Gestational DiabetesI-HIPSNCT05081037
Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
A study testing Wearable Care Group in people with Gestational Diabetes and Glucose Metabolism Disorders, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
This study aims to test the following hypotheses in a randomized controlled trial of post-partum women with a history of gestational diabetes mellitus (GDM) that will be followed up for up to 4 years: 1. Post-partum pregnancy is ideal for behavioural modification and adopting a healthy lifestyle. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Glucose Metabolism Disorders, Metabolic Disease
- What is being tested?
- Wearable Care Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Sep 2021to 15 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women diagnosed antenatally with GDM by IADPSG criteria (15)
- Normal 6 weeks post-natal OGTT
- BMI range from 20-40
- Physically fit to participate in moderate intensity walking
Who cannot join
- Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days
- Women who have any other serious chronic disease such as chronic kidney disease and heart disease
Trial locations and contacts
1 site in 1 country.
Singapore1 site
KK Women's and Children's Hospital
Singapore, Singapore, 229899
About this study
Official title: Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus
This study aims to test the following hypotheses in a randomized controlled trial of post-partum women with a history of gestational diabetes mellitus (GDM) that will be followed up for up to 4 years:
- Post-partum pregnancy is ideal for behavioural modification and adopting a healthy lifestyle. Using the continous glucose monitoring (CGM) sensor and an exercise tracker will promote self-motivation and awareness by positive reinforcement and behavioural changes to improve diet, control body weight and increase physical activity in this group of post-partum women who are at high risk for developing Type II Diabetes.
- The use of the continous glycose monitoring (CGM) sensor and exercise tracker will motivate women to modify their dietary food intake and physical activity over time, reducing their cardiovascular risk factors for developing metabolic syndrome by lowering their baseline blood pressure, BMI, reducing their waist circumference and body fat mass, glycaemic levels and fasting lipids within the targeted healthy range.
- There will be an increase in the quality adjusted life years (QALYs) gained based on improvements in HbA1C and other proximal outcomes at the end of the trial.
Read the detailed description
The increased incidence of gestational diabetes mellitus (GDM) resulting from increased insulin resistance has become a major health concern. GDM affects 5-10% of pregnant women in Europe, while the prevalence in Asian populations is significantly higher at approximately 15-20%. There is a need for early postpartum intervention strategies beginning soon after birth, but yet there are limited of such intervention studies conducted in Asia.
This is a randomized controlled trial and hospital-based study. A total of 300 post-partum women who attended KK Women's and Children's Hospital (KKH) for antenatal consultation and were diagnosed with GDM using International association of diabetes and pregnancy study groups (IADPSG) guidelines at KKH, with a BMI range from 20-40, and physically fit to participate in moderate intensity walking will be approached for prospective recruitment. These subjects will be followed-up to determine if they will have normal oral glucose tolerance test (OGTT) results at 6 weeks postpartum. If all the inclusion criteria is met, these women will be recruited into the study.
The recruited women will be randomly allocated to the intervention or control group. Those placed in the intervention group, which will also be known as the Wearable Care Group, will receive both a continous glucose monitoring (CGM) and an exercise tracker which will be a FitBit watch. Those placed in the control group, which will also be known as the Scheduled Care Group will receive standard medical care.
Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group) will be followed up in the specialist outpatient clinics with a total of 7 visits for up to 4 years. Various testing will be carried out at relevant time points.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, a quality of life questionnaire, maternal diet, medical histories, lifestyle factors, health status, and home environment. Bio-physical measurements will be obtained from anthropometric measurements of participants, human biological materials such as blood, are collected from the participants at their follow-up time points with the I-HIPS study upon their consent.
- Being tested
- Wearable Care Group
- Keywords
- gestational diabetes, post-partum intervention, Body composition
- Medical subject headings
- Diabetes, Gestational, Glucose Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Care GroupDevice
Continous glucose monitoring sensor: Study participants wear the sensor on the back of either right or left upper arm for up to 14 days. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning.
Exercise tracker: A FitBit watch will be given to the participants for use to track physical activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Care Group | Experimental | This group will receive both a continous glucose monitoring sensor and an exercise tracker to be worn for at least 2 weeks at each study visit timepoint. Receives: Device: Wearable Care Group |
| Scheduled Care Group | No intervention | This group will receive standard medical care with dietary and nutritional advice alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Measured: At 6 months (23-26 weeks) from baseline visit
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Measured: At 10-14 months from baseline visit
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Measured: At 22-26 months from baseline visit
Clinically diagnosed Type II Diabetes Mellitus
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Measured: At 34-38 months from baseline visit
Body mass index at the end of the 6 month intervention period
Using weight and height measures
Measured: At 6 months (23-26 weeks) from baseline
Body fat mass at the end of the 6 month intervention period
Measured using the bioelectrical impedance analysis scale
Measured: At 6 months (23-26 weeks) from baseline
Secondary outcomes (18)
Change in total energy intake from baseline at 6 months (23-26 weeks)
Assess the effect of continous glucose monitoring sensor use on total energy intake calculated using data captured from the 24-Hour recall food diary.
