Low cArbohydraTe dIeT and aUtomated Insulin Delivery System for Type 1 DiabetEs (LATITUDE)
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|ClinicalTrials.gov Identifier: NCT05449678|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2022
Last Update Posted : July 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: Low-carb diet||Not Applicable|
Problems: Despite significant technological and treatment advances for people living with with type 1 diabetes (PWT1D), time in optimal glycemic targets remains difficult to achieve (between 4.0 and 10.0 mmol/L). On the other hand, there is increasing interest in low-carbohydrate diets in the general population (often for weight control), but also in people with diabetes, to help achieve glycemic control (associated with an increase in time in range (TIR).
Automated insulin delivery (AID) systems, including a continuous glucose monitor (CGM) coupled to an insulin pump with an integrated infusion algorithm, increase TIR by approximately 2 hours per day and reduce time in hypoglycemia by 30 minutes, compared to conventional treatments for type 1 diabetes. However, maintaining an optimal TIR remains a significant challenge for PWT1D, despite the increasing use of this technology.
AID systems in combination with a low-carbohydrate diet to optimize TIR have not been studied.
Objectives: To investigate whether low-carb diets improve glucose management and the feasibility of adopting low-carb diets among PWT1D using an AID.
Methods: This is a 12-month prospective, open-label, randomized, controlled study in adults living with type 1 diabetes, with the first 12 weeks as the main study phase and the rest as the extended study phase.
- Admission period (2-4 weeks): Optimization of insulin doses, validation of carbohydrate calculations and maintenance of usual diet.
- Main study period (3 months): Study assignment diet (low carbohydrate or usual).
- Extensive study phase (9 months): Maintenance of assignment diet (if possible) with less frequent visits (observation period).
Hypothesis: The low-carb diet would increase the TIR% (primary outcome) by a mean of 8% (SD 8) compared with the usual diet. Power calculation: Using mean 8% (SD 8), that 38 adults (19 for each group) would provide 80% power at the 5% significance level to detect differences between the two interventions, after considering a 10% drop-out rate.
Full analysis set is defined as participants who have finished recruitment. Per-protocol set is defined as participants who have finished recruitment and have at least 70% of CGM data, at least 70% time in closed-loop mode and at least 4 full days of diet data during week 3-4. The efficiency analysis will be performed using the per-protocol set. The safety analysis will be performed using the full analysis set.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The LATTITUDE Study - Low Carbohydrate Diet and Automated Insulin Delivery System for Type 1 Diabetes|
|Estimated Study Start Date :||September 1, 2022|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||June 30, 2025|
No Intervention: Control diet
Usual diet (45% of daily energy intake from CHO)
Experimental: Low carb diet
Low-carb diet (25% of daily energy intake from CHO)
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).
- Time in range (TIR) [ Time Frame: 12 weeks ]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).
- Adherence [ Time Frame: 1 year ]Adherence to the prescribed diet (average % CHO intakes/day; number of days with +/- 5% CHO of prescribed diet; % meals following +/-5% targeted CHO)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05449678
|Contact: Valérie Boudreau, PhD||514 email@example.com|
|Contact: Zekai Wu, MD, PhDfirstname.lastname@example.org|
|Study Director:||Remi Rabasa-Lhoret, MD, PhD||IRCM|