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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03369067
Brief Summary:
An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.
Detailed Description:
This proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and assess usability in a supervised setting in a controlled environment compared with state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes (T1D) in adolescents. Phase 1 participants (13-18 years old) and Phase 2 participants (6-12 years old) will be assessed during a \~48 hour ski camp; Upon completion of the ski camp, Phase 2 participants (6-12 years old) will also be assessed during a \~78 hour home use.
Study:
NCT03369067
Study Brief:
Protocol Section:
NCT03369067