The LATTITUDE Study - Low Carbohydrate Diet and Automated Insulin Delivery System for Type 1 Diabetes

Trial ID: NCT05449678

Interventional - Phase Unknown - Unknown status

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

Interventions

• Low-carb diet

Eligibility

Inclusion criteria

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

Exclusion criteria

• 1. Self-reported having a diet with \< 35% energy from carb.
• 2. Seldom (\<20% of scenario) or never count carbohydrate intake.
• 3. 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)
• 4. Recent (\< 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).
• 5. Self-reported significant liver disease (e.g. cirrhosis, active hepatitis, liver transplantation)
• 6. Self-reported uncontrolled thyroid disease (unless stable treatment for 8 weeks at inclusion with TSH within target range).
• 7. Self-reported one or more severe hypoglycemic episodes within two weeks of screening.
• 8. Self-reported one or more severe hyperglycemic episodes requiring hospitalization in the last 3 months.
• 9. 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.
• 10. 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.
• 11. Plan to go abroad in a foreign country during the study period for a duration \> 4 weeks.
• 12. Pregnancy (ongoing or current attempt to become pregnant).
• 13. Breastfeeding.
• 14. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).
• 15. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®).
• 16. 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.
• 17. Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed.
• 18. Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.
• 19. In the opinion of the investigator, a participant who is unable or unwilling to complete the study.

Sponsor

Institut de Recherches Cliniques de Montreal

Source: ClinicalTrials.gov

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