Safety and Feasibility of a Low Carbohydrate Diet in Children With Type 1 Diabetes

Good glycemic control in individuals with Type 1 diabetes (T1D), has been proven to reduce the risk of diabetes-related complications. Despite technological advances such as the use of insulin delivery devices and continuous glucose monitoring, the average glycemic control in T1D is poor. Though dietary management plays a major role in the overall management of T1D, and it is often classified as the most challenging aspect of treatment, the 2019 Standards of Medical Care in Diabetes for children and adolescents do not clearly address dietary management. As carbohydrate is the macronutrient with the greatest impact on blood glucose, it is reasonable to suggest that carbohydrate reduction will minimize postprandial glucose excursions and improve diabetes control. For this reason, low carbohydrate diets (LCD) have gained popularity, and observational studies report positive glycemic outcomes. However, to date, scientific evidence from randomized trials on the impact of LCD in children with T1D is lacking. Thus, the over-arching goal of this pilot study is to evaluate the feasibility and safety of a low carbohydrate diet in children with T1D, and as an exploratory aim, we will evaluate the efficacy of LCD on glycemic control.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Low carbohydrate diet

Detailed Description

The investigators aim to study 40 subjects ages 5-11 with T1D to evaluate the feasibility of LCD. Participants will be asked to attend a total of 5 visits (4 in person and 1 phone visit) during the 6 month-duration of the study. Participants will be randomized to an intervention group with a LCD (50% of carbohydrate recommended daily allowance) vs. the standard diet.

During the screening visit, participants will be assessed by a dietitian to categorize their existing dietary regimen before randomization to either the LCD or the standard diet. In addition, participant's insulin regimen (either pump settings or multiple dose insulin injection therapy) will be reviewed for insulin dose adjustments as needed over a 2 week-period.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St Louis Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 5-11 years of age, with history of Type 1 diabetes for longer than 2 years,
• No carbohydrate restrictions at the time of recruitment.
• No medications that could affect appetite
• Regular attendance at the clinic (3-4 times per year),
• Glycated hemoglobin (HbA1c) <10%.

Exclusion Criteria:

• Impaired renal or liver function,
• Chronic seizures or global developmental delay,
• Diagnosed with ADHD and/or on ADHD medications
• Use of drugs other than insulin affecting glucose metabolism
• Severe eczema
• Celiac disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low carb diet intervention group; Low carbohydrate diet defined as 25-35% of total energy intake	Other: Low carbohydrate diet; 25-35% of carbohydrates from total energy intake
NO_INTERVENTION: Control; Standard diet defined as 45-65% total energy intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hypoglycemic events	Using a continuous glucose monitor (CGM) and home glucose meter, investigators will calculate the number of hypoglycemic events (glucose values <70 mg/dL but ≥ 54 mg/dL and those <54 mg/dL), number of severe hypoglycemia and time spent in hypoglycemia (values <70 mg/dL but ≥ 54 mg/dL and <54 mg/dL).	6 month study period
Episodes of diabetes related visits to the hospital, DKA	Investigators will obtain data prospectively from medical records and will estimate the frequency of DKA, diabetes related hospitalizations / emergency department visits.	6 month study period
Dyslipidemia	Investigators will evaluate the changes in LDL levels among the study groups.	6 month study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Investigators will evaluate the changes in glycemic control among the groups using HbA1c at baseline, 3 and 6 months.	6 month duration of the study
Glucose variability	Using CGM data investigators will evaluate glucose variability using standard deviation (SD) of all glucose values. Secondary endpoints will include time of the day spent in range (values between 70-140 mg/dl and between 70 and 180mg/dl), in hypoglycemia (values <70 mgl/dl but ≥ 54 mg/dl and <54 mg/dl) and in hyperglycemia (values >180mg/dl and >250 mg/dl).	6 month study period

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: ICTS BJH; Center for Diabetes Translation Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2020
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 201911121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No