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

Sponsor

Université NAZI BONI (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05768191

Collaborator

Juvenile Diabetes Research Foundation (Other), International Society for Pediatric and Adolescent Diabetes (Other), Société de Médecine Interne du Burkina Faso (Other), Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso (Other)

Enrollment

Locations

Arms

9.5

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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? Thirty participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 30 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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: premix insulin human isophane suspension and insulin human Drug: Humulin N plus Humulin R	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin in a Limited Resources Setting: a Multicenter Randomized Controlled Crossover Clinical Trial

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Humulin N plus Humulin R 15 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals	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
Experimental: Premix human isophane suspension plus insulin human injection 15 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily	Drug: 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

Arm

Intervention/Treatment

Active Comparator: Humulin N plus Humulin R

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

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

Experimental: Premix human isophane suspension plus insulin human injection

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

Drug: 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

frequency of hypo events (throughout the trial) [8 months]
weekly frequency of hypo events and time below range
Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.) [8 months]
The PedsQL 3.2 Diabetes Module is composed of 33 items comprising 5 dimensions for ages 8- 45 years and 32 items for ages 2-7 years. Items are reversed scored and linearly transformed to a 0-100 scale. Higher scores indicate lower problems
correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32) [8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	CHU Souro Sanou	Bobo-Dioulasso	Houet	Burkina Faso
2	CHU de Tengandogo	Ouagadougou	Kadiogo	Burkina Faso
3	CHU Yalgado Ouedraogo	Ouagadougou	Kadiogo	Burkina Faso

Sponsors and Collaborators

Université NAZI BONI
Juvenile Diabetes Research Foundation
International Society for Pediatric and Adolescent Diabetes
Société de Médecine Interne du Burkina Faso
Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso