Clinical trial NCT04588896: Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes
Official title: Continuous Glucose Monitoring as an Adjunct to Lifestyle Modification in Individuals With Impaired Glucose Tolerance: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Male or female age ≥ 18 years old and ≤ 65 years old.
3. BMI 18 to 40kg/m2
4. Willingness, ability and commitment to comply with LMP
5. Able to use a CGM as judged by investigator
6. 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.
7. Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

1. Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
2. Known diabetes
3. Current or previous use of glucose-lowering or weight loss drugs
4. Concurrent participation in other weight loss or lifestyle intervention programmes
5. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
6. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
7. 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.
8. 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).
9. Known uncontrolled thyrotoxicosis
10. Current use of steroids
11. Have a known allergy to medical-grade adhesives
12. Known current or recent alcohol or drug abuse
13. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
14. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Primary outcomes:
measure: 1-hour glucose from OGTT
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: Fasting plasma glucose
timeFrame: 12 months
measure: Body weight
timeFrame: 12 months
measure: Body mass index
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: 3 day diet record
timeFrame: 12 months
measure: Physical activity levels
timeFrame: 12 months
measure: Socio-cognitive measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
affiliation: Chinese University of Hong Kong
name: Elaine Chow
role: PRINCIPAL_INVESTIGATOR
References: