GLucose Monitoring Programme SingaporeE (GLiMPSE)

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Combination Product: Flash Glucose Monitoring and structured education

• Registration Number: NCT03837262
• Lead Sponsor: Singapore General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2019-03-25
• Primary Completion: 2020-01-23
• Study Completion: 2020-04-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Adults

1. Adults (Age > 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)
2. Singapore Citizen or Permanent Resident
3. Treatment with diet and exercise alone or other glucose-lowering therapies except prandial insulin. GLP-1 agonists and / or basal insulin (NPH insulin, Insulin Lantus, Insulin Toujeo, Insulin Detemir) are permitted.
4. Self-reported regular blood glucose testing via CBG (more than 3/week)

Children

1. Children and adolescents (Age between 12 and 21 years old) with Type 2 diabetes and HbA1c >8% at the time of enrolment
2. Singapore Citizen or Permanent Resident
3. Insulin replacement as part of diabetes management

Exclusion Criteria

1. Age above 75 years
2. Type 1 diabetes, monogenic diabetes
3. Prandial insulin (quick-acting insulin or premixed insulin)
4. Cancer requiring treatment in the past 5 years
5. Chronic renal failure (eGFR<45ml/min) or dialysis
6. Amputation of lower limbs (excluding toe amputations)
7. Bariatric surgery for weight loss
8. Current systemic treatment with steroids
9. Pregnancy, attempting pregnancy or lactation.
10. Haemolytic anaemia or haemoglobinopathy
11. Prior use of the flash glucose monitoring system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flash glucose monitoring	Flash Glucose Monitoring and structured education	Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education

Primary Outcome Measures

Name	Time	Method
Recruitment and retention	26 weeks	Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites

Secondary Outcome Measures

Name	Time	Method
Questionnaire	24 weeks	Questionnaire to assess the acceptability of wear of the flash glucose monitoring system
HbA1c	24 weeks	Measurement of HbA1c will be performed at baseline, week 12 and week 24
WPAI questionnaire	24 weeks	Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24
DSS questionnaire	24 weeks	Diabetes Distress scale to be administered at baseline and week 24
EQ-5D-5L Questionnaire	24 weeks	EQ-5D-5L Questionnaire to be administered at baseline and week 24

Trial Locations

Locations (3)

KKH; 🇸🇬 Singapore, Singapore

Pasir Ris Polyclinic; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore