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Not yet recruiting NCT06586879

Psychiatric Comorbidities in Type 1 Diabetes Mellitus.

Observational Type 1 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 8 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Psychiatric Comorbidities in Children and Adolescent Patients with Diabetes Mellitus Type 1.

Overview

This study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1. Assessing the impact of diabetes mellitus type 1 on quality of life. And determine the effect of associated factors on the development of psychiatric comorbidities and on quality of life in diabetes mellitus type 1.

Detailed description

Type 1 diabetes mellitus (TDM) is a chronic autoimmune disease. that affected carbohydrate metabolism and caused by insulin insufficiency resulting in increased blood glucose. It's one of the most common endocrine and metabolic conditions in childhood. There's 9 million people live with T1DM worldwide according to International Diabetes Federation. In Egypt, 1 in 98 families are impacted and the disease is growing at 6.7% each year. Living with T1DM has been associated with a significant impact on a person's social, mental, and psychological quality of life (QoL). as the individual must adopt blood glucose monitoring, use of injections or diabetes technology for insulin regulation, diet restrictions, and exercise. Also, there's increased risk of developing micro-and macro-vascular complications that result in morbidity and mortality in Long-term uncontrolled DM. therefore, these children and adolescents with T1DM have an increased risk of psychiatric comorbidities like depression, anxiety and sleep disorders, depression is one of the most common disorders. They appear to have a greater incidence of depression, anxiety and poor health-related quality of life (HRQoL) compared to their healthy peers. This is associated with suboptimal diabetes outcomes and better metabolic control has been found to correlate with better quality of life. This occurs especially when diagnosed at earlier age of onset, history of severe hypoglycemia and chronic hyperglycemia. There are no available studies that assess the presence of psychiatric comorbidities in T1DM in our locality.

Primary outcome measures

  • The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1. [Time frame: 2 years]
  • the prevalence of depression, anxiety and sleep disorder in children and adolescents with diabetes mellitus type 1 [Time frame: 2 years]
Secondary outcome measures (1)
  • The impact of diabetes mellitus type 1 on quality of life. [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Children and adolescents aged between 8 and 15 years, diagnosed with diabetes mellitus type 1 and on medical treatment.

Exclusion criteria

  • Patients with major psychiatric disorders or have cognitive difficulties.
  • Patients unable or refuse to give consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Ashraf MN, Cheng AYY, Robinson DJ. Emotional, Psychological, and Social Well-being Experience of Long-Term Living with Type 1 Diabetes Mellitus: A Patient-Psychiatrist-Endocrinologist Perspective. Diabetes Ther. 2024 Feb;15(2):317-323. doi: 10.1007/s13300-023-01527-w. Epub 2024 Jan 17. PMID 38233629
  • Abouzid MR, Ali K, Elkhawas I, Elshafei SM. An Overview of Diabetes Mellitus in Egypt and the Significance of Integrating Preventive Cardiology in Diabetes Management. Cureus. 2022 Jul 20;14(7):e27066. doi: 10.7759/cureus.27066. eCollection 2022 Jul. PMID 36000101
  • El-Ziny MA, Salem NA, El-Hawary AK, Chalaby NM, Elsharkawy AA. Epidemiology of childhood type 1 diabetes mellitus in Nile Delta, northern Egypt - a retrospective study. J Clin Res Pediatr Endocrinol. 2014;6(1):9-15. doi: 10.4274/Jcrpe.1171. PMID 24637304

Identifiers

NCT: NCT06586879 · Psychiatry in type 1 DM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