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

Primary Purpose

Type 1 Diabetes

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Low-carb diet

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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%

Exclusion Criteria:

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 uncontrolled thyroid disease (unless stable treatment for 8 weeks at inclusion with TSH within target range).
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.
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.
Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.
In the opinion of the investigator, a participant who is unable or unwilling to complete the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control diet

Low carb diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Adherence

Adherence to the prescribed diet (average % CHO intakes/day; number of days with +/- 5% CHO of prescribed diet; % meals following +/-5% targeted CHO)

Full Information

NCT ID

NCT05449678

First Posted

July 4, 2022

Last Updated

July 26, 2022

Sponsor

Institut de Recherches Cliniques de Montreal

1. Study Identification

Unique Protocol Identification Number

NCT05449678

Brief Title

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

Acronym

LATITUDE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Recherches Cliniques de Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control diet

Arm Type

No Intervention

Arm Description

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

Arm Title

Low carb diet

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Low-carb diet

Intervention Description

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).

Primary Outcome Measure Information:

Title

Time in range (TIR)

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Adherence

Description

Adherence to the prescribed diet (average % CHO intakes/day; number of days with +/- 5% CHO of prescribed diet; % meals following +/-5% targeted CHO)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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% Exclusion Criteria: 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 uncontrolled thyroid disease (unless stable treatment for 8 weeks at inclusion with TSH within target range). 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. 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. Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator. In the opinion of the investigator, a participant who is unable or unwilling to complete the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valérie Boudreau, PhD

Phone

514 987-5643

valerie.boudreau@ircm.qc.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Zekai Wu, MD, PhD

zekai.wu@ircm.qc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Remi Rabasa-Lhoret, MD, PhD

Organizational Affiliation

IRCM

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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