Type 1 Diabetes (T1D)AFS_T1DNCT06315725
Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients With Type 1 Diabetes (T1D)
An observational study of Type 1 Diabetes (T1D) and Healthy Subjects, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes (T1D), Healthy Subjects
- What is being tested?
- Sweet taste perception with/without sweet taste blockade
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 12 Nov 2024to 22 Sep 2026
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: For the pilot study, 10 healthy participants will be recruited. For the main study, 15 potential participants with T1D will be recruited.
Who may be able to join
- Participants with a diagnosis of T1D
- HbA1C ≤ 8 %
- Insulin pump therapy
- Adults of any gender or biological sex aged 18-45 years old,
- Body Mass Index (BMI) between 18.5-29.9 kg/m,
- Non-smokers,
- English or French speaker. ●. Who can consume chicken and fish
Who cannot join
- A major medical diagnosis that could potentially influence metabolic dysfunction
- A major medical diagnosis other than T1D,
- Alcohol or substance use disorder,
- Eating disorder or history of malabsorptive syndrome,
- Inflammatory bowel disease,
- Self-reported impairment in taste or smell,
Show all 11Show fewer
- A known taste or smell dysfunction (e.g., anosmia),
- Active pregnancy and/or lactation,
- Food allergies or intolerances,
- Dislike of the test beverages,
- History of bariatric surgery at any point in the past ●. Regular consumer of Gymnema sylvestre
Trial locations and contacts
1 site in 1 country.
Canada1 site
Center for Innovative Medicine, The Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
About this study
Official title: A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients With Type 1 Diabetes
The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time.
Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level.
Read more
To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study.
Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker.
- Conditions
- Type 1 Diabetes (T1D), Healthy Subjects
- Being tested
- Sweet taste perception with/without sweet taste blockade
- Keywords
- Type 1 Diabetes, Artificial Pancreas, Artificial Sweeteners, Non-Nutritive Sweeteners, Cross-Over, Taste Perception, Indirect Calorimetry, Insulin, Glucose Metabolism
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweet taste perception with/without sweet taste blockadeOther
In our study, we will use our four different novel flavored beverages, with and without a sweet taste blockade.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals
our aim is to test whether the impact of consuming NNS with carbohydrates on glucose metabolism is related to oral or post-oral sweet taste receptor signaling.
Measured: from enrollment to the end of treatment at 4 weeks
Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption.
Consuming NNS alongside carbohydrates affects glucose metabolism differently compared to carbohydrates alone in participants with type 1 diabetes (T1D) using an artificial pancreas (AP) system for exogenous insulin production
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption
To test whether the co-ingestion of the NNS with carbohydrate can result in changes in post-ingestion metabolism, we plan to employ indirect calorimetry (IC) to evaluate resting energy expenditure (REE) before and after flavoured beverages consumption.
Measured: from enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start12 Nov 2024
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
Why it stopped: The study was terminated due to recruitment difficulties. Only three participants enrolled within two years due to specific insulin pump requirements. Recruitment was therefore discontinued before the planned sample size was reached.
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.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Other
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Small, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315725
- Sponsor's protocol ID
- 2024-10504
- Acronym
- AFS_T1D
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2024
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Study to Investigate the Effect of the Non-Nutritive Sweetener Sucralose on Glucose Metabolism in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06315725
- Acronym / sponsor ID
- AFS_T1D / 2024-10504
- Conditions
- Type 1 Diabetes (T1D), Healthy Subjects
- Keywords
- Type 1 Diabetes, Artificial Pancreas, Artificial Sweeteners, Non-Nutritive Sweeteners, Cross-Over, Taste Perception, Indirect Calorimetry, Insulin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to recruitment difficulties. Only three participants enrolled within two years due to specific insulin pump requirements. Recruitment was therefore discontinued before the planned sample size was reached.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 22 Sep 2026 (actual)
- Study completion
- 22 Sep 2026 (actual)
- First posted
- 18 Mar 2024 (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.
The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time.
Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level.
To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study.
Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker.
Study design
- Observational model
- Case crossover
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For the pilot study, 10 healthy participants will be recruited. For the main study, 15 potential participants with T1D will be recruited.
Key inclusion criteria (7 listed)
- Participants with a diagnosis of T1D
- HbA1C ≤ 8 %
- Insulin pump therapy
- Adults of any gender or biological sex aged 18-45 years old,
- Body Mass Index (BMI) between 18.5-29.9 kg/m,
Key exclusion criteria (11 listed)
- A major medical diagnosis that could potentially influence metabolic dysfunction
- A major medical diagnosis other than T1D,
- Alcohol or substance use disorder,
- Eating disorder or history of malabsorptive syndrome,
- Inflammatory bowel disease,
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 |
|---|---|---|
| Sweet taste perception with/without sweet taste blockadeIn our study, we will use our four different novel flavored beverages, with and without a sweet taste blockade. | Other | – |
Primary outcome
Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals
Time frame: from enrollment to the end of treatment at 4 weeks
our aim is to test whether the impact of consuming NNS with carbohydrates on glucose metabolism is related to oral or post-oral sweet taste receptor signaling.
Mean plasma glucose, basal and bolus insulin changes in individuals with T1D on AP following beverage consumption.
Time frame: From enrollment to the end of treatment at 4 weeks
Consuming NNS alongside carbohydrates affects glucose metabolism differently compared to carbohydrates alone in participants with type 1 diabetes (T1D) using an artificial pancreas (AP) system for exogenous insulin production
1 secondary outcome
Resting Energy Expenditure (REE) and nutrient partitioning changes in individuals with T1D on AP following beverage consumptionT1D on AP following beverage consumption
Time frame: from enrollment to the end of treatment at 4 weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to recruitment difficulties. Only three participants enrolled within two years due to specific insulin pump requirements. Recruitment was therefore discontinued before the planned sample size was reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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?
An observational study of Type 1 Diabetes (T1D) and Healthy Subjects, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 6 Oct 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 was stopped early (reason given: The study was terminated due to recruitment difficulties. Only three participants enrolled within two years due to specific insulin pump requirements. Recruitment was therefore discontinued before the planned sample size was reached.). Results are not available in the source record.
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?
Effectiveness and optimal time course of sweet test blockade on sweet taste perception in healthy individuals (time frame: from enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. 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 6 Oct 2026.