Measured: Baseline and 6 months (23-26 weeks)
Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months
Assess the effect of continous glucose monitoring sensor use on total energy intake captured using data captured from the 24-Hour recall food diary.
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in diet quality from baseline at 6 months (23-26 weeks)
Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary.
Measured: Baseline and 6 months (23-26 weeks)
Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months
Assess the effect of continous glucose monitoring sensor use on diet quality derived using a 24-Hour recall food diary.
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in physical activity from baseline at 6 months (23-26 weeks)
Assess the effect of exercise tracker use on frequency and duration of physical activity using self-reported data from the International Physical Activity Questionnaire (IPAQ)
Measured: Baseline and 6 months (23-26 weeks)
Change in physical activity from baseline, 6 months, 12 months, 24 months and 36 months
Assess the effect of exercise tracker use on frequency and duration of physical activity using self-reported data from the International Physical Activity Questionnaire (IPAQ)
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in diastolic and systolic blood pressure measures from baseline at 6 months (23-26 weeks)
Using diastolic and systolic blood pressure measures
Measured: Baseline and 6 months (23-26 weeks)
Change in diastolic and systolic blood pressure measures from baseline, 6 months, 12 months, 24 months and 36 months
Using diastolic and systolic blood pressure measures
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in body mass index measures from baseline at 6 months (23-26 weeks)
Calculating body mass index using height and weight measures
Measured: Baseline and 6 months (23-26 weeks)
Change in body mass index measures from baseline, 6 months, 12 months, 24 months and 36 months
Calculating body mass index using height and weight measures
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in waist circumference measures from baseline at 6 months (23-26 weeks)
Using waist circumference measures
Measured: Baseline and 6 months (23-26 weeks)
Change in waist circumference measures from from baseline, 6 months, 12 months, 24 months and 36 months
Using waist circumference measures
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in body fat mass measures from baseline at 6 months (23-26 weeks)
Using body fat mass measured using the bioelectrical impedance analysis scale
Measured: Baseline and 6 months (23-26 weeks)
Change in body fat mass measures from baseline, 6 months, 12 months, 24 months and 36 months
Using body fat mass measured using the bioelectrical impedance analysis scale
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in HbA1c measures from baseline at 6 months (23-26 weeks)
Using HbA1c levels measured from blood samples
Measured: Baseline and 6 months (23-26 weeks)
Change in HbA1c measures from baseline, 6 months, 12 months, 24 months and 36 months
Using HbA1c levels measured from blood samples
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in fasting lipid profile from baseline at 6 months (23-26 weeks)
Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples
Measured: Baseline and 6 months (23-26 weeks)
Change in fasting lipid profile from baseline, 6 months, 12 months, 24 months and 36 months
Using fasting lipid profiles (total cholesterol, Low-density lipoprotein (LDL) cholesterol, High-density lipoprotein (HDL) cholesterol, triglycerides) of blood samples
Measured: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start6 Sep 2021
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group).
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Duke-NUS Graduate Medical School, Institute for Human Development and Potential (IHDP), Singapore
- Responsible party
- Sponsor
- Investigators
- Kok Hian Tan, MD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081037
- Sponsor's protocol ID
- 2020/3070
- Acronym
- I-HIPS
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2021
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quah PL, Song H, Han WM, Lim EJK, Bakar MAA, Fadzully F, Tan LK, Suzanna S, Eriksson JG, Chan SY, Finkelstein EA, Tan KH. Lifestyle intervention to prevent postpartum type 2 diabetes in Asian women with recent gestational diabetes and normal post-pregnancy glucose tolerance: study protocol for a randomized controlled trial with a targeted postpartum lifestyle programme. Trials. 2026 Feb 11;27(1):159. doi: 10.1186/s13063-026-09516-7.
PubMed 41673699
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions to Prevent Postpartum Type II Diabetes Mellitus in Asian Women With a History of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05081037
- Acronym / sponsor ID
- I-HIPS / 2020/3070
- Keywords
- gestational diabetes, post-partum intervention, Body composition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Duke-NUS Graduate Medical School, Institute for Human Development and Potential (IHDP), Singapore
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to test the following hypotheses in a randomized controlled trial of post-partum women with a history of gestational diabetes mellitus (GDM) that will be followed up for up to 4 years:
- Post-partum pregnancy is ideal for behavioural modification and adopting a healthy lifestyle. Using the continous glucose monitoring (CGM) sensor and an exercise tracker will promote self-motivation and awareness by positive reinforcement and behavioural changes to improve diet, control body weight and increase physical activity in this group of post-partum women who are at high risk for developing Type II Diabetes.
- The use of the continous glycose monitoring (CGM) sensor and exercise tracker will motivate women to modify their dietary food intake and physical activity over time, reducing their cardiovascular risk factors for developing metabolic syndrome by lowering their baseline blood pressure, BMI, reducing their waist circumference and body fat mass, glycaemic levels and fasting lipids within the targeted healthy range.
- There will be an increase in the quality adjusted life years (QALYs) gained based on improvements in HbA1C and other proximal outcomes at the end of the trial.
Detailed description
The increased incidence of gestational diabetes mellitus (GDM) resulting from increased insulin resistance has become a major health concern. GDM affects 5-10% of pregnant women in Europe, while the prevalence in Asian populations is significantly higher at approximately 15-20%. There is a need for early postpartum intervention strategies beginning soon after birth, but yet there are limited of such intervention studies conducted in Asia.
This is a randomized controlled trial and hospital-based study. A total of 300 post-partum women who attended KK Women's and Children's Hospital (KKH) for antenatal consultation and were diagnosed with GDM using International association of diabetes and pregnancy study groups (IADPSG) guidelines at KKH, with a BMI range from 20-40, and physically fit to participate in moderate intensity walking will be approached for prospective recruitment. These subjects will be followed-up to determine if they will have normal oral glucose tolerance test (OGTT) results at 6 weeks postpartum. If all the inclusion criteria is met, these women will be recruited into the study.
The recruited women will be randomly allocated to the intervention or control group. Those placed in the intervention group, which will also be known as the Wearable Care Group, will receive both a continous glucose monitoring (CGM) and an exercise tracker which will be a FitBit watch. Those placed in the control group, which will also be known as the Scheduled Care Group will receive standard medical care.
Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group) will be followed up in the specialist outpatient clinics with a total of 7 visits for up to 4 years. Various testing will be carried out at relevant time points.
Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, a quality of life questionnaire, maternal diet, medical histories, lifestyle factors, health status, and home environment. Bio-physical measurements will be obtained from anthropometric measurements of participants, human biological materials such as blood, are collected from the participants at their follow-up time points with the I-HIPS study upon their consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomized to both the control (Scheduled Care Group) and the intervention group (Wearable Care Group).
| Arm | Type | Receives |
|---|---|---|
| Wearable Care Group | Experimental | Device: Wearable Care GroupThis group will receive both a continous glucose monitoring sensor and an exercise tracker to be worn for at least 2 weeks at each study visit timepoint. |
| Scheduled Care Group | No intervention | –This group will receive standard medical care with dietary and nutritional advice alone. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women diagnosed antenatally with GDM by IADPSG criteria (15)
- Normal 6 weeks post-natal OGTT
- BMI range from 20-40
- Physically fit to participate in moderate intensity walking
Key exclusion criteria (2 listed)
- Women with serious skin conditions (e.g. eczema) that precludes wearing the sensor for 14 days
- Women who have any other serious chronic disease such as chronic kidney disease and heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Care GroupContinous glucose monitoring sensor: Study participants wear the sensor on the back of either right or left upper arm for up to 14 days. Glucose levels will be recorded from the interstitial fluid every 15 minutes using intermittent/ flash glucose scanning. Exercise tracker: A FitBit watch will be given to the participants for use to track physical activity levels. | Device | Wearable Care Group |
Primary outcome
Clinically diagnosed Type II Diabetes Mellitus
Time frame: At 6 months (23-26 weeks) from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Clinically diagnosed Type II Diabetes Mellitus
Time frame: At 10-14 months from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Clinically diagnosed Type II Diabetes Mellitus
Time frame: At 22-26 months from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Clinically diagnosed Type II Diabetes Mellitus
Time frame: At 34-38 months from baseline visit
Clinical outcomes of Type II Diabetes Mellitus development determined by oral glucose tolerance test
Body mass index at the end of the 6 month intervention period
Time frame: At 6 months (23-26 weeks) from baseline
Using weight and height measures
Body fat mass at the end of the 6 month intervention period
Time frame: At 6 months (23-26 weeks) from baseline
Measured using the bioelectrical impedance analysis scale
18 secondary outcomes
Change in total energy intake from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in total energy intake from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in diet quality from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in diet quality from baseline, 6 months,12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in physical activity from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in physical activity from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in diastolic and systolic blood pressure measures from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in diastolic and systolic blood pressure measures from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in body mass index measures from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in body mass index measures from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in waist circumference measures from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in waist circumference measures from from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in body fat mass measures from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in body fat mass measures from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in HbA1c measures from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in HbA1c measures from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Change in fasting lipid profile from baseline at 6 months (23-26 weeks)
Time frame: Baseline and 6 months (23-26 weeks)
Change in fasting lipid profile from baseline, 6 months, 12 months, 24 months and 36 months
Time frame: Baseline, 6 months (23-26 weeks), 12 months (10-14 months), 24 months (22-26 months) and 36 months (34-38 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 41673699Quah PL, Song H, Han WM, Lim EJK, Bakar MAA, Fadzully F, Tan LK, Suzanna S, Eriksson JG, Chan SY, Finkelstein EA, Tan KH. Lifestyle intervention to prevent postpartum type 2 diabetes in Asian women with recent gestational diabetes and normal post-pregnancy glucose tolerance: study protocol for a randomized controlled trial with a targeted postpartum lifestyle programme. Trials. 2026 Feb 11;27(1):159. doi: 10.1186/s13063-026-09516-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kok Hian Tan, MD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Care Group in people with Gestational Diabetes and Glucose Metabolism Disorders, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically diagnosed Type II Diabetes Mellitus (time frame: At 6 months (23-26 weeks) from baseline visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05081037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.