N/A
N=62
Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04385888 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Glycemic Variability — 2.00; 3.91 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low-calorie sweetener restriction (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Allison Sylvetsky (Meni)
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Variability |
2.00; 3.91 | — |
| SECONDARY Visceral Adiposity |
0.1; 1.0 | — |
| SECONDARY Change in Inflammatory Cytokines (TNF-alpha) |
0.08; -0.23 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04385888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.