Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin
1 other identifier
interventional
22
1 country
3
Brief Summary
The goal of this clinical trial is to compare glycemic control and variability between children and adolescents with type 1 diabetes treated by a two daily injection of premixed human insulin (Humulin 30/70) and those who have a basal bolus scheme (Humulin N + Humulin R) in a resources limited setting. The main question it aims to answer is: what is the effectiveness of premixed human insulin on glycemic control? Ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals. At the end of the initial 16-wk treatment (period 1), all patients will be crossed over to the alternate treatment arm for an additional 16 wk (period 2). Insulin doses will be adjusted weekly by the clinical site according to a prespecified insulin intensification algorithm to achieve target fasting \[\<110 mg/dl (6.1 mmol/liter)\], bedtime \[\<130 mg/dl (7.2 mmol/liter)\], and premeal \[\<110 mg/dl (6.1 mmol/liter)\] glucose levels until HbA1c was below 7.0%. Subjects will receive training on the FreeStyle Libre CGMS System, electronic hand-held personal digital assistant (e-diary), and self-monitoring of blood glucose (SMBG), including recording glucose, insulin doses, and symptoms of hypo- or hyperglycemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2023
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 14, 2023
CompletedStudy Start
First participant enrolled
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedDecember 12, 2024
December 1, 2024
10 months
March 1, 2023
December 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To compare improvements from baseline in patient HbA1c when aggressively treated with insulin human isophane plus rapid acting human insulin vs treatment with Premix human insulin
12 months
Secondary Outcomes (3)
frequency of hypo events (throughout the trial)
8 months
Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.)
8 months
correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32)
8 months
Study Arms (2)
Humulin N plus Humulin R
ACTIVE COMPARATOR10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals
Premix human isophane suspension plus insulin human injection
EXPERIMENTAL10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily
Interventions
Sequence (Premix first, then Humulin N + Humulin R): Subjects randomized to this sequence will receive premix insulin, twice per day for 16 weeks. After the first 16 weeks, subjects will cross over to the Humulin N plus Humulin R sequence for a further treatment of 16 weeks
Sequence (Humulin N + Humulin R first, then Premix): Subjects randomized to this sequence will receive basal bolus insulin scheme with Humulin N (twice daily) and Humulin R (before meals) for 16 weeks. After the first 16 weeks, subjects will cross over to the Premix sequence for a further treatment of 16 weeks
Eligibility Criteria
You may qualify if:
- Male or female 5 - 18 years of age
- Willing and able to inject insulin human isophane and multi-day dosing of rapid acting human insulin.
- Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study
- Have (patient or guardian) a minimum 4 years primary school level
- Have (patient or guardian) a connected cellphone that can install the free FreeStyle link application and use connected messaging app
You may not qualify if:
- pregnant or lactating females
- opposition to participating in the study
- residing outside the towns where the care centers are located
- Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CHU Souro Sanou
Bobo-Dioulasso, Houet, Burkina Faso
CHU de Tengandogo
Ouagadougou, Kadiogo, Burkina Faso
CHU Yalgado Ouedraogo
Ouagadougou, Kadiogo, Burkina Faso
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 14, 2023
Study Start
June 15, 2023
Primary Completion
April 15, 2024
Study Completion
May 1, 2024
Last Updated
December 12, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR