Can a smart glucose monitor help type 2 diabetes patients on insulin?
NCT ID NCT07603284
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a real-time continuous glucose monitor (CGM) can help 200 adults with type 2 diabetes who use insulin in Saudi Arabia. Participants wear a CGM device that tracks blood sugar levels continuously. The main goal is to see if it improves HbA1c, a measure of average blood sugar, over 12 weeks, with a follow-up at 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Real-time continuous glucose monitoring device
- What this could lead to
- If successful, this could show that continuous glucose monitoring helps people with type 2 diabetes on insulin achieve better blood sugar control, potentially reducing complications.
- What could go wrong
- This is a relatively small, single-country study (200 participants) focused on short-term outcomes (12-24 weeks). Results may not apply to all populations or prove long-term benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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King Fahad Medical City
Riyadh, Saudi Arabia