Diabetes Mellitus, Type 2iCUDENCT05319496
isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes
A study testing Intermittently scanned continuous glucose monitor (isCGM) and Education and coaching in people with Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
Trial summary
Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses a wearable sensor that continuously measures… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Intermittently scanned continuous glucose monitor (isCGM) and Education and coaching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2022to 12 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years with type 2 diabetes.
- HbA1c > 7.0% within the last 6 months.
- Non-insulin therapy.
- Able to attend two in-person study visits.
- English-speaking.
- Community-dwelling
- In possession of a cell phone capable of accessing the internet and receiving FreeStyle Libre 2 sensor readings
- Has a primary care provider who has been in contact with the patient for diabetes in the last 12 months.
Who cannot join
- Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.: MODY).
- Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 3 months.
- Pregnancy; plans to become pregnant within 6 months; breast-feeding.
- Any use of insulin in the previous year.
- Current or previous use of isCGM or rtCGM within the last 6 months.
- Cognitive dysfunction (SPMSQ score >= 5).
Show all 12Show fewer
- Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and weight loss, accompanied by acute fatigue or dyspnea).
- Any terminal condition that would limit life expectancy to < 1 year.
- Inability to use isCGM (e.g.: afraid of the device).
- Inability to be reached by telephone.
- Concurrent participation in a different diabetes-related trial.
- Has not already received two doses of a Health Canada-approved vaccine against SARS-CoV-2.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta Hospital / Kaye Edmonton Clinic
Edmonton, Alberta, T6G 1Z1
About this study
Official title: Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial
Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses a wearable sensor that continuously measures glucose levels under the skin. With intermittently scanned CGM (isCGM), patients scanning the sensor to obtain readings. isCGM is painless, provides information on glucose trends, and has improves patient satisfaction.
Most adults with diabetes are not on insulin. Yet, the effectiveness of CGM is not well studied in this population. In this randomized trial, we are looking for adults with type 2 diabetes, who need further blood glucose lowering (HbA1c > 7.0%), who are not yet on insulin. Participants randomized to the treatment group (50%) will receive isCGM with individual coaching; those in the the enhanced usual care group (50%) will receive diabetes coaching only. The intervention will feature three FreeStyle Libre 2 (Abbott Laboratories, IL) sensors (6 weeks), and is intended to be affordable and applicable to a wide range of adults with diabetes under real world conditions.
Read the detailed description
Objective: To evaluate the effectiveness of intermittently scanned continuous glucose monitoring (isCGM) with education and feedback on glycemic control at 12 weeks, in adults with type 2 diabetes and uncontrolled HbA1c (> 7.0%) not on insulin therapy.
Background: Continuous glucose monitoring (CGM) has been shown to reduce hypoglycemia in adults on insulin. The effectiveness of CGM in adults with type 2 diabetes not on insulin therapy has not been well studied. We hypothesize that isCGM linked to structured education - specifically one-on-one review and feedback of glucose values with a diabetes educator - can improve HbA1c via a combination of improved lifestyle choices and accelerated medication intensification, in adults with earlier T2DM. To test this hypothesis, we propose a randomized controlled trial of isCGM + structured education, versus enhanced usual care with structured education only.
Methods: Open-label, 12-week, single-center randomized controlled trial. Included adults will be randomized 1:1 to intervention or enhanced usual care. Intervention participants will receive three FreeStyle Libre 2 (Abbott Laboratories, IL) isCGM sensors to be applied over weeks 1-6. Diabetes education and coaching will be provided at the beginning and end of the sensor period. The control group will receive diabetes education and coaching during weeks 1-2 and 5-6, but not the isCGM sensors. The primary outcome (HbA1c change from baseline) will be measured by venous blood draw at 12 weeks. Participants will be asked to complete patient-reported outcome instruments for secondary outcomes, e.g.: diabetes self-empowerment, diet, and physical activity - at baseline, 6 weeks, and 12 weeks.
Significance: This trial will examine the effectiveness of scheduled, intermittent use of isCGM sensors for type 2 diabetes, when combined with education and feedback. The intervention is designed to be affordable and applicable to a wide range of adults with diabetes, and may have significant implications for the use of isCGM.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Intermittently scanned continuous glucose monitor (isCGM), Education and coaching
- Keywords
- continuous glucose monitoring, flash glucose monitoring, intermittently scanned continuous glucose monitoring, CGM, non-insulin dependent diabetes
- 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.
Intermittently scanned continuous glucose monitor (isCGM)Device
Also called Flash glucose monitor
A wearable sensor the size of 2 stacked quarters, that allows individuals to "scan" their glucose levels on demand. No fingerstick is required. The device measure interstitial glucose through a filament that is inserted under the skin. The application process is painless, and each sensor lasts 90 days. Sensors can be scanned with certain smart phones. This device is marketed as the FreeStyle Libre 2 glucometer (Abbott Laboratories, IL).
Education and coachingBehavioural
Two encounters with a certified diabetes educator, who will assess lifestyle and medications, and provide individualized advice on diet, physical activity, and medication changes to improve glycemic control.
| Study group | Role | What they receive |
|---|---|---|
| isCGM with education and feedback | Experimental | Intervention subjects will receive three isCGM sensors (FreeStyle Libre 2, Abbott Laboratories) for use over weeks 1-6. They will have encounters with a diabetes educator for individualized education and coaching during weeks 1-2 and 5-6. Receives: Device: Intermittently scanned continuous glucose monitor (isCGM); Behavioral: Education and coaching |
| Enhanced usual care with education and feedback only | Active comparator | Enhanced usual care subjects will receive two encounters with a diabetes educator for individualized education and coaching, during weeks 1-2 and 5-6. They will not be provided with isCGM sensors. Receives: Behavioral: Education and coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c assessed by venous blood draw, compared to baseline.
Measured: 12 weeks
Secondary outcomes (8)
Diabetes treatment satisfaction
Difference in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from baseline (DTSQs scores range 0-36, higher indicating better treatment satisfaction); DTSQc "change" score at 6 weeks.
Measured: 6 weeks and 12 weeks
Diabetes self-care empowerment
Change in Diabetes Empowerment Scale - Short Form (DES-SF) score from baseline. DES-SF score ranges 1-5, higher scores indicating greater self-care empowerment.
Measured: 6 weeks and 12 weeks
Diabetes-related distress
Change in Problem Areas in Diabetes Questionnaire (PAID) score from baseline. PAID score ranges 0-100, a score above 40 indicates severe diabetes distress.
Measured: 6 weeks and 12 weeks
Healthy diet
Change in UK Diabetes and Diet Questionnaire (UKDDQ) score from baseline. UKDDQ score ranges 0-5 with higher scores indicating more healthy dietary choices.
Measured: 6 weeks and 12 weeks
Physical activity
Change in International Physical Activity Questionnaire (IPAQ) short form score. IPAQ score estimates total metabolic equivalent-minutes per week, with higher scores indicating more a more physically active individual.
Measured: 6 weeks and 12 weeks
Health-related quality of life
Change in Euroqol EQ-5D-5L health utility score from baseline. EQ-5D scores range from 0-100, with 100 indicating a state of perfect health.
Measured: 6 weeks and 12 weeks
Emergency department visits
Number of emergency department visits during the 12-week trial period.
Measured: 12 weeks
Hospital admissions
Number of hospital admissions during the 12-week trial period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start5 Oct 2022
- Primary completion15 Jan 2024
- Study completion12 Mar 2024
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiology Coordinating and Research Centre, Canada
- Responsible party
- Sponsor
- Investigators
- Darren Lau, MD/PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319496
- Sponsor's protocol ID
- Pro00119503
- Acronym
- iCUDE
- Status last verified
- Feb 2025
- First submitted
- 31 Mar 2022
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olu-Jordan I, Singh P, Zhang JR, Yeung RO, Manca DP, Perry T, Rahim G, Hagen E, Lau D. The Effects of Continuous Glucose Monitoring on Patient-reported Outcomes in Adults With Non-Insulin-dependent Type 2 Diabetes: A Randomized Controlled Trial. Can J Diabetes. 2026 Feb;50(1):30-37.e2. doi: 10.1016/j.jcjd.2025.10.174. Epub 2025 Oct 27.
PubMed 41161400
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial
- ClinicalTrials.gov ID
- NCT05319496
- Acronym / sponsor ID
- iCUDE / Pro00119503
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- continuous glucose monitoring, flash glucose monitoring, intermittently scanned continuous glucose monitoring, CGM, non-insulin dependent diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Epidemiology Coordinating and Research Centre, Canada
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 8 Apr 2022 (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.
Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses a wearable sensor that continuously measures glucose levels under the skin. With intermittently scanned CGM (isCGM), patients scanning the sensor to obtain readings. isCGM is painless, provides information on glucose trends, and has improves patient satisfaction.
Most adults with diabetes are not on insulin. Yet, the effectiveness of CGM is not well studied in this population. In this randomized trial, we are looking for adults with type 2 diabetes, who need further blood glucose lowering (HbA1c > 7.0%), who are not yet on insulin. Participants randomized to the treatment group (50%) will receive isCGM with individual coaching; those in the the enhanced usual care group (50%) will receive diabetes coaching only. The intervention will feature three FreeStyle Libre 2 (Abbott Laboratories, IL) sensors (6 weeks), and is intended to be affordable and applicable to a wide range of adults with diabetes under real world conditions.
Detailed description
Objective: To evaluate the effectiveness of intermittently scanned continuous glucose monitoring (isCGM) with education and feedback on glycemic control at 12 weeks, in adults with type 2 diabetes and uncontrolled HbA1c (> 7.0%) not on insulin therapy.
Background: Continuous glucose monitoring (CGM) has been shown to reduce hypoglycemia in adults on insulin. The effectiveness of CGM in adults with type 2 diabetes not on insulin therapy has not been well studied. We hypothesize that isCGM linked to structured education - specifically one-on-one review and feedback of glucose values with a diabetes educator - can improve HbA1c via a combination of improved lifestyle choices and accelerated medication intensification, in adults with earlier T2DM. To test this hypothesis, we propose a randomized controlled trial of isCGM + structured education, versus enhanced usual care with structured education only.
Methods: Open-label, 12-week, single-center randomized controlled trial. Included adults will be randomized 1:1 to intervention or enhanced usual care. Intervention participants will receive three FreeStyle Libre 2 (Abbott Laboratories, IL) isCGM sensors to be applied over weeks 1-6. Diabetes education and coaching will be provided at the beginning and end of the sensor period. The control group will receive diabetes education and coaching during weeks 1-2 and 5-6, but not the isCGM sensors. The primary outcome (HbA1c change from baseline) will be measured by venous blood draw at 12 weeks. Participants will be asked to complete patient-reported outcome instruments for secondary outcomes, e.g.: diabetes self-empowerment, diet, and physical activity - at baseline, 6 weeks, and 12 weeks.
Significance: This trial will examine the effectiveness of scheduled, intermittent use of isCGM sensors for type 2 diabetes, when combined with education and feedback. The intervention is designed to be affordable and applicable to a wide range of adults with diabetes, and may have significant implications for the use of isCGM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isCGM with education and feedback | Experimental | Device: Intermittently scanned continuous glucose monitor (isCGM), Behavioral: Education and coachingIntervention subjects will receive three isCGM sensors (FreeStyle Libre 2, Abbott Laboratories) for use over weeks 1-6. They will have encounters with a diabetes educator for individualized education and coaching during weeks 1-2 and 5-6. |
| Enhanced usual care with education and feedback only | Active comparator | Behavioral: Education and coachingEnhanced usual care subjects will receive two encounters with a diabetes educator for individualized education and coaching, during weeks 1-2 and 5-6. They will not be provided with isCGM sensors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 18 years with type 2 diabetes.
- HbA1c > 7.0% within the last 6 months.
- Non-insulin therapy.
- Able to attend two in-person study visits.
- English-speaking.
Key exclusion criteria (12 listed)
- Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.: MODY).
- Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 3 months.
- Pregnancy; plans to become pregnant within 6 months; breast-feeding.
- Any use of insulin in the previous year.
- Current or previous use of isCGM or rtCGM within the last 6 months.
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 |
|---|---|---|
| Intermittently scanned continuous glucose monitor (isCGM)Also: Flash glucose monitorA wearable sensor the size of 2 stacked quarters, that allows individuals to "scan" their glucose levels on demand. No fingerstick is required. The device measure interstitial glucose through a filament that is inserted under the skin. The application process is painless, and each sensor lasts 90 days. Sensors can be scanned with certain smart phones. This device is marketed as the FreeStyle Libre 2 glucometer (Abbott Laboratories, IL). | Device | isCGM with education and feedback |
| Education and coachingTwo encounters with a certified diabetes educator, who will assess lifestyle and medications, and provide individualized advice on diet, physical activity, and medication changes to improve glycemic control. | Behavioural | Enhanced usual care with education and feedback only, isCGM with education and feedback |
Primary outcome
Change in HbA1c
Time frame: 12 weeks
Change in HbA1c assessed by venous blood draw, compared to baseline.
8 secondary outcomes
Diabetes treatment satisfaction
Time frame: 6 weeks and 12 weeks
Diabetes self-care empowerment
Time frame: 6 weeks and 12 weeks
Diabetes-related distress
Time frame: 6 weeks and 12 weeks
Healthy diet
Time frame: 6 weeks and 12 weeks
Physical activity
Time frame: 6 weeks and 12 weeks
Health-related quality of life
Time frame: 6 weeks and 12 weeks
Emergency department visits
Time frame: 12 weeks
Hospital admissions
Time frame: 12 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 6 Feb 2025.
- Derived from this study: PubMed 41161400Olu-Jordan I, Singh P, Zhang JR, Yeung RO, Manca DP, Perry T, Rahim G, Hagen E, Lau D. The Effects of Continuous Glucose Monitoring on Patient-reported Outcomes in Adults With Non-Insulin-dependent Type 2 Diabetes: A Randomized Controlled Trial. Can J Diabetes. 2026 Feb;50(1):30-37.e2. doi: 10.1016/j.jcjd.2025.10.174. Epub 2025 Oct 27.
- 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.
Darren Lau, MD/PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittently scanned continuous glucose monitor (isCGM) and Education and coaching in people with Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
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 8 inclusion and 12 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 6 Feb 2025. 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 Canada. 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?
Change in HbA1c (time frame: 12 weeks). 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 NCT05319496, 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 Feb 2025.