Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624943
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Impact of Introducing Basaglar a Long-acting Analog Insulin on Clinical and Quality of Life Outcomes in Youth with Diabetes in Mali
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in Mali by switching the insulin regimen from human insulin via needle and syringe to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe
Detailed Description:
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
Long-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
Life for a Child LFAC has been providing diabetes supplies insulin syringes meters and strips for blood glucose self-monitoring diabetes-related education mentoring and technical support to Santé Diabète in Mali since 2008 In 2021 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 Mali one of the worlds poorest countries
Long-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
Life for a Child LFAC has been providing diabetes supplies insulin syringes meters and strips for blood glucose self-monitoring diabetes-related education mentoring and technical support to Santé Diabète in Mali since 2008 In 2021 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 Mali one of the worlds poorest countries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None