NCT03837262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

February 7, 2019

Last Update Submit

September 6, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

Flash Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Questionnaire

    24 weeks

  • HbA1c

    24 weeks

  • DSS questionnaire

    24 weeks

  • EQ-5D-5L Questionnaire

    24 weeks

  • WPAI questionnaire

    24 weeks

Study Arms (1)

Flash glucose monitoring

EXPERIMENTAL

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

Interventions

Flash Glucose Monitoring and structured educationCOMBINATION_PRODUCT

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

Flash glucose monitoring

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Singapore General Hospital

Singapore, 169856, Singapore

Location

KKH

Singapore, 229899, Singapore

Location

Pasir Ris Polyclinic

Singapore, 519457, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Daphne SL Gardner, MD

    Singapore General Hospital, SingHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 12, 2019

Study Start

March 25, 2019

Primary Completion

January 23, 2020

Study Completion

April 30, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

SG(3)