Clinical trial NCT05768191: Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: Université NAZI BONI
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: International Society for Pediatric and Adolescent Diabetes
name: Société de Médecine Interne du Burkina Faso
name: Association pour la Formation, la Recherche et l'Education sur le Diabète, Burkina Faso
First posted: 2023-03-14
Enrollment: 22
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: frequency of hypo events (throughout the trial)
timeFrame: 8 months
measure: Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.)
timeFrame: 8 months
measure: correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32)
timeFrame: 8 months
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: CHU Souro Sanou
state: Houet
city: Ouagadougou
country: Burkina Faso
facility: CHU de Tengandogo
state: Kadiogo
city: Ouagadougou
country: Burkina Faso
facility: CHU Yalgado Ouedraogo
state: Kadiogo
Study officials:
References: