Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes

Study Overview
=================
Brief Summary
-----------------
This is a 12-month prospective, open-label, non-masked, two arm randomized controlled trial comparing intermittently-viewed continuous glucose monitoring (iCGM) in addition to lifestyle modification programme (LMP) as compared with a LMP alone in individulas with impaired glucose tolerance (IGT). Following informed consent, participants will undergo screening where a fasting glucose, 75g OGTT, HbA1c, fasting lipid profile along with comprehensive medical and drug history to confirm eligibility. At week 0, participants will be randomised to CGM plus LMP versus LMP alone. Both groups will receive individualized structured LMP programme delivered by a dietitian and a fitness instructor. Outcomes will be evaluated by laboratory tests, physical measurement, physical activity and dietary compliance and questionnaires at Month 0, 4, 8, 12.

Official Title
-----------------
Continuous Glucose Monitoring as an Adjunct to Lifestyle Modification in Individuals With Impaired Glucose Tolerance: a Randomised Controlled Trial

Conditions
-----------------
PreDiabetes

Intervention / Treatment
-----------------
* Device: Continuous glucose monitoring
* Behavioral: Lifestyle modification programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaired glucose tolerance as defined by will be defined as per the American Diabetes Association criteria based on 75g oral glucose tolerance test (OGTT) 2-hour glucose of between 7.8 and less than 11 mmol/L Male or female age ≥ 18 years old and ≤ 65 years old. BMI 18 to 40kg/m2 Willingness, ability and commitment to comply with LMP Able to use a CGM as judged by investigator In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate. Written informed consent to participate in the study provided by the patient. Exclusion Criteria: Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy Known diabetes Current or previous use of glucose-lowering or weight loss drugs Concurrent participation in other weight loss or lifestyle intervention programmes Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device. Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis). Known uncontrolled thyrotoxicosis Current use of steroids Have a known allergy to medical-grade adhesives Known current or recent alcohol or drug abuse Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM+LMP<br>Continuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification | Device: Continuous glucose monitoring<br>* Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme<br>Behavioral: Lifestyle modification programme<br>* Lifestyle modification programme<br>|
| Other: LMP only<br>Lifestyle modification only | Behavioral: Lifestyle modification programme<br>* Lifestyle modification programme<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-hour glucose from OGTT | 1-hour plasma glucose from a 75 g oral glucose tolerance test | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Between-group differences in HbA1c | 12 months | 
| Fasting plasma glucose | Between-group differences in fasting plasma glucose | 12 months | 
| Body weight | Between-group differences in body weight | 12 months | 
| Body mass index | Between-group differences in body mass index | 12 months | 
| Waist circumference | Between-group differences in waist circumference | 12 months | 
| 3 day diet record | Differences in daily nutrient intake between groups | 12 months | 
| Physical activity levels | Daily number of steps as measured by a sealed pedometer | 12 months | 
| Socio-cognitive measures | Self-efficacy questionnaire | 12 months |