Trial Outcomes & Findings for Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes (NCT NCT03997409)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Baseline to week 12

Results posted on

2023-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Low Carbohydrate Diet The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	Standard Carbohydrate Diet The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	No Dietary Recommendations This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.
Overall Study STARTED	14	13	12
Overall Study COMPLETED	10	12	11
Overall Study NOT COMPLETED	4	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Low Carbohydrate Diet The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	Standard Carbohydrate Diet The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	No Dietary Recommendations This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.
Overall Study Protocol Violation	1	1	0
Overall Study Withdrawal by Subject	3	0	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Carbohydrate Diet n=14 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	Standard Carbohydrate Diet n=13 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	No Dietary Recommendations n=12 Participants This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.	Total n=39 Participants Total of all reporting groups
Age, Continuous	15.5 years n=5 Participants	16 years n=7 Participants	15.5 years n=5 Participants	15.5 years n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	39 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	39 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to week 12

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

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=10 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	Standard Carbohydrate Diet n=12 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	No Dietary Recommendations n=11 Participants This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.
Change in HbA1c	0.4 percentage Interval 0.1 to 0.4	0.3 percentage Interval -0.2 to 0.5	-0.2 percentage Interval -0.3 to 0.2

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant

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.

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=9 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	Standard Carbohydrate Diet n=11 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	No Dietary Recommendations n=11 Participants This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.
Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL	-3 percentage Interval -9.2 to 6.2	-8.9 percentage Interval -13.0 to 7.2	3.4 percentage Interval 0.8 to 10.7

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant

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.

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=9 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	Standard Carbohydrate Diet n=11 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	No Dietary Recommendations n=11 Participants This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.
Percent of Time Spent Above the Glycemic Target of 140 mg/dL	-1.4 percentage Interval -15.8 to 4.5	-1.9 percentage Interval -6.1 to 4.4	-1.9 percentage Interval -5.3 to 2.7

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant

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.

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=9 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the LCD intervention will consume 25-35% of total daily intake from carbohydrates, 45-65% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	Standard Carbohydrate Diet n=11 Participants The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine. Participants on the SCD intervention will consume 45-65% of total daily caloric intake from carbohydrates, 25-35% from fat and 10-30% from protein. Dietary Intervention: The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.	No Dietary Recommendations n=11 Participants This group will serve as a control that receives the same number of education sessions as LCD and SCD group to teach general diabetes management but without specific dietary recommendations.
Percent of Time Spent Below the Glycemic Target of 70 mg/dL	0 percentage Interval -0.1 to 1.2	0 percentage Interval -0.3 to 1.2	-0.2 percentage Interval -0.4 to 0.3

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant

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.