NCT05768191CompletedPhase 4
Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 1 Mar 2023
- Start date
- 15 Jun 2023
- Primary completion date
- 15 Apr 2024
- Lead sponsor
- Université NAZI BONI
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05768191
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 22
- From 15 Jun 2023 to the primary completion date, 15 Apr 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- pregnant or lactating females
- opposition to participating in the study
- residing outside the towns where the care centers are located
Who the study is looking for
- 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
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Souro Sanou Coordinator of this site? Confirm its status | Bobo-Dioulasso | Burkina Faso | Unknown status |
| CHU de Tengandogo Coordinator of this site? Confirm its status | Ouagadougou | Burkina Faso | Unknown status |
| CHU Yalgado Ouedraogo Coordinator of this site? Confirm its status | Ouagadougou | Burkina Faso | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.