Diabetes Mellitus, Type 2
Conditions
Keywords
Flash Glucose Monitoring
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.
Interventions
COMBINATION_PRODUCTFlash 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
Sponsors
KK Women's and Children's Hospital
SingHealth Polyclinics
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| WPAI questionnaire | 24 weeks | Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24 |
Countries
Singapore
Outcome results
None listed