We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Psychiatric Disorders Related to Diabetes Mellitus Type 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05477433
Recruitment Status : Not yet recruiting
First Posted : July 28, 2022
Last Update Posted : July 28, 2022
Information provided by (Responsible Party):
Gellan Karamalllah Ramadan Ahmed, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Diabetes Mellitus Type 1 Adolescents Psychiatric Disorders Behavioral: diabetes mellitus type 1

Layout table for study information
Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Adolescents in Egypt
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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 Difficulties 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

Primary Outcome Measures :
  1. Measure frequency of sleep problems with diabetes mellitus type 1 [ Time Frame: through study completion, an average of 1 year ]
  2. Measures frequency of psychiatric problems with diabetes mellitus type 1 [ Time Frame: through study completion, an average of 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will be screening for adolescents with diabetes mellitus

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.
Layout table for additonal information
Responsible Party: Gellan Karamalllah Ramadan Ahmed, lecturer of neurology and psychiatry,faculty of medicine, Assiut University
ClinicalTrials.gov Identifier: NCT05477433    
Other Study ID Numbers: diabetes mellitus
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Mental Disorders
Problem Behavior
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Autoimmune Diseases
Immune System Diseases