Conget 2010.
| Methods | Multicenter, randomized, controlled, crossover study |
| Participants | Diagnosed with type 1 diabetes mellitus at least 12 months prior to informed consent form; age between 6 and 70 years of age; HbA1c between 7.5% and 9.5%; treated with CSII at least 6 months prior to informed consent. |
| Interventions | INTERVENTION: Paradigm with sensor switched on CONTROL: Paradigm REAL‐Time with sensor switched off |
| Outcomes | PRIMARY: HbA1c level after 6 months of follow‐up SECONDARY: time spent in different glycemic ranges, percentage of patients with HbA1c <7%, number of hypoglycemic events, glucose variability parameters, safety outcomes, treatment satisfaction, and quality of life. |
| Notes | Recruitment occurred between January 2008 and February 2009. A total of 153 patients were randomized. Study completion is anticipated in July 2010. No published results at the time of the search (June 8, 2011). |