Type 1 DiabetesNCT04385888
Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes
A study testing Low-calorie sweetener restriction in people with Type 1 Diabetes, run by Allison Sylvetsky (Meni) at 1 site in United States.
Trial summary
This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Low-calorie sweetener restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child 6-12 years old
- Report consumption of ≥ 12 oz. beverages with sucralose (+/- ace-K) or aspartame+ace-K per day
- Child has had a diagnosis of T1D for at least one year
- Parent/guardian has reliable phone and internet access
- Parent/guardian and child both speak English
- Child is enrolled in the Diabetes Program at Children's National Hospital
Who cannot join
- Child under 6 years of age
- Child older than 12 years of age
- Child consumes foods with low-calorie sweeteners more than 3 times per week
- Child consumes condiments with low-calorie sweeteners more than 3 times per week
- Child has poorly managed chronic disease other than T1D or is taking medications other than insulin
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).
Read the detailed description
Eligible participants will be scheduled for a baseline visit. During the week prior, they will be instructed to continue usual dietary habits and complete an online photo-assisted food record, with parental assistance. At the baseline visit, height and weight will be measured, a spot urine sample will be collected, and a blood draw will be performed. Participants will have their CGM data for the past two weeks downloaded. In a subset of participants, an abdominal MRI will also be performed.
Subjects will then be randomized to either: 1) low-calorie sweetener (LCS) restriction or 2) continuation of usual LCS intake (control). All participants (both groups) and their parent will undergo a brief, 20-minute orientation where the PI and study dietitian will provide an introduction to the study, instructions on completing food records, education on CGM. Those in the intervention group will be given sample replacement beverages and a brochure on avoiding LCS to take home which will include a list of specific foods and beverages containing LCS to avoid during the study. Participants in the control group will be counseled on healthy eating as those in the intervention group (in accordance with standard dietary guidance for T1D management), with the exception of information and resources for avoiding LCS.
In both groups, text messages will be sent to parents 3X/week with reminders that their child should avoid LCS or continue usual intake, per randomization. Adherence will be monitored through collection of spot-urine samples for measurement of sucralose and ace-K concentrations. daily text message beverage logs completed by the parent, and photo-assisted food records with parent assistance in Weeks 0, 1, 6, and 12. During Week 6, participants and their parent will attend a mid-intervention telemedicine booster visit, during which the PI and/or study RA will reinforce the intervention and remind participants to mail back a spot urine sample using materials provided by the study team at baseline. Participants will be reminded of the study instructions, including the importance of inserting the DEXCOM G6 sensor (provided by study team) at the beginning of Week 11.
At the end of Week 12, participants and their parent will return for follow-up. Participants will have their CGM data downloaded using DEXCOM Clarity™ software. Height and weight will be measured and a second blood draw performed. Those who had an MRI at the baseline visit (n=30) will undergo a second abdominal MRI. Those randomized to the intervention will be purposefully sampled and asked to complete a ~20 minute qualitative interview and ~5 minute satisfaction survey, together with their parent, about their study experience and the challenges of LCSB restriction.
- Conditions
- Type 1 Diabetes
- Being tested
- Low-calorie sweetener restriction
- 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.
Low-calorie sweetener restrictionBehavioural
Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water
| Study group | Role | What they receive |
|---|---|---|
| Low-calorie sweetener restriction | Experimental | Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. Receives: Behavioral: Low-calorie sweetener restriction |
| Usual consumption/control | No intervention | Participants will continue low-calorie sweetener consumption, as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Variability
Change in Time in Range (TIR)
Measured: Baseline vs Weeks 11-12
Secondary outcomes (2)
Visceral Adiposity
Change in visceral fat area will be assessed using DXA. Due to COVID-19, very few participants were able to have visceral fat measured pre and post intervention.
Measured: Baseline vs. Week 12
Change in Inflammatory Cytokines (TNF-alpha)
We will collect a blood sample to measure TNF-alpha and calculate the change from baseline.
Measured: Baseline vs Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start28 Oct 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allison Sylvetsky (Meni)
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute
- Responsible party
- Sponsor-investigator, Allison Sylvetsky (Meni), George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385888
- Sponsor's protocol ID
- Pro00012436
- Status last verified
- Aug 2025
- First submitted
- 8 May 2020
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sylvetsky AC, Moore HR, Kaidbey JH, Halberg SE, Cogen FR, DiPietro L, Elmi A, Goran MI, Streisand R. Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes. Contemp Clin Trials. 2021 Jul;106:106431. doi: 10.1016/j.cct.2021.106431. Epub 2021 May 8.
