GLucose Monitoring Programme SingaporeE (GLiMPSE) (GLiMPSE)

GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Combination product: Flash Glucose Monitoring and structured education

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KKH
  • Singapore, Singapore, 169856
    • Singapore General Hospital
  • Singapore, Singapore, 519457
    • Pasir Ris Polyclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Flash glucose monitoring; Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: KK Women's and Children's Hospital; SingHealth Polyclinics
• Investigators: Principal Investigator: Daphne SL Gardner, MD, Singapore General Hospital, SingHealth

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2019
• Primary Completion (ACTUAL): January 23, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (ACTUAL): February 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 6, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Flash Glucose Monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GLiMPSE-POC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No