GLucose Monitoring Programme SingaporE, Phase 2 (GLiMPSE2)

NCT04564911 | Unknown DMC

• 1 other identifier: GLiMPSE2
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 3

Brief Summary

Many with type 2 diabetes (T2D) remain sub-optimally controlled. Structured programmes requiring dietary and lifestyle intervention have been shown to improve control but are time-and labour-intensive. The role for self-monitoring of blood glucose with capillary blood glucose (CBG) readings is uncertain. The use of flash glucose monitoring (FGM) with education may effect improvements in awareness and self-management behaviour and hence glycaemic control. The investigators aim to compare the effects of FGM versus CBG fingersticks in the context of a structured education programme over a 6-month period in adults with type 2 diabetes. 200 adults (\>21y) with sub-optimally controlled T2D (7.5-10%) on either diet-controlled, oral glucose lowering drugs or background insulin will be enrolled and randomised into the intervention arm (FGM and education) or control arm (capillary glucose fingersticks and education). The intervention arm will monitor glucose using FGM continuously for 6 weeks and intermittently thereafter up to 24 weeks. The control group will monitor glucose using CBG fingersticks up to 24 weeks. During the intervention period(0-24w), both arms will undergo the same schedule of visits (-2w, 0w, 8w, 16w, 24w) and 6 education sessions. Both groups will be followed up at weeks 38 and 52. Primary outcome is HbA1c change from baseline at 24 weeks. This study will provide novel data on the use of FGM versus CBG in Type 2 diabetes and its impact on glycaemic control.

Conditions

Diabetes Mellitus, Type 2; Flash Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Change from baseline HbA1c at week 24

  Measurement of HbA1c will be performed at weeks 0 and 24

  24 weeks

Secondary Outcomes (11)

• Change from baseline Time in Range at week 26

  26 weeks

• Change in Baseline % Time Below Range at week 26

  26 weeks

• Change from baseline % CV glucose at week 26

  26 weeks

• Change in Weight from baseline at week 24

  24 weeks

• Change in Body Mass Index from baseline at week 24

  24 weeks

Study Arms (2)

Flash Glucose Monitoring and Education

EXPERIMENTAL

Participants randomised to the experimental arm will receive an education package and wear the flash glucose monitoring system. They will use sensor glucose data for self-management.

Combination Product: Flash Glucose Monitoring and Education

Capillary Glucose Monitoring and Education

ACTIVE COMPARATOR

Participants randomised to the control arm will receive an education package and self-manage their glucose levels utilising a standard capillary blood glucose device, and keeping a glucose diary for the duration of the intervention period.

Combination Product: Capillary glucose monitoring and Education

Interventions

Flash Glucose Monitoring and Education COMBINATION_PRODUCT

Participants will wear the flash glucose monitoring system, and receive an education package on how to self-manage their glucose levels. They will use the flash glucose monitoring system continuously for 6 weeks. From week 6 to week 24, the frequency of use of flash glucose monitoring will be reduced to one sensor every 4 weeks. They will receive education at weeks 0, 2, 8 and 16. They will also wear a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). After the first 24 weeks, participants enter the observation phase (weeks 38 to 52) wherein they will be encouraged to continue monitoring their glucose levels through capillary glucose monitoring, during pre-meals and bedtime daily.

Flash Glucose Monitoring and Education

Capillary glucose monitoring and Education COMBINATION_PRODUCT

Participants will use a capillary glucose meter and receive an education package on how to self-manage their glucose levels. Participants will be encouraged to test their blood glucose levels at least twice a day, but preferably 4 times daily: pre-meal and bedtime blood glucose levels. They will receive education at weeks 0, 2, 8 and 16. They will wear a blinded sensor again after the last 2 weeks of the intervention period (week 24 to week 26). After the first 24 weeks, participants enter the observation phase (weeks 38 to 52) wherein they will be encouraged to continue monitoring their glucose levels through capillary glucose monitoring, during pre-meals and bedtime daily.

Capillary Glucose Monitoring and Education

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (Age \>21 years) with Type 2 diabetes (HbA1c 7.5 to 10% for 2 consecutive readings over the preceding 9 months 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)

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 for more than 3 times

Sponsors & Collaborators

• Singapore General Hospital: lead
• National University Hospital, Singapore: collaborator
• SingHealth Polyclinics: collaborator
• National Healthcare Group Polyclinics: collaborator
• National University Polyclinics, Singapore: collaborator

Study Sites (3)

Pasir Ris Polyclinic

Singapore, 519457, Singapore

Location

National Healthcare Group

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Daphne SL Gardner, MD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 25, 2020
• Study Start: December 22, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)