Evidence map›Paper›PMID 33974993›Full record

ArticleContemporary clinical trials2021

Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes.

Allison C Sylvetsky, Hailey R Moore, Jasmine H Kaidbey, Sabrina E Halberg, Fran R Cogen, Loretta DiPietro, Angelo Elmi, Michael I Goran, Randi Streisand

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04385888 (Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04385888 nacompletednot on this map

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

TypeinterventionalSponsorAllison Sylvetsky (Meni)Ran2020 to 2023Enrolled62ConditionsType 1 DiabetesArmsLow-calorie sweetener restriction
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Allison C SylvetskyDepartment of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA. Electronic address: asylvets@gwu.edu.
Hailey R MooreDivision of Psychology & Behavioral Health, Children's National Hospital, 111 Michigan Avenue NW, Washington, DC 20010, USA.
Jasmine H KaidbeyDepartment of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA.
Sabrina E HalbergDepartment of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA.
Fran R CogenDivision of Endocrinology, Children's National Hospital, 111 Michigan Avenue NW, Washington, DC 20010, USA; School of Medicine and Health Sciences, The George Washington University, 2300 I St. NW, Washington, DC 20052, USA.
Loretta DiPietroDepartment of Exercise and Nutrition Sciences, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Suite 200, Washington, DC 20052, USA.
Angelo ElmiDepartment of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Avenue NW, Washington, DC 20052, USA.
Michael I GoranDepartment of Pediatrics, The Saban Research Institute, Children's Hospital Los Angeles, 4650 Sunset Blvd, Los Angeles, CA 90027, USA.
Randi StreisandDivision of Psychology & Behavioral Health, Children's National Hospital, 111 Michigan Avenue NW, Washington, DC 20010, USA; School of Medicine and Health Sciences, The George Washington University, 2300 I St. NW, Washington, DC 20052, USA.
Children's National · USGeorge Washington University · USMilken Institute · USChildren's Hospital of Los Angeles · US

Funding

Effects of Low-calorie Sweetened Beverage Restriction in Youth with Type 1 DiabetesR21DK122345 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI SYLVETSKY, ALLISON · 2020 to 2021
$479k
NIDDK NIH HHS R21 DK122345
6 · The paper itself

Abstract

backgroundLow-calorie sweeteners (LCSs) provide sweetness without sugar or calories and are used to replace added sugars by many children with type 1 diabetes (T1D). However, the role of LCSs in diabetes management and cardiometabolic health is unclear.

objectiveThe Diabetes Research in Kids Study (DRINK-T1D) aims to investigate effects of LCS restriction on glycemic variability, visceral adiposity, lipid profiles, and systemic inflammation among children 6-12 years old with T1D.

methodsChildren with T1D, who report habitual consumption of foods and beverages containing LCSs, are recruited from the Washington Nationals Diabetes Care Complex (DCC) at Children's National Hospital (CNH) in Washington, DC. Following a phone screening and two-week run-in period involving continuation of usual LCS intake, children are randomized to 12 weeks of LCS restriction (replacement of diet beverages with still or sparkling water and avoidance of other sources of LCSs) or continued usual LCS intake (control). The primary outcome is the difference in change in glycemic variability in the LCS restriction group versus the control group. Change in glycemic variability will be assessed as the difference in daily average time-in-range (TIR), measured using continuous glucose monitoring (CGM) during two weeks at the end of the 12-week intervention, compared with during the two-week run-in period prior to randomization. Participants also complete a variety of anthropometric, metabolic, dietary, and behavioral assessments throughout the 14-week study.

conclusionsDRINK-T1D is an innovative, randomized controlled trial, evaluating effects of LCS restriction on glycemic variability and cardiometabolic health in children with T1D. Findings of DRINK-T1D will support or challenge the common practice of recommending LCS use in this patient population and will have clinically relevant implications for pediatric T1D management.

trial registrationClinicalTrials.gov Identifier NCT04385888.

Indexed as

Diabetes Mellitus, Type 1Blood GlucoseBlood Glucose Self-MonitoringChildEnergy IntakeHumansRandomized Controlled Trials as TopicSweetening AgentsBlood GlucoseSweetening AgentsArtificial sweetenersDiet sodaGlycemic controlPediatricsType 1 diabetes

Identifiers

PMID33974993
PMCPMC8222177
OpenAlexW3160585694

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.