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Type 2 Diabetes MellitusChronoCoachNCT07916584

A Nurse-Led Digital Coaching Program to Improve Blood Sugar Control in Adults With Type 2 Diabetes

A study testing ChronoCoach and Usual diabetes care in people with Type 2 Diabetes Mellitus, run by Alexandria University at 1 site in Bahrain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
ChronoCoach and Usual diabetes care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteBahrain
Study dates
Nov 2026to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zohour I Rashwan contact

+973 35094573

zohour.rashwan@alexu.edu.eg

Bahrain1 site

  • Primary Health Care Centres, Ministry of Health

    Manama

    Toqa Busebaia, +973 36000883, tjameel@uob.edu.bh

Other trials in Bahrain

About this study

Official title: ChronoCoach: A Nurse-Led Multidisciplinary Digital Intervention to Improve Glycemic Control and Self-Management Among Adults With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

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.

Read more

Research hypothesis:

  • Participants allocated to ChronoCoach will have a greater reduction in HbA1c than participants receiving usual care, after adjusting for baseline HbA1c.
Read the detailed description

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.

Being tested
ChronoCoach, Usual diabetes care
Keywords
Diabetes self-management, Nurse-led care, Mobile health (mHealth), Digital health, Health coaching, Glycated hemoglobin (HbA1c), Self-efficacy, Family involvement, Multidisciplinary care, Bahrain
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChronoCoachBehavioural

    Also called ChronoCoach nurse-led digital diabetes self-management program

    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.

  • Usual diabetes careOther

    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.

Study groups in NCT07916584
Study groupRoleWhat they receive
ChronoCoach GroupExperimentalChronoCoach nurse-led multidisciplinary digital self-management program for 3 months, in addition to usual diabetes care.
Receives: Behavioral: ChronoCoach
Usual Care GroupActive comparatorUsual diabetes care at the participating primary health care centre.
Receives: Other: Usual diabetes care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 3 months

Secondary outcomes (5)

  1. 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.

    Measured: Baseline, 3 months and 6 months

  2. 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.

    Measured: Baseline, 3 months and 6 months

  3. 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.

    Measured: Baseline, 3 months and 6 months

  4. 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.

    Measured: Baseline, 3 months and 6 months

  5. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm, 1:1 individually randomized controlled trial comparing ChronoCoach plus usual care with usual care alone, with an embedded qualitative process evaluation in a purposive subsample.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07916584
Sponsor's protocol ID
1223568698
Acronym
ChronoCoach
Status last verified
Nov 2026
First submitted
9 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • American Diabetes Association Professional Practice Committee for Diabetes*. 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Supplement_1):S89-S131. doi: 10.2337/dc26-S005.

    PubMed 41358898

  • Powers MA, Bardsley JK, Cypress M, Funnell MM, Harms D, Hess-Fischl A, Hooks B, Isaacs D, Mandel ED, Maryniuk MD, Norton A, Rinker J, Siminerio LM, Uelmen S. Diabetes Self-management Education and Support in Adults With Type 2 Diabetes: A Consensus Report of the American Diabetes Association, the Association of Diabetes Care & Education Specialists, the Academy of Nutrition and Dietetics, the American Academy of Family Physicians, the American Academy of PAs, the American Association of Nurse Practitioners, and the American Pharmacists Association. Diabetes Care. 2020 Jul;43(7):1636-1649. doi: 10.2337/dci20-0023. Epub 2020 Jun 8. No abstract available.

    PubMed 32513817

  • Sun J, Fan Z, Kou M, Wang X, Yue Z, Zhang M. Impact of nurse-led self-management education on type 2 diabetes: a meta-analysis. Front Public Health. 2025 Aug 11;13:1622988. doi: 10.3389/fpubh.2025.1622988. eCollection 2025.

    PubMed 40860544

  • Kerr D, Ahn D, Waki K, Wang J, Breznen B, Klonoff DC. Digital Interventions for Self-Management of Type 2 Diabetes Mellitus: Systematic Literature Review and Meta-Analysis. J Med Internet Res. 2024 Jul 22;26:e55757. doi: 10.2196/55757.

    PubMed 39037772

  • Hou C, Xu Q, Diao S, Hewitt J, Li J, Carter B. Mobile phone applications and self-management of diabetes: A systematic review with meta-analysis, meta-regression of 21 randomized trials and GRADE. Diabetes Obes Metab. 2018 Aug;20(8):2009-2013. doi: 10.1111/dom.13307. Epub 2018 May 3.

    PubMed 29582538

  • Tang Z, Zhao L, Li J, Yang Y, Liu F, Li H, Yang Z, Qin S, Li X. Prognostic effectiveness of interactive vs. non-interactive mobile app interventions in type 2 diabetes: a systematic review and meta-analysis. Arch Public Health. 2024 Nov 22;82(1):221. doi: 10.1186/s13690-024-01450-x.

    PubMed 39578910

  • Ryan P, Sawin KJ. The Individual and Family Self-Management Theory: background and perspectives on context, process, and outcomes. Nurs Outlook. 2009 Jul-Aug;57(4):217-225.e6. doi: 10.1016/j.outlook.2008.10.004.

    PubMed 19631064

Questions about this trial

What is this clinical trial studying?

A study testing ChronoCoach and Usual diabetes care in people with Type 2 Diabetes Mellitus, run by Alexandria University at 1 site in Bahrain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zohour I Rashwan (+973 35094573, zohour.rashwan@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated hemoglobin (HbA1c) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07916584, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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