NCT04082884 is a NA clinical trial of Very Low Carbohydrate Diet in Type 1 Diabetes, sponsored by Yale University.

Who is sponsoring NCT04082884?

NCT04082884 is sponsored by Yale University.

What drugs are being tested in NCT04082884?

Interventions in NCT04082884: Very Low Carbohydrate Diet.

What condition does NCT04082884 study?

NCT04082884 studies Type 1 Diabetes.

Is NCT04082884 still recruiting?

NCT04082884 is currently completed. Last updated 15 February 2024.

Are results published for NCT04082884?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-15 · How we verify

NCT04082884

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes

Completed NA Results posted Last updated 15 February 2024

What this trial tests

NA trial testing Very Low Carbohydrate Diet in Type 1 Diabetes in 6 participants. Completed in 20 February 2022.

Timeline

25 June 2020

Primary endpoint
20 February 2022

20 February 2022

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	25 June 2020
Primary completion	20 February 2022
Estimated completion	20 February 2022
Sites	1 location across United States

Drugs / interventions tested

Very Low Carbohydrate Diet

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Yale University

Who can join

Adults 13 to 25, 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.

Percentage of Time in Target Range of 70-180 mg/dL. Primary · 2 weeks per intervention, up to 7 weeks

The target range is 70 mg/dL - 180 mg/dL based on sensor-derived glucose levels. The outcome is reflected as the percentage of time spent in this range during the time frame.

Baseline

Group	Value	95% CI
Overall Participants	49.64	± 19.92

Standard Carbohydrate Diet

Group	Value	95% CI
Overall Participants	48.86	± 15.41

High Protein Very Low Carbohydrate Diet

Group	Value	95% CI
Overall Participants	60.78	± 16.57

High Fat Very Low Carbohydrate Diet

Group	Value	95% CI
Overall Participants	50.1	± 16.83

Percentage of Time Spent > 180 mg/dL to 250 mg/dl Secondary · 2 weeks per intervention, up to 7 weeks

The percent of time spent \> 180 mg/dL to 250 mg/dl based on sensor-derived glucose values. Reflected is the percentage of time spent in the range of 181-250 mg/dL.

Baseline

Group	Value	95% CI
Overall Participants	25.7	± 3.19

Standard Carbohydrate

Group	Value	95% CI
Overall Participants	25.36	± 5.15

High Protein/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	21.94	± 5.75

High Fat/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	21.32	± 2.65

Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values Secondary · 2 weeks per intervention, up to 7 weeks

The percent of time spent \> 250 mg/dL based on sensor-derived glucose values. Presented is the percentage of time people spent in the range.

Baseline

Group	Value	95% CI
Overall Participants	22.58	± 19.24

Standard Carbohydrate

Group	Value	95% CI
Overall Participants	21.36	± 14.07

High Protein/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	14.32	± 13.17

High Fat/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	24.95	± 17.68

Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values Secondary · 2 weeks per intervention, up to 7 weeks

The percent of time spent \> = 55 to \< 70 mg/dL based on sensor-derived glucose values. Reflected is the percentage of time within range.

Baseline

Group	Value	95% CI
Overall Participants	1.22	± 1.61

Standard Carbohydrate

Group	Value	95% CI
Overall Participants	2.96	± 3.19

High Protein/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	2.26	± 1.93

High Fat/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	2.65	± 2.28

Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values Secondary · 2 weeks per intervention, up to 7 weeks

The percent of time spent \< 55 mg/dL based on sensor-derived glucose values during the timeframe. Presented is the percentage of overall time spent in the specified range.

Baseline

Group	Value	95% CI
Overall Participants	0.68	± 1.29

Standard Carbohydrate

Group	Value	95% CI
Overall Participants	1.46	± 2.23

High Protein/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	0.68	± 0.59

High Fat/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	1.15	± 1.06

Total Daily Insulin Dose Secondary · 2 weeks per intervention, up to 7 weeks

The total daily insulin dose will be defined as the average total daily insulin dose will be calculated over 2 weeks. Values represent the mean units/kg/day for the 2 week period.

Baseline

Group	Value	95% CI
Overall Participants	0.78	± 0.09

Standard Carbohydrate

Group	Value	95% CI
Overall Participants	0.82	± 0.06

High Protein/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	0.60	± 0.08

High Fat/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	0.69	± 0.12

Average Sensor Glucose Level Secondary · 2 weeks per intervention, up to 7 weeks

The average sensor glucose level recorded by the continuous glucose monitor over the 2 week dietary period in mg/dL.

Baseline

Group	Value	95% CI
Overall Participants	193	± 44

Standard Carbohydrate

Group	Value	95% CI
Overall Participants	186	± 35

High Protein/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	169	± 30

High Fat/Very Low Carbohydrate

Group	Value	95% CI
Overall Participants	193	± 41

Sponsor's own description

This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Very Low Carbohydrate Diet

Trials testing the same drug.

NCT03221920 — Very Low Carbohydrate Diet Effects to GPS, Serum Lactate and TNF Alpha on Colorectal Cancer · NA · unknown

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04082884 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 15 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04082884.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04082884

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Very Low Carbohydrate Diet

Other recruiting trials for Type 1 Diabetes

Other Yale University trials

Verify against primary sources