Type 2 Diabetes on InsulinPhase 4BENEFIT-KSANCT07603284
Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi Arabia
A Phase 4 study testing Real-Time Continuous Glucose Monitoring in people with Type 2 Diabetes on Insulin, run by DexCom, Inc. at 1 site in Saudi Arabia.
Trial summary
This study aims to understand how using real-time continuous glucose monitoring (RT-CGM) can help people with Type-2 diabetes on insulin in Saudi Arabia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes on Insulin
- What is being tested?
- Real-Time Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Nov 2025to 31 Dec 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age of at least 18 years at time of screening. 2. Type 2 diabetes and on either intensive insulin therapy (IIT) or basal insulin therapy for ≥6 months prior to entry.
- IIT: Defined as basal insulin + ≥2 daily bolus injections of rapid acting insulin or ≥2 injections per day of premixed insulin (e.g. 70/30 or 50/50).
- Basal: Defined as ≤2 injections per day of basal insulin only and not planning to start rapid acting or premixed insulin in the next 6 months.
- 3. Screening HbA1c ≥8% at enrollment (by local lab at time of screening). 4. Assessment by clinician that participant is thought to be able and willing to wear, and motivated to engage with, a CGM device.
- 5. No personal real-time or intermittent scanned (Flash) CGM use, or use of a glucose biosensor 3 months prior to enrolment.
- 6. Stable diabetes, lipid lowering, and anti-obesity medication regimen (medication classes) and dose (equivalent dose if diabetes/anti-obesity-specific, or lipid-lowering medication has been changed within same medication class) for 3 months prior to enrollment.
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- Note: Changes ≤ 10% in total daily doses of insulin in the 3 months prior to enrollment are permitted.
- 7. Willing to follow study procedures as defined within the study protocol according to the judgement of the study physician.
- 8. Investigator believes that the participant has the cognitive capacity to provide informed consent, can successfully and safely use CGM, and is capable of adhering to the protocol and completing the study.
Who cannot join
- 1. Diagnosis of type 2 diabetes not on insulin or diagnosis of type 1 diabetes 2. Any surgical procedure for weight loss within the year prior to enrollment or plans for undergoing such bariatric surgery during the study.
- 3. Concomitant disease or condition that in the opinion of the investigator may compromise participant safety including but not limited to: solid organ transplant, cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits.
- 4. Use of medications known to exacerbate hyperglycemia (current or for more than 14 days in the past 3 months), including corticosteroids (oral and injectable) or certain psychotropics (antipsychotics, e.g., clozapine, olanzapine, risperidone, and quetiapine).
- 5. Known severe allergy to medical grade adhesives or a serious skin condition that precludes use of the CGM.
- 6. Currently pregnant, planning to become pregnant, or breastfeeding 7. End stage renal disease currently managed by dialysis or anticipating initiating dialysis during the next 6 months, OR eGFR <30.
- o Baseline blinded CGM data collection can be initiated prior to the lab result being available but lab result must be available prior to initiation to verify eligibility.
- 8. Anticipated acute uses of glucocorticoids (oral, injectable, or IV) that will affect glycemic control and impact HbA1c.
- 9. Current or planned use of hydroxyurea. 10. Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi Arabia: The "BENEFIT-KSA" Study
This study aims to understand how using real-time continuous glucose monitoring (RT-CGM) can help people with Type-2 diabetes on insulin in Saudi Arabia.
Read the detailed description
This study aims to understand how using real-time continuous glucose monitoring (RT-CGM) can help people with type 2 diabetes (T2DM) on insulin in Saudi Arabia better manage their blood sugar levels. Diabetes is a growing health problem in the country, affecting nearly 1 in 4 adults over 30. Many people struggle with managing their condition, leading to serious health complications and rising healthcare costs. This study will recruit adults with T2DM who are using either basal insulin (one or two daily basal injections) or are on intensive insulin insulin therapy (IIT-multiple daily injections).
Each participant will wear a RT-CGM device for 24 weeks, with an optional 30-day extension where participants will wear a blinded CGM to observe what happens when RT-CGM is stopped in this population. The CGM device tracks blood sugar levels continuously, helping both patients and doctors see patterns and make better treatment decisions. The main purpose of the study is to see if RT-CGM use helps lower HbA1c (a key marker of long-term blood sugar control) after 12 weeks. The study will also look at other outcomes, such as: Changes in HbA1c after 24 weeks; reduction in low blood sugar episodes; improvements in lifestyle habits like diet and exercise; changes in medication; effects on heart health and healthcare usage; and patient-reported experiences and satisfaction.
The study is designed to be safe, with risks similar to regular diabetes care. The information gained could help improve diabetes treatment in Saudi Arabia and support updates to local clinical guidelines for this patient population. The researchers believe that CGM can reduce HbA1c levels, empower patients to improve blood sugar control and reducing complications for people living with type 2 diabetes.
- Conditions
- Type 2 Diabetes on Insulin
- Being tested
- Real-Time Continuous Glucose Monitoring
- Keywords
- diabetes, insulin, type-2
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Continuous Glucose MonitoringDevice
real time continuous glucose monitoring utilizing a CGM
| Study group | Role | What they receive |
|---|---|---|
| real-time continuous glucose monitoring (RT-CGM) | Experimental | 24 weeks of real-time continuous glucose monitoring (RT-CGM) Receives: Device: Real-Time Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c from baseline to week 12
Measured: 12 weeks
Secondary outcomes (1)
Change in HbA1c and CGM derived metrics
Change in HbA1c from baseline to week 24
Measured: Measurement at 12 weeks & 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start24 Nov 2025
- Primary completion2 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes on InsulinStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm trial with 24 weeks of CGM wear followed by an optional 30-day CGM extension phase.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603284
- Sponsor's protocol ID
- PTL-1000518
- Acronym
- BENEFIT-KSA
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi Arabia: The "BENEFIT-KSA" Study
- ClinicalTrials.gov ID
- NCT07603284
- Acronym / sponsor ID
- BENEFIT-KSA / PTL-1000518
- Conditions
- Type 2 Diabetes on Insulin
- Keywords
- diabetes, insulin, type-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2026 (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 understand how using real-time continuous glucose monitoring (RT-CGM) can help people with Type-2 diabetes on insulin in Saudi Arabia.
Detailed description
This study aims to understand how using real-time continuous glucose monitoring (RT-CGM) can help people with type 2 diabetes (T2DM) on insulin in Saudi Arabia better manage their blood sugar levels. Diabetes is a growing health problem in the country, affecting nearly 1 in 4 adults over 30. Many people struggle with managing their condition, leading to serious health complications and rising healthcare costs. This study will recruit adults with T2DM who are using either basal insulin (one or two daily basal injections) or are on intensive insulin insulin therapy (IIT-multiple daily injections).
Each participant will wear a RT-CGM device for 24 weeks, with an optional 30-day extension where participants will wear a blinded CGM to observe what happens when RT-CGM is stopped in this population. The CGM device tracks blood sugar levels continuously, helping both patients and doctors see patterns and make better treatment decisions. The main purpose of the study is to see if RT-CGM use helps lower HbA1c (a key marker of long-term blood sugar control) after 12 weeks. The study will also look at other outcomes, such as: Changes in HbA1c after 24 weeks; reduction in low blood sugar episodes; improvements in lifestyle habits like diet and exercise; changes in medication; effects on heart health and healthcare usage; and patient-reported experiences and satisfaction.
The study is designed to be safe, with risks similar to regular diabetes care. The information gained could help improve diabetes treatment in Saudi Arabia and support updates to local clinical guidelines for this patient population. The researchers believe that CGM can reduce HbA1c levels, empower patients to improve blood sugar control and reducing complications for people living with type 2 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm trial with 24 weeks of CGM wear followed by an optional 30-day CGM extension phase.
| Arm | Type | Receives |
|---|---|---|
| real-time continuous glucose monitoring (RT-CGM) | Experimental | Device: Real-Time Continuous Glucose Monitoring24 weeks of real-time continuous glucose monitoring (RT-CGM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age of at least 18 years at time of screening. 2. Type 2 diabetes and on either intensive insulin therapy (IIT) or basal insulin therapy for ≥6 months prior to entry.
- IIT: Defined as basal insulin + ≥2 daily bolus injections of rapid acting insulin or ≥2 injections per day of premixed insulin (e.g. 70/30 or 50/50).
- Basal: Defined as ≤2 injections per day of basal insulin only and not planning to start rapid acting or premixed insulin in the next 6 months.
- 3. Screening HbA1c ≥8% at enrollment (by local lab at time of screening). 4. Assessment by clinician that participant is thought to be able and willing to wear, and motivated to engage with, a CGM device.
- 5. No personal real-time or intermittent scanned (Flash) CGM use, or use of a glucose biosensor 3 months prior to enrolment.
Key exclusion criteria (8 listed)
- 1. Diagnosis of type 2 diabetes not on insulin or diagnosis of type 1 diabetes 2. Any surgical procedure for weight loss within the year prior to enrollment or plans for undergoing such bariatric surgery during the study.
- 3. Concomitant disease or condition that in the opinion of the investigator may compromise participant safety including but not limited to: solid organ transplant, cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits.
- 4. Use of medications known to exacerbate hyperglycemia (current or for more than 14 days in the past 3 months), including corticosteroids (oral and injectable) or certain psychotropics (antipsychotics, e.g., clozapine, olanzapine, risperidone, and quetiapine).
- 5. Known severe allergy to medical grade adhesives or a serious skin condition that precludes use of the CGM.
- 6. Currently pregnant, planning to become pregnant, or breastfeeding 7. End stage renal disease currently managed by dialysis or anticipating initiating dialysis during the next 6 months, OR eGFR <30.
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 |
|---|---|---|
| Real-Time Continuous Glucose Monitoringreal time continuous glucose monitoring utilizing a CGM | Device | real-time continuous glucose monitoring (RT-CGM) |
Primary outcome
Change in HbA1c
Time frame: 12 weeks
Change in HbA1c from baseline to week 12
1 secondary outcome
Change in HbA1c and CGM derived metrics
Time frame: Measurement at 12 weeks & 24 weeks
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 22 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Real-Time Continuous Glucose Monitoring in people with Type 2 Diabetes on Insulin, run by DexCom, Inc. at 1 site in Saudi Arabia.
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 8 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 22 May 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 Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
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 22 May 2026.