Clinical trial NCT03837262: GLucose Monitoring Programme SingaporeE (GLiMPSE)
Official title: GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Flash Glucose Monitoring
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: KK Women's and Children's Hospital
name: SingHealth Polyclinics
First posted: 2019-02-12
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and retention
timeFrame: 26 weeks
Secondary outcomes:
measure: Questionnaire
timeFrame: 24 weeks
measure: HbA1c
timeFrame: 24 weeks
measure: DSS questionnaire
timeFrame: 24 weeks
measure: EQ-5D-5L Questionnaire
timeFrame: 24 weeks
measure: WPAI questionnaire
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: KKH
city: Singapore
country: Singapore
facility: Pasir Ris Polyclinic
Study officials:
affiliation: Singapore General Hospital, SingHealth
name: Daphne SL Gardner, MD
role: PRINCIPAL_INVESTIGATOR
References: