MedTrace Logo

Low cArbohydraTe dIeT and aUtomated Insulin Delivery System for Type 1 DiabetEs

NCT05449678 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-07-28

No results posted yet for this study

Summary

This is a randomized, controlled study in people living with type 1 diabetes using an automated insulin delivery (AID) system. Participants will be assigned to a control diet (45% carbohydrate) or a low carb diet (25% carbohydrate). The objective is to establish whether the low-carb diet improves time to glycemic targets at 3 months and whether the diet is realistically maintained at 1 year in patients using an AID-DIY system.

Conditions

Interventions

BEHAVIORAL

Low-carb diet

A close nutritional follow-up will take place with a qualified nutritionist to adapt the participants' usual diet to their assignment diet. This is not a strict diet to follow or a ketogenic diet. Nutritional modifications will be based on the participants' usual diet to improve adherence (personalized follow-up).

Sponsors & Collaborators

  • Institut de Recherches Cliniques de Montreal

    lead OTHER

Principal Investigators

  • Remi Rabasa-Lhoret, MD, PhD · IRCM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-09-30
Completion
2025-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449678 on ClinicalTrials.gov