治験レーダー

Dietary intake

37-item Diet Screener (DS) The DS was designed and validated in a multi-ethnic population locally aged 18-79 years to assess intakes of selected food groups that could represent overall dietary patterns. The screener covers intakes of whole grains, soya protein, fruit, vegetables, oily fish and dairy fat and demonstrates reasonably good validity and reproducibility relative to the more accepted but longer 163-item Food Frequency Questionnaire. It is therefore easier to administer during the study with minimal participant burden.

0 weeks, 2-6 weeks, 24-28 weeks

Physical activity using International Physical Activity Questionnaire Short Form

a validated 7-item instrument that measures an individual's physical activity in the last 7 days; measures metabolic equivalent of task (MET)-minutes per week. Participants are asked to report the days and time they spent in the last 7 days in 4 categories: vigorous activity (heavy lifting, aerobics, fast bicycling), moderate activity (light lifting, moderate bicycling), walking, and sitting (watching TV, reading). The total physical activity was calculated as the sum of the vigorous, moderate, and walking categories in metabolic equivalent minutes per week (MET-min per week scores). Questions on sitting are related to sedentariness and are scored separately. MET minutes represent the amount of energy expended carrying out physical activity. One MET is what the participants expend when they rest. To get a continuous variable score it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher score, better outcome.

0 weeks, 2-6 weeks, 24-28 weeks

Body weight

Weight in kilograms

0 week, 24-28 weeks

Height

Height in meters

0 week, 24-28 weeks

Body Mass Index

Weight and Height will be combined to report Body Mass Index in kg/m\^2

0 week, 24-28 weeks

Waist circumference

Waist circumference in centimeters: Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest with a measuring tape. The mean value of two waist circumference measurements is used. Both measurements are repeated if there is a difference of more than 1 cm.

0 week, 24-28 weeks

Participant recruitment numbers

Number of participants recruited for the control and intervention arm. The study targets to recruit 76 participants over a 6-month recruitment period.

6 months recruitment period

Drop-out rate

Number of participants that dropped out of the study. Drop-out rate is calculated based on the proportion of enrolled participants who do not complete the intervention/1-month follow-up/6-month follow-up. The study targets for a drop-out rate of \< 20%.

18 months study duration

Adherence rate to the sensor

Intervention group participants usage of CGM over the two-week period. Statistics on sensor adherence will be obtained from the Abbott Freestyle Libre system and is determined as \>70% CGM use in the 2 weeks it is worn (≥10 readings over 2 weeks).

2-6 weeks

Exploring views on the facilitators and barriers of behavioral change with CGM

In-depth interviews with the intervention group participants

24-28 weeks, to allow up to 36 weeks

Views and experiences of using CGM with the Abbott Freestyle Libre system

In-depth interviews with the intervention group participants

24-28 weeks, to allow up to 36 weeks

Views and experiences on the study protocol

In-depth interviews with the intervention group participants

24-28 weeks, to allow up to 36 weeks

Experiences with managing adults with prediabetes

Interviews with HCP participants till point of data saturation

Baseline, up to 60 minutes

Knowledge and experience with CGM

Interviews with HCP participants till point of data saturation

Baseline, up to 60 minutes

Views on using CGM in adults with prediabetes

Interviews with HCP participants till point of data saturation

Baseline, up to 60 minutes

Facilitators and barriers to offering CGM as part of prediabetes management to their patients

Interviews with HCP participants till point of data saturation

Baseline, up to 60 minutes