The effect of telemedicine and cognitive behavioural therapy on sleep and health outcomes in type 2 diabetes patients: a randomized controlled trial

Not Applicable

• Conditions: type 2 diabetes; insomnia; Metabolic and Endocrine - Diabetes; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12623000488606
• Lead Sponsor: School of Medicine and Dentistry, Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-12
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

(1) Patients meet the diagnostic criteria for both type 2 diabetes and insomnia, and type 2 diabetes is the primary cause of insomnia
(2) Patients aged over 18
(3) Patients not currently participating in similar intervention programs
(4) Patients fully understand the program contents, willing to participate and signed the informed consent form
(5) Patients able to use smart phones or computers to receive and view intervention materials

Diagnostic criteria for type 2 diabetes:
(1) Fasting plasma glucose greater than or equal to 7.0 mmol/l (fasting time >8 hours)
(2) Two-hour postprandial blood glucose greater than or equal to 11.1mmol/l
(3) Random plasma glucose greater than or equal to 11.1 mmol/L in patients with classic symptoms of hyperglycemia or hyperglycemic crisis
(4) Glycated Hemoglobin (HbA1c) greater than or equal to 6.5%

Screening for insomnia: Insomnia Severity Index score greater than 10

To determined if type 2 diabetes is the primary cause of insomnia:
(1) Insomnia symptoms occurs or worsens after the diagnosis of type 2 diabetes.
(2) Patients have worries about type 2 diabetes

Exclusion Criteria

(1) Patients with severe primary diseases, including severe heart, liver or renal system diseases and cancer
(2) Patients with severe psychiatric diseases that affect regular cognition and communication, including severe depression (HAMD score>18), anxiety (HAMA score>14) and schizophrenia
(3) Patients diagnosed with sleep disorders other than insomnia, including obstructive sleep apnoea, restless leg syndrome, parasomnia and hypersomnia through self-report or PSG devices.
(4) Patients who are pregnant
(5) Patients who are illiterate and cannot understand the intervention contents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified