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Active, not recruitingNCT07603284BENEFIT-KSAUpdated May 22, 2026

Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi Arabia

A Phase 4 interventional study of Real-Time Continuous Glucose Monitoring in Type 2 Diabetes on Insulin, sponsored by DexCom, Inc.. Active, not recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by DexCom, Inc. · Phase 4, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2025, registered May 2026).
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 2 Diabetes on Insulin

Keywords

  • diabetes
  • insulin
  • type-2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

- 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.

i. 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).

ii. 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.

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.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    real-time continuous glucose monitoring (RT-CGM)

    24 weeks of real-time continuous glucose monitoring (RT-CGM)

    Device: Real-Time Continuous Glucose Monitoring

Interventions

  • DeviceReal-Time Continuous Glucose Monitoring

    real time continuous glucose monitoring utilizing a CGM

06

What researchers measure

Primary outcomes

  1. Change in HbA1c

    Change in HbA1c from baseline to week 12

    Time frame: 12 weeks

Secondary outcomes

  1. Change in HbA1c and CGM derived metrics

    Change in HbA1c from baseline to week 24

    Time frame: Measurement at 12 weeks & 24 weeks

07

Study locations

1 site
  • King Fahad Medical City
    Riyadh, Saudi Arabia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07603284
Lead sponsor
DexCom, Inc.
Responsible party
Sponsor
First posted
May 22, 2026
Start date
Nov 24, 2025
Primary completion
Nov 2, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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