A randomized controlled trial to study the feasibility of smartphone application in management of blood glucose levels among patients diagnosed with Gestational Diabetes Mellitus
Not Applicable
- Conditions
- Health Condition 1: O244- Gestational diabetes mellitus
- Registration Number
- CTRI/2022/05/042382
- Lead Sponsor
- Indian Council of Medical Research New Delhi India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢ To test the preliminary efficacy of the app in both urban and rural settings in India. <br/ ><br>â?¢ To compare patient satisfaction in both groups (App-based care v/s standard care) in an urban and rural setting. <br/ ><br>â?¢ To assess the feasibility of App-based management GDM in both rural and urban settings. <br/ ><br>â?¢ To compare the acceptability of the app in health care workers in rural and urban settings. <br/ ><br>Timepoint: Baseline till delivery