PubMed 33974993
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04385888
- Acronym / sponsor ID
- Pro00012436
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Allison Sylvetsky (Meni)University, hospital or other
- Collaborators
- Children's National Research Institute
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).
Detailed description
Eligible participants will be scheduled for a baseline visit. During the week prior, they will be instructed to continue usual dietary habits and complete an online photo-assisted food record, with parental assistance. At the baseline visit, height and weight will be measured, a spot urine sample will be collected, and a blood draw will be performed. Participants will have their CGM data for the past two weeks downloaded. In a subset of participants, an abdominal MRI will also be performed.
Subjects will then be randomized to either: 1) low-calorie sweetener (LCS) restriction or 2) continuation of usual LCS intake (control). All participants (both groups) and their parent will undergo a brief, 20-minute orientation where the PI and study dietitian will provide an introduction to the study, instructions on completing food records, education on CGM. Those in the intervention group will be given sample replacement beverages and a brochure on avoiding LCS to take home which will include a list of specific foods and beverages containing LCS to avoid during the study. Participants in the control group will be counseled on healthy eating as those in the intervention group (in accordance with standard dietary guidance for T1D management), with the exception of information and resources for avoiding LCS.
In both groups, text messages will be sent to parents 3X/week with reminders that their child should avoid LCS or continue usual intake, per randomization. Adherence will be monitored through collection of spot-urine samples for measurement of sucralose and ace-K concentrations. daily text message beverage logs completed by the parent, and photo-assisted food records with parent assistance in Weeks 0, 1, 6, and 12. During Week 6, participants and their parent will attend a mid-intervention telemedicine booster visit, during which the PI and/or study RA will reinforce the intervention and remind participants to mail back a spot urine sample using materials provided by the study team at baseline. Participants will be reminded of the study instructions, including the importance of inserting the DEXCOM G6 sensor (provided by study team) at the beginning of Week 11.
At the end of Week 12, participants and their parent will return for follow-up. Participants will have their CGM data downloaded using DEXCOM Clarity™ software. Height and weight will be measured and a second blood draw performed. Those who had an MRI at the baseline visit (n=30) will undergo a second abdominal MRI. Those randomized to the intervention will be purposefully sampled and asked to complete a ~20 minute qualitative interview and ~5 minute satisfaction survey, together with their parent, about their study experience and the challenges of LCSB restriction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-calorie sweetener restriction | Experimental | Behavioral: Low-calorie sweetener restrictionParticipants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks. |
| Usual consumption/control | No intervention | –Participants will continue low-calorie sweetener consumption, as usual. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child 6-12 years old
- Report consumption of ≥ 12 oz. beverages with sucralose (+/- ace-K) or aspartame+ace-K per day
- Child has had a diagnosis of T1D for at least one year
- Parent/guardian has reliable phone and internet access
- Parent/guardian and child both speak English
Key exclusion criteria (5 listed)
- Child under 6 years of age
- Child older than 12 years of age
- Child consumes foods with low-calorie sweeteners more than 3 times per week
- Child consumes condiments with low-calorie sweeteners more than 3 times per week
- Child has poorly managed chronic disease other than T1D or is taking medications other than insulin
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 |
|---|---|---|
| Low-calorie sweetener restrictionParticipants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water | Behavioural | Low-calorie sweetener restriction |
Primary outcome
Glycemic Variability
Time frame: Baseline vs Weeks 11-12
Change in Time in Range (TIR)
2 secondary outcomes
Visceral Adiposity
Time frame: Baseline vs. Week 12
Change in Inflammatory Cytokines (TNF-alpha)
Time frame: Baseline vs Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33974993Sylvetsky AC, Moore HR, Kaidbey JH, Halberg SE, Cogen FR, DiPietro L, Elmi A, Goran MI, Streisand R. Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes. Contemp Clin Trials. 2021 Jul;106:106431. doi: 10.1016/j.cct.2021.106431. Epub 2021 May 8.
- Individual participant dataSharing planned: No
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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?
A study testing Low-calorie sweetener restriction in people with Type 1 Diabetes, run by Allison Sylvetsky (Meni) at 1 site in United States.
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 6 inclusion and 5 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 26 Aug 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycemic Variability (time frame: Baseline vs Weeks 11-12). 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 NCT04385888, 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 26 Aug 2025.