Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes

Vanderbilt University Medical Center39 enrolled

Overview

Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 13 YearsMax age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with T1DM for at least 12 months * Age 13 to 21 years * Total daily dose of insulin 0.5 to 1.25 units/kg/day * Current use of an insulin pump and CGM * HbA1c between 7% and 10% * Tanner stage 3 to 5 on physical exam * Participant or parent of participant use of smart phone * Able to read and speak English Exclusion Criteria: * Any episode of diabetic ketoacidosis (DKA) in the last 12 months * Any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, IV dextrose or oral carbohydrate administered by another person) in the last 12 months * Any prior abnormal fasting lipid panel (LDL \> 130) * Additional dietary restrictions * Following a weight-loss or otherwise restrictive diet * Use of medication or supplements other than insulin to control blood glucose * Use of medication or other supplements to lower lipids * Pregnancy or breast feeding * History of hemoglobinopathy

Outcomes

Primary Outcomes

Change in HbA1c

HbA1c (%) change will be measured from baseline to 12 weeks

Time frame: Baseline to week 12

Secondary Outcomes

Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL

Percent of time is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.

Time frame: Baseline to Week 12

Percent of Time Spent Above the Glycemic Target of 140 mg/dL

Time frame: Baseline to Week 12

Percent of Time Spent Below the Glycemic Target of 70 mg/dL

Time frame: Baseline to Week 12

Percent of Time Spent in Hypoglycemia Below 50 mg/dL

Time frame: Baseline to Week 12

Change in Average Blood Glucose

Change in average blood glucose is calculated from data collected from the continuous glucose monitor worn by participants. T1DM participants were instructed in the use of a continuous glucose monitor (CGM) for the monitoring of glycemia during the study. Participants were shown how to upload CGM data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.