Type 1 Diabetes (T1D)NOMADNCT07758647
NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems
A study testing Open-Source Automated Insulin Delivery (OS-AID) and Commercial Automated Insulin Delivery (C-AID) in people with Type 1 Diabetes (T1D), run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
Automated insulin delivery (AID) systems are the current gold standard for the management of type 1 diabetes (T1D), improving glycemic control, reducing hypoglycemia, and decreasing treatment burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Open-Source Automated Insulin Delivery (OS-AID) and Commercial Automated Insulin Delivery (C-AID)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 31 Dec 2029
- Phase
- Interventional
- 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
- Males and females ≥ 18 years old currently residing in Canada or the United States of America (USA)
- Having a clinical diagnosis of T1D for at least one year (based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- Having been on OS-AID therapy for at least 2 weeks and using a Dexcom G6 or G7 CGM.
- If using an ultra-rapid acting insulin, be willing to switch to a rapid-acting insulin, as the former are not recommended in the C-AID systems used in the study (due to the risk of cannula or pod blockage).
- Accepting that personal pump setting parameters will be collected by the research team. This access will be limited to the study period.
Who cannot join
- Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500)
- Participant-reported clinically significant nephropathy (eGFR < 25 ml/min/1.73m2, planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator
- Recent (<3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
- Anticipated therapeutic change (including change of CGM sensor [other than Dexcom sensors] or AID system type, new antidiabetic drug initiation) between admission and end of the study
- % of time spent out of automated mode exceeding 10% in last month's trial start
- Anticipated need to use hydroxyurea during the study period (as it can interfere with CGM readings)
Show all 18Show fewer
- Pregnancy (ongoing or current attempt to become pregnant)
- Breastfeeding
- Plan to go abroad in a foreign country during the study period
- Severe hypoglycemic episode within one month of screening
- Severe hyperglycemic episode (including DKA) requiring hospitalization in the last 3 months
- Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)
- Current use of SGLT-2 inhibitors or GLP1 agonists or other antidiabetic agents (Metformin, DPP-4 inhibitors) unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed (for iSGLT2 treatment).
- Known or suspected allergies to study products (e.g., Dexcom adhesive)
- Other serious medical illnesses likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator
- Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change)
- Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI)
- In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, H2H 1Y8
Joséphine Molveau, PhD, (514) 987-3318, josephine.molveau@ircm.qc.ca
Rémi Rabasa-Lhoret, M.D. Ph.D
About this study
Automated insulin delivery (AID) systems are the current gold standard for the management of type 1 diabetes (T1D), improving glycemic control, reducing hypoglycemia, and decreasing treatment burden. Although both commercial AID (C-AID) and open-source AID (OS-AID) systems have demonstrated significant clinical benefits, direct randomized comparisons between these systems remain scarce. Moreover, an important limitation of currently available AID systems is their reliance on user-initiated meal announcements and carbohydrate counting, which remain major contributors to postprandial dysglycemia and treatment burden. While emerging evidence suggests that AID systems may partially compensate for missed meal announcements, their comparative performance under these challenging real-world conditions is unknown.
The NOMAD study is an international, multicenter, open-label, randomized, non-inferiority crossover trial designed to compare an open-source AID system with commercially available AID systems (including Tandem Control-IQ and Omnipod 5) in adults with type 1 diabetes currently using an open-source AID system. The study specifically evaluates glycemic outcomes following standardized unannounced meal challenges performed under free-living conditions.
Read more
A total of 33 participants will be enrolled and complete two 4-week intervention periods, each consisting of a 2-week run-in phase followed by a 2-week data collection phase, with crossover between treatment arms. Participants will continue using their own Dexcom G6 or Dexcom G7 continuous glucose monitoring system throughout the study.
The primary outcome is the percentage of time spent in the target glucose range (3.9-10.0 mmol/L) during the 4 hours following standardized unannounced meal challenges. Secondary outcomes include additional CGM metrics (time above and below range, glucose variability, mean glucose, and GMI), insulin delivery characteristics, and patient-reported outcomes evaluating treatment satisfaction, usability, and diabetes-related burden.
Read the detailed description
AID systems have become the preferred treatment for T1D, improving glycemic control, reducing hypoglycemia, and decreasing treatment burden compared with conventional insulin therapy. Both C-AID and OS-AID systems have demonstrated substantial clinical benefits, including increased time in range and improved patient-reported outcomes. However, despite their growing adoption, few randomized controlled trials have directly compared these systems under standardized conditions.
One of the major remaining challenges for current AID systems is the management of meals. Most commercially available systems are hybrid closed-loop systems that require users to announce meals and estimate carbohydrate intake before eating. Inaccurate carbohydrate estimation, delayed boluses, or missed meal announcements are common in daily life and contribute substantially to postprandial hyperglycemia and overall treatment burden. Although AID algorithms can partially compensate for these situations through automated insulin adjustments, their effectiveness varies between systems and has not been directly compared under real-world conditions.
This study aims to compare the performance of open-source and commercial AID systems during standardized unannounced meal challenges performed under free-living conditions. Adults with T1D who are experienced users of an OS-AID system will participate in a randomized, open-label, crossover trial in which they will use both their usual OS-AID system and a commercially available AID system. Throughout the study, participants will use the same Dexcom continuous glucose monitoring system to ensure consistent glucose assessment across study periods.
The primary objective is to determine whether OS-AID is non-inferior to commercial AID for maintaining postprandial glucose control following unannounced meals, as measured by the percentage of time spent in the target glucose range during the 4 hours after meal initiation. Secondary objectives include comparing overall glycemic outcomes, glucose variability, insulin delivery characteristics, and patient-reported outcomes related to treatment satisfaction, diabetes burden, and usability. The study will also explore differences in insulin dosing behavior, including user-initiated boluses, between the two AID approaches.
By evaluating glycemic performance in a common real-world scenario where meal announcements are omitted, this study will provide evidence regarding the comparative effectiveness, safety, and user experience of open-source and commercial AID systems. The findings are expected to inform clinical decision-making, support individualized selection of AID systems, and contribute to the development of future automated insulin delivery technologies that further reduce the burden of diabetes self-management.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Open-Source Automated Insulin Delivery (OS-AID), Commercial Automated Insulin Delivery (C-AID)
- Keywords
- Automated Insulin Delivery Systems
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-Source Automated Insulin Delivery (OS-AID)Device
Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, in combination with a compatible insulin pump and Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM). These systems use open-source algorithms to automatically adjust insulin delivery based on real-time CGM data through adaptive basal insulin modulation and, depending on the platform, automated correction boluses. Participants will continue using their established OS-AID settings throughout the intervention period without software updates and will be asked to perform two unannounced meal-challenges.
Commercial Automated Insulin Delivery (C-AID)Device
Participants will use a commercially available hybrid closed-loop AID system compatible with Dexcom G6 or Dexcom G7 CGM. Depending on study allocation and participants' usual device, the commercial system will include Tandem t X2 with Control-IQ technology or Omnipod 5. Participants not already using a compatible commercial AID system will receive study equipment and standardized training before initiating the intervention. Commercial AID systems automatically adjust insulin delivery based on continuous glucose measurements using manufacturer-specific algorithms while continuing to recommend user-initiated meal announcements and boluses for optimal performance.
| Study group | Role | What they receive |
|---|---|---|
| OS-AID | Active comparator | Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, together with their usual compatible insulin pump and a Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM) system. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period. Receives: Device: Open-Source Automated Insulin Delivery (OS-AID) |
| Commercial-AID | Active comparator | Participants will use a C-AID system compatible with Dexcom CGM, including Tandem t X2 with Control-IQ or Omnipod 5, depending on their device and study allocation. Participants will receive study-provided equipment and training. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period. Receives: Device: Commercial Automated Insulin Delivery (C-AID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time in target glucose range during the 4 hours following unannounced meal challenges
Percentage of time with sensor glucose between 3.9 and 10.0 mmol/L (70-180 mg/dL) during the 4 hours following standardized unannounced meal challenges, measured using continuous glucose monitoring (CGM). Data will be analyzed at the meal level using all meal challenges completed during each intervention period.
Measured: During the final 2 weeks of each 4-week intervention period (following the run-in phase).
Secondary outcomes (4)
Time in tight range
Percentage of time with sensor glucose between 3.9 and 7.8 mmol/L (70-140 mg/dL), measured by CGM.
Measured: Final 2 weeks of each intervention period.
Time Above Range (>10 mmol/L)
Percentage of time with sensor glucose >10.0 mmol/L (>180 mg/dL), measured by CGM.
Measured: Final 2 weeks of each intervention period.
Time Above Range (>13.9 mmol/L)
Percentage of time with sensor glucose >13.9 mmol/L (>250 mg/dL), measured by CGM.
Measured: Final 2 weeks of each intervention period.
Mean Glucose
Mean sensor glucose concentration (mmol/L) measured using CGM.
Measured: Final 2 weeks of each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of Alberta
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, M.D. Ph.D, Principal investigator, IRCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758647
- Sponsor's protocol ID
- NOMAD
- Acronym
- NOMAD
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and regulatory constraints, individual participant data generated in this study will not be made available to other researchers. Study results will be made publicly available through peer-reviewed publications and sharing with people living with T1D and caregivers: webinar, Better website, etc.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems
- ClinicalTrials.gov ID
- NCT07758647
- Acronym / sponsor ID
- NOMAD / NOMAD
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Automated Insulin Delivery Systems
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Stanford University, University of Alberta
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Aug 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.
Automated insulin delivery (AID) systems are the current gold standard for the management of type 1 diabetes (T1D), improving glycemic control, reducing hypoglycemia, and decreasing treatment burden. Although both commercial AID (C-AID) and open-source AID (OS-AID) systems have demonstrated significant clinical benefits, direct randomized comparisons between these systems remain scarce. Moreover, an important limitation of currently available AID systems is their reliance on user-initiated meal announcements and carbohydrate counting, which remain major contributors to postprandial dysglycemia and treatment burden. While emerging evidence suggests that AID systems may partially compensate for missed meal announcements, their comparative performance under these challenging real-world conditions is unknown.
The NOMAD study is an international, multicenter, open-label, randomized, non-inferiority crossover trial designed to compare an open-source AID system with commercially available AID systems (including Tandem Control-IQ and Omnipod 5) in adults with type 1 diabetes currently using an open-source AID system. The study specifically evaluates glycemic outcomes following standardized unannounced meal challenges performed under free-living conditions.
A total of 33 participants will be enrolled and complete two 4-week intervention periods, each consisting of a 2-week run-in phase followed by a 2-week data collection phase, with crossover between treatment arms. Participants will continue using their own Dexcom G6 or Dexcom G7 continuous glucose monitoring system throughout the study.
The primary outcome is the percentage of time spent in the target glucose range (3.9-10.0 mmol/L) during the 4 hours following standardized unannounced meal challenges. Secondary outcomes include additional CGM metrics (time above and below range, glucose variability, mean glucose, and GMI), insulin delivery characteristics, and patient-reported outcomes evaluating treatment satisfaction, usability, and diabetes-related burden.
Detailed description
AID systems have become the preferred treatment for T1D, improving glycemic control, reducing hypoglycemia, and decreasing treatment burden compared with conventional insulin therapy. Both C-AID and OS-AID systems have demonstrated substantial clinical benefits, including increased time in range and improved patient-reported outcomes. However, despite their growing adoption, few randomized controlled trials have directly compared these systems under standardized conditions.
One of the major remaining challenges for current AID systems is the management of meals. Most commercially available systems are hybrid closed-loop systems that require users to announce meals and estimate carbohydrate intake before eating. Inaccurate carbohydrate estimation, delayed boluses, or missed meal announcements are common in daily life and contribute substantially to postprandial hyperglycemia and overall treatment burden. Although AID algorithms can partially compensate for these situations through automated insulin adjustments, their effectiveness varies between systems and has not been directly compared under real-world conditions.
This study aims to compare the performance of open-source and commercial AID systems during standardized unannounced meal challenges performed under free-living conditions. Adults with T1D who are experienced users of an OS-AID system will participate in a randomized, open-label, crossover trial in which they will use both their usual OS-AID system and a commercially available AID system. Throughout the study, participants will use the same Dexcom continuous glucose monitoring system to ensure consistent glucose assessment across study periods.
The primary objective is to determine whether OS-AID is non-inferior to commercial AID for maintaining postprandial glucose control following unannounced meals, as measured by the percentage of time spent in the target glucose range during the 4 hours after meal initiation. Secondary objectives include comparing overall glycemic outcomes, glucose variability, insulin delivery characteristics, and patient-reported outcomes related to treatment satisfaction, diabetes burden, and usability. The study will also explore differences in insulin dosing behavior, including user-initiated boluses, between the two AID approaches.
By evaluating glycemic performance in a common real-world scenario where meal announcements are omitted, this study will provide evidence regarding the comparative effectiveness, safety, and user experience of open-source and commercial AID systems. The findings are expected to inform clinical decision-making, support individualized selection of AID systems, and contribute to the development of future automated insulin delivery technologies that further reduce the burden of diabetes self-management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OS-AID | Active comparator | Device: Open-Source Automated Insulin Delivery (OS-AID)Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, together with their usual compatible insulin pump and a Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM) system. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period. |
| Commercial-AID | Active comparator | Device: Commercial Automated Insulin Delivery (C-AID)Participants will use a C-AID system compatible with Dexcom CGM, including Tandem t X2 with Control-IQ or Omnipod 5, depending on their device and study allocation. Participants will receive study-provided equipment and training. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 18 years old currently residing in Canada or the United States of America (USA)
- Having a clinical diagnosis of T1D for at least one year (based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- Having been on OS-AID therapy for at least 2 weeks and using a Dexcom G6 or G7 CGM.
- If using an ultra-rapid acting insulin, be willing to switch to a rapid-acting insulin, as the former are not recommended in the C-AID systems used in the study (due to the risk of cannula or pod blockage).
- Accepting that personal pump setting parameters will be collected by the research team. This access will be limited to the study period.
Key exclusion criteria (18 listed)
- Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500)
- Participant-reported clinically significant nephropathy (eGFR < 25 ml/min/1.73m2, planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator
- Recent (<3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
- Anticipated therapeutic change (including change of CGM sensor [other than Dexcom sensors] or AID system type, new antidiabetic drug initiation) between admission and end of the study
- % of time spent out of automated mode exceeding 10% in last month's trial start
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 |
|---|---|---|
| Open-Source Automated Insulin Delivery (OS-AID)Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, in combination with a compatible insulin pump and Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM). These systems use open-source algorithms to automatically adjust insulin delivery based on real-time CGM data through adaptive basal insulin modulation and, depending on the platform, automated correction boluses. Participants will continue using their established OS-AID settings throughout the intervention period without software updates and will be asked to perform two unannounced meal-challenges. | Device | OS-AID |
| Commercial Automated Insulin Delivery (C-AID)Participants will use a commercially available hybrid closed-loop AID system compatible with Dexcom G6 or Dexcom G7 CGM. Depending on study allocation and participants' usual device, the commercial system will include Tandem t X2 with Control-IQ technology or Omnipod 5. Participants not already using a compatible commercial AID system will receive study equipment and standardized training before initiating the intervention. Commercial AID systems automatically adjust insulin delivery based on continuous glucose measurements using manufacturer-specific algorithms while continuing to recommend user-initiated meal announcements and boluses for optimal performance. | Device | Commercial-AID |
Primary outcome
Percentage of time in target glucose range during the 4 hours following unannounced meal challenges
Time frame: During the final 2 weeks of each 4-week intervention period (following the run-in phase).
Percentage of time with sensor glucose between 3.9 and 10.0 mmol/L (70-180 mg/dL) during the 4 hours following standardized unannounced meal challenges, measured using continuous glucose monitoring (CGM). Data will be analyzed at the meal level using all meal challenges completed during each intervention period.
4 secondary outcomes
Time in tight range
Time frame: Final 2 weeks of each intervention period.
Time Above Range (>10 mmol/L)
Time frame: Final 2 weeks of each intervention period.
Time Above Range (>13.9 mmol/L)
Time frame: Final 2 weeks of each intervention period.
Mean Glucose
Time frame: Final 2 weeks of each intervention period
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 11 Aug 2026.
- Individual participant dataSharing planned: No. Due to ethical and regulatory constraints, individual participant data generated in this study will not be made available to other researchers. Study results will be made publicly available through peer-reviewed publications and sharing with people living with T1D and caregivers: webinar, Better website, etc.
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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.
Rémi Rabasa-Lhoret, M.D. Ph.D principal investigator
IRCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open-Source Automated Insulin Delivery (OS-AID) and Commercial Automated Insulin Delivery (C-AID) in people with Type 1 Diabetes (T1D), run by Institut de Recherches Cliniques de Montreal 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 5 inclusion and 18 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: opening soon, as of the sponsor's last update on 11 Aug 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 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?
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?
Contact Joséphine Molveau, Ph.D ((514) 987-3318, josephine.molveau@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time in target glucose range during the 4 hours following unannounced meal challenges (time frame: During the final 2 weeks of each 4-week intervention period (following the run-in phase).). 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 11 Aug 2026.