GLucose Monitoring Programme SingaporeE (GLiMPSE)

Diabetes Mellitus, Type 2 Clinical Trial

— GLiMPSE  

Official title:

GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837262
• Other study ID #: GLiMPSE-POC1
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2020
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 30, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Singapore	KKH	Singapore
Singapore	Pasir Ris Polyclinic	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Singapore General Hospital	KK Women's and Children's Hospital, SingHealth Polyclinics

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment and retention	Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites	26 weeks
Secondary	Questionnaire	Questionnaire to assess the acceptability of wear of the flash glucose monitoring system	24 weeks
Secondary	HbA1c	Measurement of HbA1c will be performed at baseline, week 12 and week 24	24 weeks
Secondary	DSS questionnaire	Diabetes Distress scale to be administered at baseline and week 24	24 weeks
Secondary	EQ-5D-5L Questionnaire	EQ-5D-5L Questionnaire to be administered at baseline and week 24	24 weeks
Secondary	WPAI questionnaire	Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24	24 weeks