Description Module

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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 1:27 AM
NCT ID: NCT03263494
Brief Summary: Adolescents and young adults with T1D and poor glycemic control (age 14-\< 25 years, T1D duration \>12 months, HbA1c 7.5-\<11.0%, using an insulin pump or MDI)) will be randomly assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial will be followed by a 6-month extension study during which the RCT control group will initiate CGM and the RCT CGM group will continue CGM.
Study: NCT03263494
Study Brief:
Protocol Section: NCT03263494