Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin

NCT ID: NCT05768191

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-05-01

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Humulin N plus Humulin R

10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals

Group Type: ACTIVE_COMPARATOR

Humulin N plus Humulin R

Intervention Type: DRUG

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

Premix human isophane suspension plus insulin human injection

10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily

Group Type: EXPERIMENTAL

premix insulin human isophane suspension and insulin human

Intervention Type: DRUG

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

Interventions

premix insulin human isophane suspension and insulin human

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

Intervention Type: DRUG

Humulin N plus Humulin R

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female 5 - 18 years of age
• Be diagnosed for at least 1 year at the date of inclusion.
• Have been regular at consultations during the last 12 years preceding inclusion (at least 3 visits)
• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

International Society for Pediatric and Adolescent Diabetes

UNKNOWN

Sponsor Role: collaborator

Société de Médecine Interne du Burkina Faso

UNKNOWN

Sponsor Role: collaborator

Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso

UNKNOWN

Sponsor Role: collaborator

Université NAZI BONI

OTHER

Sponsor Role: lead

Responsible Party

Yempabou Sagna

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Souro Sanou

Bobo-Dioulasso, Houet, Burkina Faso

CHU de Tengandogo

Ouagadougou, Kadiogo, Burkina Faso

CHU Yalgado Ouedraogo

Ouagadougou, Kadiogo, Burkina Faso

Countries

Burkina Faso

Other Identifiers

2023-SOMIBF-01

Identifier Type: -

Identifier Source: org_study_id