Type 1 DiabetesREVERSIBLENCT04876079
Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes
A study testing Test to induce a decline in plasma glucose, Dexcom G6 and Dex4 in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Test to induce a decline in plasma glucose, Dexcom G6 and Dex4
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 30 Jun 2023
- 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
- Males and females ≥ 18 years old
- Clinical diagnosis of type 1 diabetes for at least one year
- Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)
- A glycated hemoglobin A1c ≤ 10%
Who cannot join
- Clinically significant microvascular complications: nephropathy (eGFR < 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)
- Recent (< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
- Known significant cardiac rhythm abnormality based on investigator's judgement
- Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement
- Ongoing pregnancy or breastfeeding
- Severe hypoglycemia episode within 1 month of screening
- Known uncorrected hypokalemia within the past 3 months (potassium < 3.5 mmol/L)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy. In practice, only 32-50% of patients follow the current guidelines. In addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. With the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).
- Conditions
- Type 1 Diabetes
- Being tested
- Test to induce a decline in plasma glucose, Dexcom G6, Dex4, Insulin
- Keywords
- Hypoglycemia, Type 1 diabetes, Carbohydrates
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test to induce a decline in plasma glucoseOther
Participants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to bring plasma glucose to the glycemic threshold. Oral carbohydrates (16g) will be given when plasma glucose levels are at the target threshold. Sixty minutes after carbohydrates consumption, a standardized meal will be provided and participants will be discharged 90 minutes after the meal.
Dexcom G6Device
Participants will have to wear a Dexcom G6 during study interventions
Dex4Other
When the glycemic threshold is reach, participants will be given 16g of Dex4
InsulinDrug
A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.
| Study group | Role | What they receive |
|---|---|---|
| 16g of carbohydrates - Plasma glucose < 4.0 mmol/L | Active comparator | 16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines) Receives: Other: Test to induce a decline in plasma glucose; Device: Dexcom G6; Other: Dex4; Drug: Insulin |
| 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L | Active comparator | 16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L. Receives: Other: Test to induce a decline in plasma glucose; Device: Dexcom G6; Other: Dex4; Drug: Insulin |
| 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L | Active comparator | 16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L. Receives: Other: Test to induce a decline in plasma glucose; Device: Dexcom G6; Other: Dex4; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent of glucose levels < 4.0 mmol/L
Measured: 60 minutes after carbohydrates consumption
Secondary outcomes (27)
Plasma glucose levels at 5 minutes after carbohydrates consumption
Measured: 5 minutes after carbohydrates consumption
Plasma glucose levels at 10 minutes after carbohydrates consumption
Measured: 10 minutes after carbohydrates consumption
Plasma glucose levels at 15 minutes after carbohydrates consumption
Measured: 15 minutes after carbohydrates consumption
Plasma glucose levels at 20 minutes after carbohydrates consumption
Measured: 20 minutes after carbohydrates consumption
Plasma glucose levels at 30 minutes after carbohydrates consumption
Measured: 30 minutes after carbohydrates consumption
Plasma glucose levels at 45 minutes after carbohydrates consumption
Measured: 45 minutes after carbohydrates consumption
Plasma glucose levels at 60 minutes after carbohydrates consumption
Measured: 60 minutes after carbohydrates consumption
Lowest plasma glucose level eached after CHO consumption
Measured: 60 minutes after carbohydrates consumption
Time from CHO consumption to the lowest plasma glucose level reached
Measured: 60 minutes after carbohydrates consumption
Time from CHO consumption to plasma glucose < 3.5 mmol/L
Measured: 60 minutes after carbohydrates consumption
Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption
Measured: 60 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 10 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 15 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 20 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 25 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 30 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 35 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption
Only calculated for events with glucose level < 4.0 mmol/L
Measured: 10 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption
Only calculated for events with glucose level < 4.0 mmol/L
Measured: 15 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption
Only calculated for events with glucose level < 4.0 mmol/L
Measured: 20 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption
Only calculated for events with glucose level < 4.0 mmol/L
Measured: 25 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption
Only calculated for events with glucose level < 4.0 mmol/L
Measured: 30 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption
Only calculated for events with glucose level < 4.0 mmol/L
Measured: 35 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 20 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 40 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption
Only calculated for participants who will have glucose levels < 4.0 mmol/L
Measured: 60 minutes after carbohydrates consumption
Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption
Measured: 60 minutes after carbohydrates consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
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 Type 1 DiabetesStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876079
- Sponsor's protocol ID
- 2022-1119
- Acronym
- REVERSIBLE
- Status last verified
- Mar 2026
- First submitted
- 3 May 2021
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng R, Taleb N, Wu Z, Bouchard D, Parent V, Lalanne-Mistrih ML, Boudreau V, Messier V, Lacombe MJ, Grou C, Brazeau AS, Rabasa-Lhoret R. Managing Impending Nonsevere Hypoglycemia With Oral Carbohydrates in Type 1 Diabetes: The REVERSIBLE Trial. Diabetes Care. 2024 Mar 1;47(3):476-482. doi: 10.2337/dc23-1328.
PubMed 38194601
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold
- ClinicalTrials.gov ID
- NCT04876079
- Acronym / sponsor ID
- REVERSIBLE / 2022-1119
- Conditions
- Type 1 Diabetes
- Keywords
- Hypoglycemia, Type 1 diabetes, Carbohydrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 May 2021 (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.
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy. In practice, only 32-50% of patients follow the current guidelines. In addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. With the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 16g of carbohydrates - Plasma glucose < 4.0 mmol/L | Active comparator | Other: Test to induce a decline in plasma glucose, Device: Dexcom G6, Other: Dex4, Drug: Insulin16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines) |
| 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L | Active comparator | Other: Test to induce a decline in plasma glucose, Device: Dexcom G6, Other: Dex4, Drug: Insulin16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L. |
| 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L | Active comparator | Other: Test to induce a decline in plasma glucose, Device: Dexcom G6, Other: Dex4, Drug: Insulin16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥ 18 years old
- Clinical diagnosis of type 1 diabetes for at least one year
- Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)
- A glycated hemoglobin A1c ≤ 10%
Key exclusion criteria (7 listed)
- Clinically significant microvascular complications: nephropathy (eGFR < 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)
- Recent (< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
- Known significant cardiac rhythm abnormality based on investigator's judgement
- Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement
- Ongoing pregnancy or breastfeeding
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 |
|---|---|---|
| Test to induce a decline in plasma glucoseParticipants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to bring plasma glucose to the glycemic threshold. Oral carbohydrates (16g) will be given when plasma glucose levels are at the target threshold. Sixty minutes after carbohydrates consumption, a standardized meal will be provided and participants will be discharged 90 minutes after the meal. | Other | 16g of carbohydrates - Plasma glucose < 4.0 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L |
| Dexcom G6Participants will have to wear a Dexcom G6 during study interventions | Device | 16g of carbohydrates - Plasma glucose < 4.0 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L |
| Dex4When the glycemic threshold is reach, participants will be given 16g of Dex4 | Other | 16g of carbohydrates - Plasma glucose < 4.0 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L |
| InsulinA subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold. | Drug | 16g of carbohydrates - Plasma glucose < 4.0 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L, 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L |
Primary outcome
Time spent of glucose levels < 4.0 mmol/L
Time frame: 60 minutes after carbohydrates consumption
27 secondary outcomes
Plasma glucose levels at 5 minutes after carbohydrates consumption
Time frame: 5 minutes after carbohydrates consumption
Plasma glucose levels at 10 minutes after carbohydrates consumption
Time frame: 10 minutes after carbohydrates consumption
Plasma glucose levels at 15 minutes after carbohydrates consumption
Time frame: 15 minutes after carbohydrates consumption
Plasma glucose levels at 20 minutes after carbohydrates consumption
Time frame: 20 minutes after carbohydrates consumption
Plasma glucose levels at 30 minutes after carbohydrates consumption
Time frame: 30 minutes after carbohydrates consumption
Plasma glucose levels at 45 minutes after carbohydrates consumption
Time frame: 45 minutes after carbohydrates consumption
Plasma glucose levels at 60 minutes after carbohydrates consumption
Time frame: 60 minutes after carbohydrates consumption
Lowest plasma glucose level eached after CHO consumption
Time frame: 60 minutes after carbohydrates consumption
Time from CHO consumption to the lowest plasma glucose level reached
Time frame: 60 minutes after carbohydrates consumption
Time from CHO consumption to plasma glucose < 3.5 mmol/L
Time frame: 60 minutes after carbohydrates consumption
Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption
Time frame: 60 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption
Time frame: 10 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption
Time frame: 15 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption
Time frame: 20 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption
Time frame: 25 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption
Time frame: 30 minutes after carbohydrates consumption
Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption
Time frame: 35 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption
Time frame: 10 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption
Time frame: 15 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption
Time frame: 20 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption
Time frame: 25 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption
Time frame: 30 minutes after carbohydrates consumption
Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption
Time frame: 35 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption
Time frame: 20 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption
Time frame: 40 minutes after carbohydrates consumption
Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption
Time frame: 60 minutes after carbohydrates consumption
Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption
Time frame: 60 minutes after carbohydrates consumption
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 5 Mar 2026.
- Derived from this study: PubMed 38194601Cheng R, Taleb N, Wu Z, Bouchard D, Parent V, Lalanne-Mistrih ML, Boudreau V, Messier V, Lacombe MJ, Grou C, Brazeau AS, Rabasa-Lhoret R. Managing Impending Nonsevere Hypoglycemia With Oral Carbohydrates in Type 1 Diabetes: The REVERSIBLE Trial. Diabetes Care. 2024 Mar 1;47(3):476-482. doi: 10.2337/dc23-1328.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test to induce a decline in plasma glucose, Dexcom G6 and Dex4 in people with Type 1 Diabetes, 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 4 inclusion and 7 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 5 Mar 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?
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?
Time spent of glucose levels < 4.0 mmol/L (time frame: 60 minutes after carbohydrates consumption). 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 NCT04876079, 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 5 Mar 2026.