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A randomized controlled trial to study the feasibility of smartphone application in management of blood glucose levels among patients diagnosed with Gestational Diabetes Mellitus

Smartphone App For Management Of Gestational Diabetes Mellitus In Urban And Rural Settings In India: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042382
Enrollment
240
Registered
2022-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Intervention1: App based management: In addition to standard care, this group will use the Mobile App. This group will be provided with the same devices as the control group and in addition, the GDM a

Sponsors

Indian Council of Medical Research New Delhi India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Women with age 18 to 40 years. 2) Diagnosis of gestational diabetes mellitus. 3) GDM diagnosed before 30 weeks of pregnancy. 4) Singleton gestation 5) Receiving antenatal care in antenatal OPD of AIIMS New Delhi and CRHSP Ballabhgarh. 6) Owns a smartphone with internet connectivity at home.

Exclusion criteria

Exclusion criteria: 1) Not willing to participate. 2) Women with type 1 and type 2 diabetes 3) Patients with learning difficulties or vision/hearing impairments 4) Women who are unable to read English/Hindi script.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the compliance rate between app-based management and conventional technique, which is also used for the sample size calculation to determine the effects of the intervention. The compliance rate will be assessed as the actual blood glucose measurements divided by instructed measurements multiplied by 100.Timepoint: The outcome will be assessed at delivery and at 6-weeks post-delivery.

Secondary

MeasureTime frame
â?¢ To test the preliminary efficacy of the app in both urban and rural settings in India. â?¢ To compare patient satisfaction in both groups (App-based care v/s standard care) in an urban and rural setting. â?¢ To assess the feasibility of App-based management GDM in both rural and urban settings. â?¢ To compare the acceptability of the app in health care workers in rural and urban settings. Timepoint: Baseline till delivery

Countries

India

Contacts

Public ContactRinchen Zangmo

Department of Obstetrics and Gynaecology, AIIMS, New Delhi

rinchhen.zn@gmail.com9910557436

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026