Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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.
Sites / Locations
- CHU Souro SanouRecruiting
- CHU de TengandogoRecruiting
- CHU Yalgado OuedraogoRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Humulin N plus Humulin R
Premix human isophane suspension plus insulin human injection
10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals
10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily