GLucose Monitoring Programme SingaporeE (GLiMPSE) (GLiMPSE)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Flash Glucose Monitoring and structured education
Sponsored by

About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Flash Glucose Monitoring
Eligibility Criteria
Inclusion Criteria:
Adults
- Adults (Age > 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)
- Singapore Citizen or Permanent Resident
- 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.
- Self-reported regular blood glucose testing via CBG (more than 3/week)
Children
- Children and adolescents (Age between 12 and 21 years old) with Type 2 diabetes and HbA1c >8% at the time of enrolment
- Singapore Citizen or Permanent Resident
- Insulin replacement as part of diabetes management
Exclusion Criteria:
- Age above 75 years
- Type 1 diabetes, monogenic diabetes
- Prandial insulin (quick-acting insulin or premixed insulin)
- Cancer requiring treatment in the past 5 years
- Chronic renal failure (eGFR<45ml/min) or dialysis
- Amputation of lower limbs (excluding toe amputations)
- Bariatric surgery for weight loss
- Current systemic treatment with steroids
- Pregnancy, attempting pregnancy or lactation.
- Haemolytic anaemia or haemoglobinopathy
- Prior use of the flash glucose monitoring system
Sites / Locations
- Singapore General Hospital
- KKH
- Pasir Ris Polyclinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flash glucose monitoring
Arm Description
Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education
Outcomes
Primary Outcome Measures
Recruitment and retention
Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites
Secondary Outcome Measures
Questionnaire
Questionnaire to assess the acceptability of wear of the flash glucose monitoring system
HbA1c
Measurement of HbA1c will be performed at baseline, week 12 and week 24
DSS questionnaire
Diabetes Distress scale to be administered at baseline and week 24
EQ-5D-5L Questionnaire
EQ-5D-5L Questionnaire to be administered at baseline and week 24
WPAI questionnaire
Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24
Full Information
NCT ID
NCT03837262
First Posted
February 7, 2019
Last Updated
September 6, 2020
Sponsor
Singapore General Hospital
Collaborators
KK Women's and Children's Hospital, SingHealth Polyclinics
1. Study Identification
Unique Protocol Identification Number
NCT03837262
Brief Title
GLucose Monitoring Programme SingaporeE (GLiMPSE)
Acronym
GLiMPSE
Official Title
GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
KK Women's and Children's Hospital, SingHealth Polyclinics
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Flash Glucose Monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flash glucose monitoring
Arm Type
Experimental
Arm Description
Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education
Intervention Type
Combination Product
Intervention Name(s)
Flash Glucose Monitoring and structured education
Intervention Description
A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children
Primary Outcome Measure Information:
Title
Recruitment and retention
Description
Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Questionnaire
Description
Questionnaire to assess the acceptability of wear of the flash glucose monitoring system
Time Frame
24 weeks
Title
HbA1c
Description
Measurement of HbA1c will be performed at baseline, week 12 and week 24
Time Frame
24 weeks
Title
DSS questionnaire
Description
Diabetes Distress scale to be administered at baseline and week 24
Time Frame
24 weeks
Title
EQ-5D-5L Questionnaire
Description
EQ-5D-5L Questionnaire to be administered at baseline and week 24
Time Frame
24 weeks
Title
WPAI questionnaire
Description
Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults
Adults (Age > 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)
Singapore Citizen or Permanent Resident
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.
Self-reported regular blood glucose testing via CBG (more than 3/week)
Children
Children and adolescents (Age between 12 and 21 years old) with Type 2 diabetes and HbA1c >8% at the time of enrolment
Singapore Citizen or Permanent Resident
Insulin replacement as part of diabetes management
Exclusion Criteria:
Age above 75 years
Type 1 diabetes, monogenic diabetes
Prandial insulin (quick-acting insulin or premixed insulin)
Cancer requiring treatment in the past 5 years
Chronic renal failure (eGFR<45ml/min) or dialysis
Amputation of lower limbs (excluding toe amputations)
Bariatric surgery for weight loss
Current systemic treatment with steroids
Pregnancy, attempting pregnancy or lactation.
Haemolytic anaemia or haemoglobinopathy
Prior use of the flash glucose monitoring system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne SL Gardner, MD
Organizational Affiliation
Singapore General Hospital, SingHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Facility Name
KKH
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Pasir Ris Polyclinic
City
Singapore
ZIP/Postal Code
519457
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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GLucose Monitoring Programme SingaporeE (GLiMPSE)
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