The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program

Not Applicable

Completed

• Conditions: Pre-diabetes
• Interventions: Behavioral: Lifestyle modification; Drug: Metformin; Other: Financial incentives

• Registration Number: NCT03503942
• Lead Sponsor: Singapore General Hospital

Brief Summary

The Pre-DICTED (Pre-Diabetes Intervention and Continued Tracking to Ease-out Diabetes) program is a community-based diabetes prevention program. This study aims to test the effectiveness of structured, group-based lifestyle interventions with stepwise addition of metformin, if required, among subjects with pre-diabetes in multi-ethnic Singapore.

Detailed Description

The Pre-DICTED program is designed as a randomized, controlled, pragmatic trial. The program targets to recruit up to 846 overweight/obese (BMI ≥23.0) adults (age 18-64) with isolated impaired fasting glucose (IFG), isolated impaired glucose tolerance (IGT), or IFG + IGT in Singapore. The follow-up period will be 3 years.

Eligible subjects will be identified through community, primary care clinics and hospital-based diabetes screening program. Following informed consent, eligible participants will be randomised into the control or the treatment arm.

Participants in the control arm will receive the current standard of care for pre-diabetes which includes counseling on lifestyle modifications and follow up by primary care physicians.

Participants in the treatment arm will undergo a 3-month, locally tailored, group-based lifestyle intervention program (consisting of nutrition workshops, exercise sessions and goal-setting workshop) plus subsequent stepwise addition of metformin for selected participants at the highest risk of progression to diabetes at ≥ 6 months of follow-up. Financial incentives will be awarded to participants who achieve weight lost of ≥5% of baseline weight during follow-up period.

The primary outcome of diabetes incidence will be assessed bi-annually and compared across the study arms. Secondary outcomes will include weight, waist circumference, fasting plasma glucose (FPG), 2-h glucose, HbA1c, physical activity, diet and metformin adherence.

Study Timeline

• Study First Submitted: 2017-10-13
• Study Start: 2017-12-30
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-20
• Primary Completion: 2024-03-31
• Status Verified: 2024-04
• Study Completion: 2024-04-15
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751

Inclusion Criteria

1. Singapore citizens or permanent residents

2. Age between 18 and 64

3. Body mass index (BMI) ≥ 23.0 kg/m2

4. Pre-diabetes diagnosed based on:

   1. fasting plasma glucose 6.1 - 6.9 mmol/L (Impaired fasting glucose; IFG) and/or
   2. 2-hr plasma glucose in 75g oral glucose tolerance test (OGTT) 7.8 - 11.0 mmol/L (Impaired glucose tolerance; IGT) (Laboratory tests to be done within 6 months of enrolment)

Exclusion Criteria

1. Individuals with diabetes mellitus
2. Health conditions impeding participation in lifestyle change programme (e.g. active cancer, recent myocardial event within 6 months, heart failure, chronic kidney disease)
3. Current pregnancy or breast feeding
4. Treatment with medications known to alter glucose tolerance
5. Known allergic reaction to metformin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	Lifestyle modification	Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.
Treatment arm	Financial incentives	Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.
Treatment arm	Metformin	Participants in the treatment arm will receive structured group-based lifestyle interventions with stepwise addition of metformin for selected high-risk participants.

Primary Outcome Measures

Name	Time	Method
Diabetes incidence	3 years	The primary outcome, diabetes incidence, will be diagnosed based on a single, annual OGTT or the semi-annual FPG (Fasting plasma glucose) test

Secondary Outcome Measures

Name	Time	Method
Waist circumference	3 years	Waist circumference in cm
HbA1c	3 years	HbA1c in %
Fasting plasma glucose	3 years	Fasting plasma glucose in mmol/L
2-hour plasma glucose	3 years	2-hour plasma glucose post oral glucose challenge in mmol/L
International physical activity questionnaire (IPAQ) score	3 years	IPAQ score in MET minutes a week
Metformin adherence	Up to 30 months	Metformin adherence assessed by pill counts
Weight	3 years	Weight in kg

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore