Carbohydrates Under Target for Type 1 Diabetes Management

McGill University

Status: Terminated

Conditions: Type 1 Diabetes

Treatments: Other: Control Diet; Other: VLCHF Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04084418

CUT-T1D

Details and patient eligibility

About

Recently there has been an increased interest in limiting intake of carbohydrates (CHO) for improving long term health. While healthcare professionals (HCPs) are sometimes reluctant to limit the CHO intake due to the lack of information related to safety issues, low CHO diets are increasing in popularity amongst both people with and without diabetes. One of these diets, the very low CHO high fat diet (VLCHF) raises concern on its impact on the lipid profile, liver, response to glucagon, and insulin dose adjustments when adopting it in the context of type 1 diabetes (T1D). The investigators recently conducted a series of interviews with people with diabetes following a VLCHF diet (Brazeau et al. Manuscript in preparation) to inquire on their reasons for adopting VLCHF as well as challenges they faced. The main reasons to initiate the diet were to limit blood glucose fluctuations and reduce medication. An issue that was frequently mentioned during the interviews was the lack of support from HCPs which often leads to not discussing it with said HCP. This is an important source of concern that can lead to additional safety issues. Our goal is to provide information regarding the safety of a VLCHF diet for T1D and the individualized insulin adjustments required.

The investigators aim to evaluate the changes in daily blood glucose fluctuations after 6 weeks of a VLCHF diet, to monitor the changes in the insulin dosing and to measure impact on lipid profiles, response to glucagon, and liver function.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Duration of Type 1 Diabetes > 12 months
• On intensive insulin therapy for > 6 months
• Own a smartphone or tablet to use two mobile applications : Keenoa and Piezo: Achieve the Guidelines!

Exclusion criteria

• Known gastroparesis (clinical diagnosis)
• Advanced kidney disease (eGFR < 50 mL/min)
• Known significant liver disease (e.g., cirrhosis, active hepatitis, liver transplantation)
• Recent (< 6 months) major cardiovascular even (e.g. myocardial infarction, cerebrovascular accident, major revascularization, etc.)
• Pregnancy (ongoing or planned in the next 6 months)
• Breastfeeding
• Severe hypoglycemia episodes or ketoacidosis in the 4 weeks prior to recruitment
• Claustrophobia or presence of metal devices/implants in the body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Control diet followed by VLCHF diet

Experimental group

Description:

* Phase 1 (1 to 3 weeks): Insulin dose optimization with usual diet * Phase 2 (6 weeks): Control diet (50% of energy from carbohydrates) * Phase 3 (4 weeks): Washout period * Phase 4 (6 weeks): VLCHF diet (10% of energy from carbohydrates)

Treatment:

Other: Control Diet

Other: VLCHF Diet

VLCHF diet followed by Control diet

Experimental group

Description:

* Phase 1 (1 to 3 weeks): Insulin dose optimization with usual diet * Phase 2 (6 weeks): VLCHF diet (10% of energy from carbohydrates) * Phase 3 (4 weeks): Washout period * Phase 4 (6 weeks): Control diet (50% of energy from carbohydrates)

Treatment:

Other: Control Diet

Other: VLCHF Diet