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NCT07916584Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
160 (estimated)
First submitted
9 Oct 2026
Start date
Nov 2026
Primary completion date
Sept 2027
Lead sponsor
Alexandria University
NCT number
NCT07916584

What you commit to

  • Study type: Interventional
  • Planned participants: 160
  • From Nov 2026 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • Current participation in another intervention study likely to influence glycemic control or diabetes self-management

Other

  • Unable to use the digital platform despite reasonable training and support
  • Participation in the ChronoCoach pilot (usability) phase
  • Pregnancy or planning pregnancy during the study period

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Primary Health Care Centres, Ministry of Health
Coordinator of this site? Confirm its status
ManamaBahrainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.