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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768191
• Other study ID #: 2023-SOMIBF-01
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: July 2023
• Source: Université NAZI BONI
• Contact: Yempabou Sagna
• Phone: +22671221937
• Email: my_sagna[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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
• 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

Locations

Country	Name	City	State
Burkina Faso	CHU Souro Sanou	Bobo-Dioulasso	Houet
Burkina Faso	CHU de Tengandogo	Ouagadougou	Kadiogo
Burkina Faso	CHU Yalgado Ouedraogo	Ouagadougou	Kadiogo

Sponsors (5)

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

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	frequency of hypo events (throughout the trial)	weekly frequency of hypo events and time below range	8 months
Secondary	Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.)	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	8 months
Secondary	correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32)		8 months