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

INTERVENTION: Cognitive behavioural therapy intervention targeting both type 2 diabetes and insomnia delivered by a therapist who have received full training for cognitive behavioural therapy intervention delivery. The intervention contains 10 online sessions delivered weekly in groups of 10 to 12. The approximate duration of each session is 60 minutes. Participants receive online reading materials before each session. The online reading materials are designed specifically for this study and participants are recommended (not compulsory) to read the materials prior to the session. Contents included in the intervention are knowledges and skills on sleep restriction, stimulus control, sleep hygiene, cognitive restructure, relaxation training, self‐monitoring of blood glucose, diet, exercise and substance intake management. The skills participants are prescribed in the cognitive behavioural therapy include: (1) keep a sleep diary for self‐monitoring of sleep quality; (2) develop and keep a regulated sleep schedule; (3) identify and avoid the behaviours that are not beneficial for sleep and blood glucose control; (4) identify and change the understandings and thoughts that are not beneficial for sleep and blood glucose control; (5) set up bedroom environment that promote sleep; (6) physical and mental relaxation skills; (7) skills for self‐monitoring of blood glucose; (8) develop a balanced diet; (9) develop a healthy exercise plan; (10) communication skills to share own difficulties and feelings to others. Practice of these skills are part of the weekly sessions leaded by the therapist. Patients are also required to practice these skills after the weekly sessions and share their progress in the following sessions. Strategies used to monitor and ensure the adherenc CONDITION: Mental Health ‐ Other mental health disorders Metabolic and Endocrine ‐ Diabetes Neurological ‐ Other neurological disorders type 2 diabetes;insomnia; ; type 2 diabetes ; insomnia PRIMARY OUTCOME: Insomnia severity measured by total score of Insomnia Severity Index[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Overall sleep quality measured by total score of Pittsburgh Sleep Quality Index[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Total sleep time (minutes) from self‐recorded sleep diaries and polysomnography devices (if applicable)[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] SECONDARY OUTCOME: Anxiety measured by the total score of Hamilton Anxiety Rating Scale[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Blood urea nitrogen (mmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Body Mass Inde X(BMI) calculated through weight measured by weight scale and height measured by stadiometer[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Depression measured by total score of Hamilton Depression Rating Scale[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Diastolic blood pressure (DBP, mmhg) assessed by manual sphygmomanometer[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Fasting blood glucose (mmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention , 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Fatigue level measured by total score of Multidimensional Fatigue Inventory[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Glycated Hemoglobin (HbA1c, %) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] High density lipoprotein cholesterol (mmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Hip circumference measured by tape measure[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Low density lipoprotein cholesterol (mmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Number of awakenings from self‐recorded sleep diaries and polysomnography devices (if applicable) ; ; This is also a primary outcome.[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Quality of life measured by total score of 12‐question short‐form survey[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Self‐rated sleep quality (1‐5 points) from self‐recorded sleep diaries ; ; This is also a primary outcome.[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Serum creatinine (µmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Sleep efficiency (%) from self‐recorded sleep diaries and polysomnography devices (if applicable) ; ; This is also a primary outcome[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Sleep onset latency (mins) from self‐recorded sleep diaries and polysomnography devices (if applicable) ; ; This is also a primary outcome[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Systolic blood pressure (SBP, mmhg) assessed by manual sphygmomanometer[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Total cholesterol (mmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Total time in bed (mins) from self‐recorded sleep diaries and polysomnography devices (if applicable) ; ; This is also a primary outcome.[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Triglyceride (mmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Uric acid (µmol/l) from blood samples[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Waist circumference measured by tape measure[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Waist‐hip ratio calculated through waist circumference measured by tape measure and hip circumference measured by tape measure[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Wake after sleep onset (mins) from self‐recorded sleep diaries and polysomnography devices (if applicable) ; ; This is also a primary outcome.[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention (primary endpoint), 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] Weight (kg) measured by weight scale[Baseline (before the beginning of the intervention), 3 months after the beginning of the intervention, 6 month after the beginning of the intervention (follow‐up, secondary endpoint)] 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 Inde Xscore greater than 10 To dete