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

NCT05449678 | Unknown

• 1 other identifier: 2023-1182
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in range (TIR)

  The comparison between low-carb diet and usual diet regarding percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L (TIR%) based on sensor glucose value during week 11 and 12 (24-hour).

  12 weeks

Secondary Outcomes (1)

• Adherence

  1 year

Study Arms (2)

Control diet

NO INTERVENTION

Usual diet (45% of daily energy intake from CHO)

Low carb diet

EXPERIMENTAL

Low-carb diet (25% of daily energy intake from CHO)

Behavioral: Low-carb diet

Interventions

Low-carb diet BEHAVIORAL

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).

Low carb diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 years old
• Duration of T1D or latent autoimmune diabetes in adults (LADA) ≥ 12 months
• On automated insulin delivery system for ≥ 3 months
• Own a smartphone or tablet to use the mobile application: Keenoa
• Willing to share personal CGM data during the study period
• Reporting daily food intake \>3350 kJ (1200 kcal)
• Time in closed-loop mode during run-in period \> 70%

You may not qualify if:

• Self-reported having a diet with \< 35% energy from carb.
• Seldom (\<20% of scenario) or never count carbohydrate intake.
• Self-reported clinically significant nephropathy (eGFR \< 30 ml/min/1.73m2, planned or on dialysis or already followed by a nephrologist), or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery)
• Recent (\< 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).
• Self-reported significant liver disease (e.g. cirrhosis, active hepatitis, liver transplantation)
• Self-reported one or more severe hypoglycemic episodes within two weeks of screening.
• Self-reported one or more severe hyperglycemic episodes requiring hospitalization in the last 3 months.
• Anticipated therapeutic change (including change of insulin type \[switch to biosimilar is not considered as insulin change\] and/or type of CGM sensor, insulin pump or AID between admission and end of the study.
• To limit risk of interference for CGM accuracy: anticipated need to use acetaminophen during the study period at a dose above 1g every 6 hours and current or anticipated use of Hydroxyurea.
• Plan to go abroad in a foreign country during the study period for a duration \> 4 weeks.
• Pregnancy (ongoing or current attempt to become pregnant).
• Breastfeeding.
• Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).
• Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®).
• Current use of agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Remi Rabasa-Lhoret, MD, PhD

  IRCM

  STUDY DIRECTOR

Central Study Contacts

Valérie Boudreau, PhD

CONTACT

514 987-5643; valerie.boudreau@ircm.qc.ca

Zekai Wu, MD, PhD

CONTACT

zekai.wu@ircm.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: June 30, 2025
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share