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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05477433
Other study ID # diabetes mellitus
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date December 1, 2025

Study information

Verified date July 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The most common endocrine illness in children and adolescents is type 1 diabetes. It is distinguished by a lack of insulin synthesis and necessitates daily insulin injections to keep glucose levels under control. As a result, there are numerous medical approaches to its management, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycemic control during the previous three months and monitoring of blood glucose levels, which affect the patient's mental health and quality of life. Type 1 diabetes complications and poor quality of life are widespread. Diabetes therapy is difficult during puberty and adolescence. Adolescents with T1D have poor metabolic control and a higher rate of acute complications. Because the onset of adolescence is frequently associated with decreased adherence to therapy and an increased risk of psychological illnesses.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date December 1, 2025
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years to 19 Years
Eligibility Inclusion Criteria: 1. Both males and females were included. 2. Age ranges from 10 to 19 years. 3. Willing of the parents or the caregivers to participate in the study. 4. Duration of T1DM of at least 1 year. Exclusion Criteria 1. Adolescents with an intelligence quotient below 70. 2. Adolescents with a history of substance use or psychiatric disorders. 3. Adolescents with medical or other neurological conditions.

Study Design


Intervention

Behavioral:
diabetes mellitus type 1
Pittsburgh Sleep Quality Index "PSQI": It is used to detect sleep disturbance or deficits. The PSQI has a scoring key that can be used to calculate a patient's seven subscores, which range from 0 to 3. The subscores are added together to produce a "global" score that ranges from 0 to 21. A global score of 5 or higher denotes poor sleep quality, The Strengths and Dif?culties Questionnaire (SDQ) The SDQ is a well-validated screening tool for children and adolescents aged 4-17 years that can identify behavioural and emotional issues,Emotional Avoidance Strategy Inventory for Adolescents (EASI) is used. The EASI-A is a 17-item assessing the use of emotionally avoidant strategies in adolescents and higher scores means significants use avoidant strategies, The Toronto Alexithymia Scale (TAS-20) is a self-administered 20-item questionnaire which assesses difficulties in identifying and describing emotions. TAS scores were significantly higher in alexithymia

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Measure frequency of sleep problems with diabetes mellitus type 1 through study completion, an average of 1 year
Primary Measures frequency of psychiatric problems with diabetes mellitus type 1 through study completion, an average of 1 year
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