GLucose Monitoring Programme SingaporeE (GLiMPSE)

NCT ID: NCT03837262

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2020-04-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Flash glucose monitoring

Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education

Group Type: EXPERIMENTAL

Flash Glucose Monitoring and structured education

Intervention Type: COMBINATION_PRODUCT

A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children

Interventions

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

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

SingHealth Polyclinics

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daphne SL Gardner, MD

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital, SingHealth

Locations

Singapore General Hospital

Singapore, , Singapore

KKH

Singapore, , Singapore

Pasir Ris Polyclinic

Singapore, , Singapore

Countries

Singapore

Other Identifiers

GLiMPSE-POC1

Identifier Type: -

Identifier Source: org_study_id