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NCT07916584
A Nurse-Led Digital Coaching Program to Improve Blood Sugar Control in Adults With Type 2 Diabetes
Conditions: Type 2 Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Alexandria University
Location: Primary Health Care Centres, Ministry of Health Manama
Summary
The goal of this clinical trial is to learn whether ChronoCoach, a nurse-led multidisciplinary digital coaching program, improves blood sugar control and self-management in adults with type 2 diabetes attending primary health care diabetes services in Bahrain. The main question it aims to answer is: Does ChronoCoach plus usual care lower HbA1c more than usual care alone after 3 months? Researchers will also compare diabetes self-care, self-efficacy, family involvement, quality of life and satisfaction, and will explore feasibility and acceptability.
Participants will be randomly assigned to ChronoCoach or usual care. ChronoCoach participants will use a smartphone app for 3 months to record blood glucose, medicines, symptoms, food and activity, and will receive structured coaching from a diabetes nurse with pharmacy, nutrition, exercise, psychological and physician input when needed. All participants continue usual care and complete HbA1c testing and questionnaires at baseline, 3 months and 6 months.
Research hypothesis:
\* Participants allocated to ChronoCoach will have a greater reduction in HbA1c than participants receiving usual care, after adjusting for baseline HbA1c.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older
* Clinical diagnosis of type 2 diabetes mellitus for at least 1 year
* Most recent HbA1c of 7.0% or higher within the previous 3 months
* Receiving outpatient diabetes care at a participating primary health care centre
* Owns or has regular access to a compatible smartphone and is able to use the ChronoCoach app, independently or with support from a family member
* Able to communicate in Arabic or English
* Able to provide written informed consent and attend follow-up at 3 and 6 months
Exclusion Criteria:
* Acute or unstable clinical condition requiring urgent or inpatient management at recruitment
* Clinical, cognitive or psychiatric impairment preventing informed consent or safe participation in the digital intervention
* Unable to use the digital platform despite reasonable training and support
* Current participation in another intervention study likely to influence glycemic control or diabetes self-management
* Participation in the ChronoCoach pilot (usability) phase
* Pregnancy or planning pregnancy during the study period
Source: ClinicalTrials.gov (NCT07916584). StuddyBuddy aggregates publicly available trial information.