Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT00942318
Brief Summary:
A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin infusion (CSII), using an external pump, could be a solution to improve diabetes control.
The aim of this study is to compare, over a one-year period, the efficacy of CSII (with aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c\>7 -10%).
Detailed Description:
Visit 1: patient information and eligibility criteria assessment Visit 2: Inform consent signature and randomisation (group CSII or MDI). Patients randomised in the CSII group are instructed to use pump between V2 and V3.
Visit 3: 5-day's hospitalisation. Start of CSII or MDI treatments. Stop of all oral diabetic medications except for metformin, which is followed up until the end of the study. Teaching program on diabetes management (diet, physical activity and self-adjustment of insulin doses). HbA1c, clinical and biological parameters. Questionnaires.
Follow-up visits 4-7 (1, 3, 6, 9 months): HbA1c. Treatment adjustment. Adverse events collection.
Final visit (12 months): HbA1c, clinical and biological parameters. Questionnaires. Adverse events collection.
Study:
NCT00942318
Study Brief:
Protocol Section:
NCT00942318