An interventional study of ChronoCoach and Usual diabetes care in Type 2 Diabetes Mellitus, sponsored by Alexandria University. Not yet recruiting at 1 site in Bahrain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care
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.
Type 2 diabetes mellitus (T2DM) requires lifelong daily self-management. Bahrain has a high diabetes burden, with adult prevalence estimated at about 22% by the International Diabetes Federation. Diabetes self-management education and support (DSMES) is an essential part of care, and nurse-led DSMES and digital interventions combined with active professional coaching have both been shown to improve HbA1c. ChronoCoach combines these approaches and places nurses at the centre of coordination, guided by the Individual and Family Self-Management Theory (Ryan \& Sawin, 2009).
Design: a two-arm, parallel-group randomized controlled trial with an embedded qualitative process evaluation (mixed methods). The trial is the evaluation phase of a four-phase program; the earlier needs assessment, platform development and usability pilot are completed before enrolment.
Randomization: after informed consent and baseline assessment, participants are allocated 1:1 using a computer-generated sequence prepared by an independent statistician, with allocation concealed until assignment.
Intervention: for 3 months the intervention group receives app training and access, self-monitoring of blood glucose with an approved commercial glucometer, reminders, symptom and medication-adherence reporting, nutrition and activity recording, glucose trend displays, and structured nurse coaching on diabetes education, goal setting and behaviour change. Nurses review data through a secure dashboard. Multidisciplinary input is provided as needed. A family member may be involved with the participant's agreement. The app does not diagnose, prescribe or change medication. Clinically concerning readings or symptoms follow a predefined escalation pathway to the treating physician. Both groups continue usual care; no treatment is withheld.
Sample size: 64 participants per group give 80% power at two-sided alpha 0.05 to detect a standardized between-group difference of 0.50 in HbA1c (for example 0.5%, assuming SD 1.0%). Allowing 20% attrition, 160 participants (80 per group) will be enrolled.
Analysis: 3-month HbA1c is compared between groups by ANCOVA adjusted for baseline HbA1c on an intention-to-treat basis, with mean differences and 95% confidence intervals. Secondary outcomes are analysed with baseline-adjusted or linear mixed models across baseline, 3 and 6 months. Interviews and focus groups are analysed thematically (Braun \& Clarke) and integrated with the quantitative findings.
9,608 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,336 are open to participants now.
This study's planned enrollment of 160 is above the median of 81 across 7,729 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Alexandria University is the lead sponsor of 596 studies on the registry; 134 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ChronoCoach nurse-led multidisciplinary digital self-management program for 3 months, in addition to usual diabetes care.
Behavioral: ChronoCoach
Usual diabetes care at the participating primary health care centre.
Other: Usual diabetes care
A nurse-led multidisciplinary digital diabetes self-management program delivered over 3 months. Participants receive training and access to a smartphone app for self-monitoring of blood glucose entry, symptom and medication-adherence reporting, nutrition and activity recording, reminders and visualization of glucose trends. Diabetes nurses review participant data on a secure dashboard and provide structured coaching on diabetes education, goal setting and behaviour change. Medication-use support, dietary counselling, physical-activity planning, psychological support and physician review are provided when needed. A family member may be involved with the participant's agreement. Concerning readings or symptoms are escalated to the treating physician through a predefined pathway; the app does not diagnose, prescribe or change medication.
Also known as: ChronoCoach nurse-led digital diabetes self-management program
Participants continue the routine diabetes care provided by their health centre, including clinically indicated medication, HbA1c monitoring, education and referral. They complete the same study assessments at baseline, 3 and 6 months.
Glycated hemoglobin (HbA1c)
HbA1c (%) measured by an accredited clinical laboratory. The between-group difference in 3-month HbA1c, adjusted for baseline HbA1c. Lower values indicate better glycemic control.
Time frame: Baseline and 3 months
Diabetes self-care behaviours - Summary of Diabetes Self-Care Activities (SDSCA)
The validated Arabic version of the Summary of Diabetes Self-Care Activities measures how many days in the past 7 days the participant carried out self-care activities. Results are reported separately for five subscales: diet, exercise, blood glucose testing, foot care, and medication taking. Each subscale score is the mean number of days per week across its items, with a minimum of 0 and a maximum of 7. Higher scores mean better self-care.
Time frame: Baseline, 3 months and 6 months
Diabetes self-efficacy - Diabetes Management Self-Efficacy Scale (DMSES)
The validated Arabic version of the 20-item Diabetes Management Self-Efficacy Scale measures how confident the participant feels about carrying out diabetes self-management tasks. Each item is rated from 0 ("cannot do at all") to 10 ("certainly can do"). The total score ranges from 0 to 200. Higher scores mean greater self-efficacy, which is a better outcome.
Time frame: Baseline, 3 months and 6 months
Health-related quality of life - WHOQOL-BREF
The validated Arabic version of the 26-item World Health Organization Quality of Life - Brief Version asks about the participant's quality of life over the past 2 weeks. Each item is rated on a 5-point scale from 1 to 5. The instrument gives four domain scores: physical health (7 items) psychological (6 items) social relationships (3 items) environment (8 items) Each domain score is converted to a 0-100 scale using the standard WHO scoring method, so the minimum is 0 and the maximum is 100. Higher scores mean better quality of life. Two further single items, on overall quality of life and general health, are scored separately from 1 to 5, where higher scores are better. Results are reported for each domain separately, not as a total score.
Time frame: Baseline, 3 months and 6 months
Family involvement in diabetes self-management - Family/Friend Involvement in Adults' Diabetes (FIAD)
The Arabic version (translated and back-translated) of the Family/Friend Involvement in Adults' Diabetes scale measures how family members and friends were involved in the participant's diabetes self-care over the past 30 days. It has two subscales: Helpful involvement (9 items): higher scores mean more helpful involvement, which is a better outcome. Harmful involvement (7 items): higher scores mean more harmful involvement, which is a worse outcome. Each item is rated from 1 to 5, and each subscale score is the mean of its items, giving a minimum of 1 and a maximum of 5. The two subscales are reported separately, not combined into a total. In this sample, Cronbach's alpha was 0.87 for the helpful subscale and 0.72 for the harmful subscale.
Time frame: Baseline, 3 months and 6 months
Participant satisfaction - Client Satisfaction Questionnaire (CSQ-8)
The 8-item Client Satisfaction Questionnaire measures satisfaction with the ChronoCoach program. Each item is rated from 1 to 4, and the items are summed for a total score with a minimum of 8 and a maximum of 32. Higher scores mean greater satisfaction, which is a better outcome.
Time frame: 3 months
Plan to share: No — Individual participant data are held under the conditions of the ethics approvals; de-identified summary data may be shared on reasonable request to the principal investigator.
Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.
Of 1,934 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 10 months is below that.
Counting every sponsor, half of 2,111 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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