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:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT05657769
Brief Summary:
Randomized, unblinded, controlled, two arms parallel group, prospective intervention study
Detailed Description:
The objective of the study is to compare the progression of HbA1c in diabetic patients after applying a Medwell digital application in addition to regular diabetes treatment (treatment arm) with regular diabetes treatment of diabetic subjects alone (control arm).
The primary endpoint will be measured as the difference between 3 months HbA1c relative to baseline in eligible subjects. Normally, HbA1c in each subject is expected to either stable or slightly increase overtime. In this study we are interested in measuring the difference in HbA1c 3 months post randomization. It is expected that in the experimental arm, HbA1c will slightly decrease, while in the standard arm, HbA1c will either remain the same or will slightly increase after 3 months in the study. Previous study shows that the standard deviation of the difference in HbA1c within 1 year is 0.97%.
Study:
NCT05657769
Study Brief:
Protocol Section:
NCT05657769