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 @ 5:02 AM
Ignite Modification Date: 2025-12-25 @ 5:02 AM
NCT ID: NCT06208618
Brief Summary: The deterioration of glycemic control in adolescents with Type 1 diabetes (T1DM) is a genuine cause for concern. Possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment, pubertal increases in insulin resistance, and insufficient transition from pediatric to adult care. In adolescents with established T1DM who transition to adult-focused care, there is observed disengagement or complete detachment from care. Improving glycemic control during adolescence is a critical stage to enhance and reduce complications associated with T1DM. Adolescents with T1DM require appropriate daily insulin therapy, regular blood sugar monitoring, physical activity, healthy nutrition, education, and support to delay or prevent diabetes-related complications.This study aims to determine the impact of education and motivational interviews conducted through tele-nursing on the management of diabetes in adolescents with Type 1 diabetes.
Detailed Description: The study will be conducted with a single-center, single-blind, parallel-group, randomized controlled design with a follow-up period of 6 months.The population of the study consists of 141 adolescents aged 13-18 diagnosed with Type 1 diabetes, who are being followed up at the Diabetes Education Unit of Evliya Çelebi Training and Research Hospital, affiliated with Kütahya Health Sciences University in the province of Kütahya, Türkiye. The sample of the study will consist of 96 adolescents, with 48 participants in each group, assuming a 1:1 randomization, based on the reference study. In their research, where motivational interviews were used for adolescents' diabetes management, the reported HbA1c levels for the study group (9.61±2.40) and the control group with routine follow-up (10.76±2.07) at the 6-month follow-up were considered, aiming for an 80% power and a 0.05 margin of error.
Study: NCT06208618
Study Brief:
Protocol Section: NCT06208618