Conditions: Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 263
Healthy volunteers: no

Brief summary:
The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.

Detailed description:

Arms:
arm 1: Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks arm 2: Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks

Interventions: intervention 1: Insulin Lispro intervention 2: Huminsulin Regular intervention 3: HumaPen Memoir intervention 4: HumaPen Luxura
Intervention descriptions: intervention 1: subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks intervention 2: subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks intervention 3: subcutaneously, daily for 24 weeks intervention 4: subcutaneously, daily for 24 weeks

Protocol document: