Diabetes Mellitus, Type 2GLiMPSENCT03837262
GLucose Monitoring Programme SingaporeE (GLiMPSE)
A study testing Flash Glucose Monitoring and structured education in people with Diabetes Mellitus, Type 2, run by Singapore General Hospital at 3 sites in Singapore.
Trial summary
This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to evaluate the feasibility and acceptability of the flash glucose monitoring system together with a structured education programme in individuals with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Flash Glucose Monitoring and structured education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesSingapore
- Study dates
- 25 Mar 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults
- Adults (Age > 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)
- Singapore Citizen or Permanent Resident
- Treatment with diet and exercise alone or other glucose-lowering therapies except prandial insulin. GLP-1 agonists and / or basal insulin (NPH insulin, Insulin Lantus, Insulin Toujeo, Insulin Detemir) are permitted.
- Self-reported regular blood glucose testing via CBG (more than 3/week)
- Children
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- Children and adolescents (Age between 12 and 21 years old) with Type 2 diabetes and HbA1c >8% at the time of enrolment
- Singapore Citizen or Permanent Resident
- Insulin replacement as part of diabetes management
Who cannot join
- Age above 75 years
- Type 1 diabetes, monogenic diabetes
- Prandial insulin (quick-acting insulin or premixed insulin)
- Cancer requiring treatment in the past 5 years
- Chronic renal failure (eGFR<45ml/min) or dialysis
- Amputation of lower limbs (excluding toe amputations)
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- Bariatric surgery for weight loss
- Current systemic treatment with steroids
- Pregnancy, attempting pregnancy or lactation.
- Haemolytic anaemia or haemoglobinopathy
- Prior use of the flash glucose monitoring system
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
Singapore General Hospital
Singapore, 169856
KKH
Singapore, 229899
Pasir Ris Polyclinic
Singapore, 519457
About this study
Official title: GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1
This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to evaluate the feasibility and acceptability of the flash glucose monitoring system together with a structured education programme in individuals with Type 2 Diabetes.
Read the detailed description
Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore.
For Adults, this phase consists of screening and intervention periods.
Screening Period (Week -2 to -1):
Participants will be asked to wear a blinded flash glucose monitoring system and will be asked to continue testing their capillary glucose readings at least once daily for 2 weeks (week -2 to week -1). Sensor glucose measurements are not available to both participants and investigators during this screening period. Participants who are able to wear the sensor for the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for the 2 weeks (>10 readings/2weeks), will proceed on with the intervention period.
Intervention Period (Week 0 - 26):
Participants will wear a personal version of the flash glucose monitoring system continuously for the next 6 weeks. After these 6 weeks, they will wear the sensor intermittently (one sensor lasting 2 weeks, per 4 weeks) for the following 18 weeks.Participants in this arm will receive an education package that consists of Diabetes nurse educator and/or dietitian appointments during weeks 0, 2, 6 and 24. After week 24, they will put on a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). HbA1c will be monitored at weeks 0, 14 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user.
Paediatric participants will not undergo blinded sensor wear but will undergo the intervention period, with the schedule of wear identical to the adults'. The education curriculum will be age-appropriate and will be delivered over weeks 0, 2, 6, 12, and 24. Their HbA1c will be monitored at week 0, 12 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Flash Glucose Monitoring and structured education
- Keywords
- Flash Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flash Glucose Monitoring and structured educationCombination product
A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children
| Study group | Role | What they receive |
|---|---|---|
| Flash glucose monitoring | Experimental | Flash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education Receives: Combination Product: Flash Glucose Monitoring and structured education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention
Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites
Measured: 26 weeks
Secondary outcomes (5)
Questionnaire
Questionnaire to assess the acceptability of wear of the flash glucose monitoring system
Measured: 24 weeks
HbA1c
Measurement of HbA1c will be performed at baseline, week 12 and week 24
Measured: 24 weeks
DSS questionnaire
Diabetes Distress scale to be administered at baseline and week 24
Measured: 24 weeks
EQ-5D-5L Questionnaire
EQ-5D-5L Questionnaire to be administered at baseline and week 24
Measured: 24 weeks
WPAI questionnaire
Work Productivity and Activity impairment questionnaire to be administered at baseline and week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start25 Mar 2019
- Primary completion23 Jan 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Singapore General 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KK Women's and Children's Hospital, SingHealth Polyclinics
- Responsible party
- Sponsor
- Investigators
- Daphne SL Gardner, MD, Principal investigator, Singapore General Hospital, SingHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837262
- Sponsor's protocol ID
- GLiMPSE-POC1
- Acronym
- GLiMPSE
- Status last verified
- Sep 2020
- First submitted
- 7 Feb 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1
- ClinicalTrials.gov ID
- NCT03837262
- Acronym / sponsor ID
- GLiMPSE / GLiMPSE-POC1
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Flash Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- KK Women's and Children's Hospital, SingHealth Polyclinics
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 12 Feb 2019 (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 phase 1 study is a non-randomized, single-arm, multi-center study that is designed to evaluate the feasibility and acceptability of the flash glucose monitoring system together with a structured education programme in individuals with Type 2 Diabetes.
