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Completed

NCT Number: NCT04588896

Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, Shatin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Continuous glucose monitoring

Device

Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme

Lifestyle modification programme

Behavioral

Lifestyle modification programme

Primary outcomes

  1. 1-hour glucose from OGTT

    Time frame: 12 months

    1-hour plasma glucose from a 75 g oral glucose tolerance test

Secondary outcomes

  1. HbA1c

    Time frame: 12 months

    Between-group differences in HbA1c

  2. Fasting plasma glucose

    Time frame: 12 months

    Between-group differences in fasting plasma glucose

  3. Body weight

    Time frame: 12 months

    Between-group differences in body weight

  4. Body mass index

    Time frame: 12 months

    Between-group differences in body mass index

  5. Waist circumference

    Time frame: 12 months

    Between-group differences in waist circumference

  6. 3 day diet record

    Time frame: 12 months

    Differences in daily nutrient intake between groups

  7. Physical activity levels

    Time frame: 12 months

    Daily number of steps as measured by a sealed pedometer

  8. Socio-cognitive measures

    Time frame: 12 months

    Self-efficacy questionnaire

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: FlashLMP

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2020
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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