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 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT07128992
Brief Summary:
This prospective study evaluates the safety of extending the interval of routine calendar-based follow-up visits from every 12 months to every 24 months in patients with type 1 diabetes who are in good glycemic control and suitable for remote monitoring. The primary outcome is the proportion of patients who maintain good glycemic control during the 24-month follow-up period.
Participants will attend two in-person visits at baseline (month 0) and at the end of follow-up (month 24), which include a comprehensive clinical examination, assessment of glucose control, and laboratory testing. One remote contact will occur at month 12 for prescription renewal and review of glucose data. Patients may contact their care unit as needed throughout the study. At the baseline and final visits, participants will complete a questionnaire assessing their perceived ability to manage self-care, the safety of the care plan, and their ability to contact their care provider when necessary.
Detailed Description:
The primary outcome of this study is the proportion of patients who maintain good glycemic control during the 24-month follow-up period. A clinically significant result is defined as no more than 14% of patients (95% confidence interval: 8%-20%) experiencing deterioration in glucose control, indicated by Time in Range (TIR) \< 70% or HbA1c \> 53 mmol/mol. If at least 125 patients are enrolled, need-based care can be demonstrated to be safe.
The study also evaluates the performance and safety of the "MD Diabetes Huolijono" software application, which issues alerts to healthcare professionals if glucose control worsens or if the patient is hospitalized. Between visits, patients using a Libre sensor with multiple daily insulin injections will be monitored using the MD Diabetes Huolijono system, while other patients will continue standard self-monitoring.
Healthcare contact data will be retrieved from the data service for each participant for the 24 months prior to study enrollment and throughout the follow-up period.
Study:
NCT07128992
Study Brief:
Protocol Section:
NCT07128992