Detailed description
Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore.
For Adults, this phase consists of screening and intervention periods.
Screening Period (Week -2 to -1):
Participants will be asked to wear a blinded flash glucose monitoring system and will be asked to continue testing their capillary glucose readings at least once daily for 2 weeks (week -2 to week -1). Sensor glucose measurements are not available to both participants and investigators during this screening period. Participants who are able to wear the sensor for the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for the 2 weeks (>10 readings/2weeks), will proceed on with the intervention period.
Intervention Period (Week 0 - 26):
Participants will wear a personal version of the flash glucose monitoring system continuously for the next 6 weeks. After these 6 weeks, they will wear the sensor intermittently (one sensor lasting 2 weeks, per 4 weeks) for the following 18 weeks.Participants in this arm will receive an education package that consists of Diabetes nurse educator and/or dietitian appointments during weeks 0, 2, 6 and 24. After week 24, they will put on a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). HbA1c will be monitored at weeks 0, 14 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user.
Paediatric participants will not undergo blinded sensor wear but will undergo the intervention period, with the schedule of wear identical to the adults'. The education curriculum will be age-appropriate and will be delivered over weeks 0, 2, 6, 12, and 24. Their HbA1c will be monitored at week 0, 12 and 24. Questionnaires will be administered to assess acceptability of wear, and perceived value to the end-user.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study assessing the use of flash glucose monitoring together with structured education to improve outcomes in Type 2 diabetes.
| Arm | Type | Receives |
|---|---|---|
| Flash glucose monitoring | Experimental | Combination Product: Flash Glucose Monitoring and structured educationFlash glucose monitoring continuously for 6 weeks then once a month up to 24 weeks, with structured education |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Adults
- Adults (Age > 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)
- Singapore Citizen or Permanent Resident
- Treatment with diet and exercise alone or other glucose-lowering therapies except prandial insulin. GLP-1 agonists and / or basal insulin (NPH insulin, Insulin Lantus, Insulin Toujeo, Insulin Detemir) are permitted.
- Self-reported regular blood glucose testing via CBG (more than 3/week)
Key exclusion criteria (11 listed)
- Age above 75 years
- Type 1 diabetes, monogenic diabetes
- Prandial insulin (quick-acting insulin or premixed insulin)
- Cancer requiring treatment in the past 5 years
- Chronic renal failure (eGFR<45ml/min) or dialysis
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 |
|---|---|---|
| Flash Glucose Monitoring and structured educationA feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children | Combination product | Flash glucose monitoring |
Primary outcome
Recruitment and retention
Time frame: 26 weeks
Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites
5 secondary outcomes
Questionnaire
Time frame: 24 weeks
HbA1c
Time frame: 24 weeks
DSS questionnaire
Time frame: 24 weeks
EQ-5D-5L Questionnaire
Time frame: 24 weeks
WPAI questionnaire
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Daphne SL Gardner, MD principal investigator
Singapore General Hospital, SingHealth
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flash Glucose Monitoring and structured education in people with Diabetes Mellitus, Type 2, run by Singapore General Hospital at 3 sites 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 9 inclusion and 11 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: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment and retention (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2020.