Type 1 Diabetes (T1D)Phase 4NCT06624943
Introducing Biosimilar Insulin Glargine to the Treatment Regimen of Children and Youth with Type 1 Diabetes in Mali
A Phase 4 study testing biosimilar insulin glargine in people with Type 1 Diabetes (T1D), run by Life for a Child Program, Diabetes Australia at 1 site in Mali.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- biosimilar insulin glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteMali
- Study dates
- 14 Mar 2022to 5 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with T1D in accordance with World Health Organization criteria
- duration of T1D ≥12 months at time of enrolment
- aged <25 years at time of enrolment
- current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin
- willing to regularly self-monitor blood glucose (SMBG) levels ≥2 times a day with a blood glucose meter and strips
- live in or within one hour's travelling distance of Bamako
Who cannot join
- Previous use of analog insulin
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 world's poorest countries.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- biosimilar insulin glargine
- Keywords
- children, adolescents, insulin glargine, Mali
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biosimilar insulin glargineDrug
Also called Basaglar
Once daily injection of biosimilar insulin glargine via reusable pen
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Continue current treatment with either intermediate- and short-acting human insulin, or pre-mixed insulin, both via needle and syringe |
| Intervention | Experimental | 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 Receives: Drug: biosimilar insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c was measured at each study time point using point of care testing via a Siemens DCA calibrated to international standards (DCA Vantage™ Analyzer (Siemens Healthcare Diagnostics, Tarrytown NY, US)). For HbA1c readings >14% (>130 mmol/mol), the maximum reading of this analyser, HbA1c was recorded as 14% (130 mmol/mol).
Measured: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Secondary outcomes (5)
Episodes of diabetic ketoacidosis
Diabetic ketoacidosis was defined as hyperglycaemia (BGL>11mmol/L/200mg/dL) with a venous pH<7·3 or serum bicarbonate <15mmol/L and ketonuria and/or ketonaemia
Measured: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Episodes of severe hypoglycaemia
Severe hypoglcaemia 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
Measured: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Diabetes Quality of Life in Youth - Short Form
The 21-item Diabetes Quality of Life in Youth - Short Form scale (TC Skinner et al., Diabetologia 2006; 49, 621-628) was administered to participants in both study arms To assess the psychosocial impact of their respective insulin treatment regimens
Measured: Baseline, 6- and 12-month follow-up visits
Participant self-reported satisfaction (intervention arm only)
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
Measured: 12-month follow-up visit
Feedback from local HCPs on implementation of the study intervention
A 6-item questionnaire was administered to HCPs at the end of the study, to obtain feedback on the training they received, their confidence in teaching youth and families on switching to the new insulin regimen, and opinion on its impact on hypo- and hyperglycaemic episodes.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start14 Mar 2022
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life for a Child Program, Diabetes Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Sante Diabete Mali, Hospital of Mali, Centre Hospitalier du Luxembourg, University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Stéphane Besançon, MSC, Principal investigator, ONG Santé Diabète,Bamako,Mali & Unité PACRI,Conservatoire National des Arts et Métiers,Paris,France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624943
- Sponsor's protocol ID
- 2022/27/CE/USTTB
- Other IDs
- #2208-05490
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due local privacy regulations, individual de-identified participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06624943
- Acronym / sponsor ID
- 2022/27/CE/USTTB
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- children, adolescents, insulin glargine, Mali
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Life for a Child Program, Diabetes AustraliaUniversity, hospital or other
- Collaborators
- Sante Diabete Mali, Hospital of Mali, Centre Hospitalier du Luxembourg, University Hospital, Geneva
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 world's poorest countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Continue current treatment with either intermediate- and short-acting human insulin, or pre-mixed insulin, both via needle and syringe |
| Intervention | Experimental | Drug: biosimilar insulin glargineSwitched 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 |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- diagnosed with T1D in accordance with World Health Organization criteria
- duration of T1D ≥12 months at time of enrolment
- aged <25 years at time of enrolment
- current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin
- willing to regularly self-monitor blood glucose (SMBG) levels ≥2 times a day with a blood glucose meter and strips
Key exclusion criteria (1 listed)
- Previous use of analog insulin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biosimilar insulin glargineAlso: BasaglarOnce daily injection of biosimilar insulin glargine via reusable pen | Drug | Intervention |
Primary outcome
HbA1c
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
HbA1c was measured at each study time point using point of care testing via a Siemens DCA calibrated to international standards (DCA Vantage™ Analyzer (Siemens Healthcare Diagnostics, Tarrytown NY, US)). For HbA1c readings >14% (>130 mmol/mol), the maximum reading of this analyser, HbA1c was recorded as 14% (130 mmol/mol).
5 secondary outcomes
Episodes of diabetic ketoacidosis
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Episodes of severe hypoglycaemia
Time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits
Diabetes Quality of Life in Youth - Short Form
Time frame: Baseline, 6- and 12-month follow-up visits
Participant self-reported satisfaction (intervention arm only)
Time frame: 12-month follow-up visit
Feedback from local HCPs on implementation of the study intervention
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No. Due local privacy regulations, individual de-identified participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Besançon, MSC principal investigator
ONG Santé Diabète,Bamako,Mali & Unité PACRI,Conservatoire National des Arts et Métiers,Paris,France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing biosimilar insulin glargine in people with Type 1 Diabetes (T1D), run by Life for a Child Program, Diabetes Australia at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline, 3-, 6-, 9- and 12-month follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.