before type study, each patient will be his own control.\n\nStudy setting The study will be undertaken in 10 existing diabetes care centre in two countries, including 4 regional centers in Guinea, a West African country of 10 millions inhabitants, and 6 regional centers in Cameroon, a Central African country of 18 million inhabitants.\n\nThe health districts covered in Guinea are Conakry, Labe, Kankan and Boke each being situated in a different ecological and cultural areas. In Cameroon, the health districts covered are Biyem Assi in Yaoundé, Garoua, Limbe, Ebolowa, Bamenda, Bafoussam also covering the 4 ecological zone of Cameroon.\n\nAll these health districts have existing diabetes care centre with trained personnel run in public hospital with prices and medicine affordable to most of the population covered. However, none of these centers have an HbA1c machine, and diabetes control is mainly evaluated using blood glucose, most often fasting.\n\nTarget population The aim is to provide the service to all patients followed in the selected centers at low cost however the first eligible 1000 patients will be included in the formal intervention free of charge.\n\nEligibility All patients with a physician-confirmed diagnosis of diabetes and who have been followed in the diabetes centre for at least one year are eligible Sample size In order to detect a difference of 1 unit (1% glycated haemoglobin) between to samples with a standard deviation of 1.2%, alpha coefficient of 0.001 and 0.8 power using a two-sided test, a minimum population of 80 subjects is required. The minimum sample size if alpha is 0.01 is 55 subjects. We therefore decided a sample size of 100 patients per centre in order to be able to analyze data taking into account center or physician effect. It thus give an overall sample size of 1000 subjects.\n\nSampling method We will use a systematic sampling, enrolling consecutive eligible patients volunteering to participate until completion of the sample size in each individual centre.\n\nInclusion All eligible patients, not intending to migrate from the study site within 1 year, and volunteering to participate will be enrolled. At inclusion the following will record of demographic characteristics, past medical history, characteristics of diabetes, evaluation of patient knowledge, and measurement of anthropometric characteristics, blood pressure, haematocrit, HbA1c, and urinary albumin excretion at baseline.\n\nIntervention and follow up:\n\nData will be collected using a clinical record form designated to this effect. The intervention will consist of the measurement of HbA1c at baseline, 3, and 6 months with immediate feedback to patients and provision of targeted education after each determination, on level, significance, and targets.\n\nTreatment will follow usual guidelines with no additional intervention. Adjustment of treatment will be done by the health care personnel in a treat-to-target fashion. No change in drug supply will be introduced. No specific recommendation will be given concerning the frequency of hospital visit between the study visits at baseline, month 3, 6, and 12. Each centre will continue with usual follow up frequency.\n\nAt month 12, we will repeat the evaluation of patient knowledge, and the measurement of anthropometric characteristics, blood pressure, haematocrit, HbA1c, and urinary albumin excretion for comparison to baseline.\n\nTimeframe\n\n* Start date: Month 7\n* End of enrollment: Month 12\n* End of follow-up of last patient enrolled: Month 24\n\nOutcome measures\n\nPrimary outcome: Change in HbA1c from baseline to 12 months\n\nSecondary outcomes:\n\n* Change in percentage of patients at HbA1c target from baseline to 12 months\n* Change in urinary albumin excretion from baseline to 12 months The other measures will serve for the interpretation of data Deliverables\n* Dataset for each centre between Month 24 and Month 26'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diabetes mellitus irrespective of type\n* Patients who have been followed regularly for at least one year prior to inclusion in the target health facilities\n* Adult age (18 years and over)\n\nExclusion Criteria:\n\n* Individuals planning to migrate from study sites within one year\n* Any intercurrent acute illness\n* Enrollment in any other concomitant intervention study'}, 'identificationModule': {'nctId': 'NCT01460095', 'acronym': 'IA3', 'briefTitle': 'Improving Access to HbA1c in Sub Saharan Africa', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Yaounde Central Hospital'}, 'officialTitle': 'Improving Access to HbA1c Measurement in Sub-Saharan Africa', 'orgStudyIdInfo': {'id': 'LT07-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HbA1c measurement and education', 'description': '3-monthly Hba1c determination with immediate feedback and targeted education delivered to all participants', 'interventionNames': ['Other: HbA1c measurement and education']}], 'interventions': [{'name': 'HbA1c measurement and education', 'type': 'OTHER', 'description': 'three-monthly point of care measurement of HbA1c with immediate feedback to patients and provision of interpretation and targeted one-to-one education', 'armGroupLabels': ['HbA1c measurement and education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yaoundé', 'state': 'Centre Region', 'country': 'Cameroon', 'facility': 'Yaounde Central Hospital', 'geoPoint': {'lat': 3.86667, 'lon': 11.51667}}, {'city': 'Garoua', 'state': 'North Region', 'country': 'Cameroon', 'facility': 'Garoua Regional Hospital', 'geoPoint': {'lat': 9.30143, 'lon': 13.39771}}, {'city': 'Bamenda', 'state': 'North-West Region', 'country': 'Cameroon', 'facility': 'Bamenda Regional Hospital', 'geoPoint': {'lat': 5.9597, 'lon': 10.14597}}, {'city': 'Buea', 'state': 'South-West Region', 'country': 'Cameroon', 'facility': 'Buea Regional Hospital', 'geoPoint': {'lat': 4.15342, 'lon': 9.24231}}, {'city': 'Bafoussam', 'country': 'Cameroon', 'facility': 'Bafoussam District Hospital', 'geoPoint': {'lat': 5.47775, 'lon': 10.41759}}, {'city': 'Boké', 'country': 'Guinea', 'facility': 'Boke Regional Hospital', 'geoPoint': {'lat': 10.93217, 'lon': -14.29055}}, {'city': 'Conakry', 'country': 'Guinea', 'facility': 'CHU Donka', 'geoPoint': {'lat': 9.53795, 'lon': -13.67729}}, {'city': 'Kankan', 'country': 'Guinea', 'facility': 'Kankan Regional Hospital', 'geoPoint': {'lat': 10.38542, 'lon': -9.30568}}, {'city': 'Labé', 'country': 'Guinea', 'facility': 'Labe regional Hospital', 'geoPoint': {'lat': 11.31823, 'lon': -12.28332}}], 'overallOfficials': [{'name': 'Eugene Sobngwi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newcastle University, UK and Yaounde Central Hospital, Cameroon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yaounde Central Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Newcastle University', 'class': 'OTHER'}, {'name': 'University of Yaounde 1', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer and Consultant Physician', 'investigatorFullName': 'Sobngwi Eugene', 'investigatorAffiliation': 'Yaounde Central Hospital'}}}}