NCT03837262

GLucose Monitoring Programme SingaporeE (GLiMPSE)

GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to evaluate the feasibility and acceptability of the flash glucose monitoring system together with a structured education programme in individuals with Type 2 Diabetes.

Detailed description

Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore. For Adults, this phase consists of screening and intervention periods. Screening Period (Week -2 to -1): Participants will be asked to wear a blinded flash glucose monitoring system and will be asked to continue testing their capillary glucose readings at least once daily for 2 weeks (week -2 to week -1). Sensor glucose measurements are not available to both participants and investigators during this screening period. Participants who are able to wear the sensor for the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for the 2 weeks (\>10 readings/2weeks), will proceed on with the intervention period. Intervention Period (Week 0 - 26): Participants will wear a personal version of the flash glucose monitoring system continuously for the next 6 weeks. After these 6 weeks, they will wear the sensor intermittently (one sensor lasting 2 weeks, per 4 weeks) for the following 18 weeks.Participants in this arm will receive an education package that consists of Diabetes nurse educator and/or dietitian appointments during weeks 0, 2, 6 and 24. After week 24, they will put on a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). HbA1c will be monitored at weeks 0, 14 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user. Paediatric participants will not undergo blinded sensor wear but will undergo the intervention period, with the schedule of wear identical to the adults'. The education curriculum will be age-appropriate and will be delivered over weeks 0, 2, 6, 12, and 24. Their HbA1c will be monitored at week 0, 12 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Flash Glucose Monitoring and structured education	A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children

Timeline

• Start date: 2019-03-25
• Primary completion: 2020-01-23
• Completion: 2020-04-30
• First posted: 2019-02-12
• Last updated: 2020-09-09

Locations

3 sites across 1 country: Singapore