Type 1 DiabetesLATITUDENCT05449678
Low cArbohydraTe dIeT and aUtomated Insulin Delivery System for Type 1 DiabetEs
A study testing Low-carb diet in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Low-carb diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
Zekai Wu, MD, PhD contact
About this study
Official title: The LATTITUDE Study - Low Carbohydrate Diet and Automated Insulin Delivery System for Type 1 Diabetes
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Low-carb diet
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-carb dietBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Low-carb diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (1)
Adherence
Adherence to the prescribed diet (average % CHO intakes/day; number of days with +/- 5% CHO of prescribed diet; % meals following +/-5% targeted CHO)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Remi Rabasa-Lhoret, MD, PhD, Study director, IRCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449678
- Sponsor's protocol ID
- 2023-1182
- Acronym
- LATITUDE
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LATTITUDE Study - Low Carbohydrate Diet and Automated Insulin Delivery System for Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05449678
- Acronym / sponsor ID
- LATITUDE / 2023-1182
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control diet | No intervention | –Usual diet (45% of daily energy intake from CHO) |
| Low carb diet | Experimental | Behavioral: Low-carb dietLow-carb diet (25% of daily energy intake from CHO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-carb dietA 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). | Behavioural | Low carb diet |
Primary outcome
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).
1 secondary outcome
Adherence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekai Wu, MD, PhD contact
Remi Rabasa-Lhoret, MD, PhD study director
IRCM
Questions about this trial
What is this clinical trial studying?
A study testing Low-carb diet in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valérie Boudreau, PhD (514 987-5643, valerie.boudreau@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.