Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06674135
Status:
COMPLETED
Last Update Posted:
2024-11-07
First Post:
2024-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2024-11-03', 'studyFirstSubmitQcDate': '2024-11-03', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean and median HbA1c (% and mmol/mol)', 'timeFrame': 'Baseline, 3-, 6-, 9- and 12-month follow-up visits', 'description': 'HbA1c was measured at each study time point using the Minicap Sebia Autoanalyzer with venous blood'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants experiencing episodes of diabetic ketoacidosis', 'timeFrame': 'Baseline, 3-, 6-, 9- and 12-month follow-up visits', 'description': 'Diabetic ketoacidosis was defined as hyperglycaemia (BGL\\>11mmol/L/200mg/dL) with a venous pH\\<7·3 or serum bicarbonate \\<15mmol/L and ketonaemia and ketonuria'}, {'measure': 'Proportion of participants experiencing episodes of severe hypoglycaemia', 'timeFrame': 'Baseline, 3-, 6-, 9- and 12-month follow-up visits', 'description': 'Severe hypoglycaemia was defined as an event with severe cognitive impairment (with or without coma and convulsions) requiring assistance by another person to administer carbohydrates, glucagon, or intravenous dextrose to restore glycaemia'}, {'measure': 'Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)', 'timeFrame': 'Baseline, 6- and 12-month follow-up visits', 'description': 'The 21- item Diabetes Quality of Life in Youth - Short Form scale \\[1\\] was administered to participants to assess their health-related quality of life after the change in their insulin treatment regimen.\n\nEach item has 5 possible scores with a value from 0 to 4, with 0 representing "never" and 4 "all the time". Higher scores represent a higher impact of diabetes and a poorer quality of life; lower scores indicate greater quality of life. The highest possible score is 84 (21 x 4 i.e. "all the time" for all 21 items) and lowest possible score is 0 (21 x 0 i.e. "never" for all 21 items)'}, {'measure': 'Participant self-reported satisfaction', 'timeFrame': '12-month follow-up visit', 'description': 'A 5-item structured questionnaire was administered to participants in the intervention group to evaluate their satisfaction with the new insulin regimen, experience of using reusable insulin pens, and their experience of hypo- and hyperglycaemic episodes over the study period'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Analog insulin', 'Basaglar', 'Bangladesh', 'Children and Adolescents', 'Type 1 diabetes', 'insulin pen-devices'], 'conditions': ['Type I Diabetes']}, 'referencesModule': {'references': [{'pmid': '16525844', 'type': 'BACKGROUND', 'citation': 'Skinner TC, Hoey H, McGee HM, Skovlund SE; Hvidore Study Group on Childhood Diabetes. A short form of the Diabetes Quality of Life for Youth questionnaire: exploratory and confirmatory analysis in a sample of 2,077 young people with type 1 diabetes mellitus. Diabetologia. 2006 Apr;49(4):621-8. doi: 10.1007/s00125-005-0124-0. Epub 2006 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Bangladesh', 'detailedDescription': 'Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings.\n\nLong-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries.\n\nLife for a Child (LFAC) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (T1D) managed at the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) Hospital in Dhaka, Bangladesh. In 2022, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll). This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low-resource setting of Bangladesh.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 1 diabetes (T1D). Diabetes was diagnosed in accordance with World Health Organization (WHO) criteria. Determination of diabetes type was made by the local investigators according to available clinical features and history: T1D was diagnosed upon abrupt onset of typical symptoms of diabetes with insulin required from diagnosis, and no acanthosis nigricans. They were usually non-obese.\n* Duration of T1D at enrolment \\>12 months\n* Aged 10-25 years (inclusive) at time of enrolment\n* Current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin\n* Attending Life for a Child, BIRDEM Hospital, Dhaka for their usual diabetes care\n\nExclusion Criteria:\n\n• Previous use of analog insulin'}, 'identificationModule': {'nctId': 'NCT06674135', 'briefTitle': 'Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'Life for a Child Program, Diabetes Australia'}, 'officialTitle': 'Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh', 'orgStudyIdInfo': {'id': 'BADAS-ERC/EC/22/00325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Introduction of Basaglar to insulin treatment regimen', 'description': 'Switched to once daily injection of biosimilar insulin glargine via reusable pen and three mealtime bolus insulin injections of short-acting human insulin via needle and syringe', 'interventionNames': ['Drug: biosimilar insulin glargine']}], 'interventions': [{'name': 'biosimilar insulin glargine', 'type': 'DRUG', 'otherNames': ['Basaglar'], 'description': 'Switched to once daily injection of biosimilar insulin glargine via reusable pen and three mealtime bolus insulin injections of short-acting human insulin via needle and syringe', 'armGroupLabels': ['Introduction of Basaglar to insulin treatment regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'BIRDEM, the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Dr Bedowra Zabeen, MBBS, FCPS(Paediatrics), FRSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Life For a Child Program, BIRDEM, BADAS, Bangladesh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due local privacy regulations, individual de-identified participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Life for a Child Program, Diabetes Australia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders', 'class': 'OTHER'}, {'name': 'BADAS-Centre for Health Research and Implementation', 'class': 'UNKNOWN'}, {'name': 'Diabetic Association of Bangladesh (BADAS)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}