NCT04385888

Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes

Completed NA Results posted Last updated 26 August 2025

What this trial tests

NA trial testing Low-calorie sweetener restriction in Type 1 Diabetes in 62 participants. Completed in 30 December 2023.

Timeline

28 October 2020

Primary endpoint
30 December 2023

30 December 2023

Quick facts

Lead sponsor	Allison Sylvetsky (Meni)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	62
Start date	28 October 2020
Primary completion	30 December 2023
Estimated completion	30 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Low-calorie sweetener restriction

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Allison Sylvetsky (Meni)

Who can join

Adults 6 to 12, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Glycemic Variability Primary · Baseline vs Weeks 11-12

Change in Time in Range (TIR)

Group	Value	95% CI
Low-calorie Sweetener Restriction	2.00	± 2.59
Usual Consumption/Control	3.91	± 2.59

Visceral Adiposity Secondary · Baseline vs. Week 12

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.

Group	Value	95% CI
Low-calorie Sweetener Restriction	0.1	± 1.1
Usual Consumption/Control	1.0	± 0.8

Change in Inflammatory Cytokines (TNF-alpha) Secondary · Baseline vs Week 12

We will collect a blood sample to measure TNF-alpha and calculate the change from baseline.

Group	Value	95% CI
Low-calorie Sweetener Restriction	0.08	± 0.07
Usual Consumption/Control	-0.23	± 0.08

Sponsor's own description

This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impacts of the COVID-19 Pandemic on Pediatric Type 1 Diabetes Management: A Qualitative Study.
   Ferguson K, Moore H, Kaidbey JH, Khattak S, et al · · 2022 · cited 9× · PMID 36154537 · DOI 10.1177/26350106221125701
2. Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes.
   Sylvetsky AC, Moore HR, Kaidbey JH, Halberg SE, et al · · 2021 · cited 3× · PMID 33974993 · DOI 10.1016/j.cct.2021.106431