Feasibility Testing of the "MyGlucoCare" Smartphone App for Women With Gestational Diabetes

NCT07372872 | Not Yet Recruiting DMC

• 1 other identifier: PFDS/2025/21
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot study is to test the feasibility and preliminary impact of "MyGlucoCare," a smartphone-based program designed to support women with gestational diabetes (GDM). The main questions it aims to answer are: Is the "MyGlucoCare" program practical and acceptable for participants? Does it show preliminary signs of improving self-management, blood sugar control, and well-being in women with gestational diabetes (GDM)? Researchers will conduct a single-arm study to gather initial data on the program's use and effects, which will be used to plan a larger future clinical trial. Participants will: Use the "MyGlucoCare" app for 8-12 weeks during their pregnancy. Receive personalized education, support from a clinician, and access to a moderated peer group through the app. Complete questionnaires and log health data via the app at the start, near the end of pregnancy, and after giving birth. Some participants will also take part in an interview to share their feedback on the program.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

GDM; Smartphone-Based Self-Management; Personalised Support

Outcome Measures

Primary Outcomes (3)

• Enagagement

  Measures participant interaction with the study protocol and app (%). • Measures: Mean/median frequency of (e.g., per week)

  8-12 weeks

• Recruitment & Retention Rates

  Assesses the practicality of executing the trial. • Unit of Measure: Proportion/Percentage (%) for each

  8-12 weeks

• System Usability

  Quantifies the perceived usability of the "MyGlucoCare" app using a validated instrument.• Measure: Mean score on the System Usability Scale (SUS). • Unit of Measure: Score on a scale (0-100).

  8-12 weeks

Secondary Outcomes (1)

• Secondary outcome measures

  All changes measured from baseline (T0) to post-intervention (T1, 8-12 weeks), except postpartum OGTT and delivery outcomes collected at T2 (postpartum period).

Study Arms (1)

"MyGlucoCare" intervention

EXPERIMENTAL

The "MyGlucoCare" intervention is a comprehensive, technology-facilitated program delivered over 8 to 12 weeks.

Device: MyGlucoCare

Interventions

MyGlucoCare DEVICE

The "MyGlucoCare" intervention is a comprehensive, technology-facilitated program delivered over 8 to 12 weeks. It integrates three core components to provide holistic and personalised support for women with gestational diabetes (GDM).

"MyGlucoCare" intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women diagnosed with gestational diabetes (GDM) via a 75g Oral Glucose Tolerance Test (OGTT), conducted between 24 and 28 weeks of gestation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women diagnosed with Gestational Diabetes Mellitus (GDM) via a 75g Oral Glucose Tolerance Test (OGTT), conducted between 24 and 28 weeks of gestation (Hong Kong College of Obstetricians and Gynaecologists, 2016).
• Aged 18 years or older.
• Own a smartphone with reliable internet access.
• Able to read and understand Chinese.

You may not qualify if:

• Pre-existing diagnosis of Type 1 or Type 2 diabetes mellitus.
• Known major fetal anomaly.
• Concurrent enrollment in any other structured GDM self-management intervention.
• Severe mental health conditions.

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead

Related Publications (8)

• Wang, Y., Lei, T., & Liu, X. (2020). Chinese System Usability Scale: Translation, Revision, Psychological Measurement. International Journal of Human-Computer Interaction, 36(10), 953-963. https://doi.org/10.1080/10447318.2019.1700644

  RESULT

• Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.

  PMID: 10895844 RESULT

• Ritter, P. L., Lorig, K., & Laurent, D. D. (2016). Characteristics of the Spanish- and English-Language Self-Efficacy to Manage Diabetes Scales. The Diabetes Educator, 42(2), 167-177. https://doi.org/10.1177/0145721716628648

  RESULT

• O'Neill, B. (2022). Sample size determination with a pilot study. PLoS ONE, 17(2 February). https://doi.org/10.1371/journal.pone.0262804

  RESULT

• Lorig, K. R., Ritter, P. L., & González, V. M. (2003). Nursing Research (Vol. 52, Issue 6). http://journals.lww.com/nursingresearchonline

  RESULT

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 RESULT

• Hong Kong College of Obstetricians and Gynaecologists. (2016). HKCOG Guidelines Guidelines for the Management of Gestational Diabetes Mellitus.

  RESULT

• Jordan, P. W., Thomas, B., McClelland, I. L., & Weerdmeester, B. (1996). Usability evaluation in industry. CRC press

  RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Bronya Luk Assistant Professor, DHSc, MN, BN

CONTACT

+852 39708758; bluk@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share