Type 1 Diabetes
Conditions
Keywords
Low Carbohydrate Diet, Standard Carbohydrate Diet
Brief summary
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.
Interventions
OTHERDietary Intervention
The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline to week 12 | HbA1c (%) change will be measured from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time Spent Above the Glycemic Target of 140 mg/dL | Baseline to Week 12 | 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. |
| Percent of Time Spent Below the Glycemic Target of 70 mg/dL | Baseline to Week 12 | 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. |
| Percent of Time Spent in Hypoglycemia Below 50 mg/dL | Baseline to Week 12 | 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. |
| Change in Average Blood Glucose | Baseline to 12 weeks | 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. |
| Change in the Blood Glucose Standard Deviation | Baseline to 12 weeks | Change in the blood glucose standard deviation 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. |
| Change in Average Total Daily Dose of Insulin | Baseline to 12 weeks | Average Total Daily Dose of Insulin is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis. |
| Change in Average Bolus Amount of Insulin Per Day | Baseline to 12 weeks | Average bolus amount of Insulin per day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis. |
| Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL | Baseline to Week 12 | 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. |
| Change in Low Density Lipoprotein Particle Number | Baseline to 12 weeks | The number of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy. |
| Change in High Density Lipoprotein Particle Number | Baseline to 12 weeks | The number of High Density Lipoprotein Particles (HDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy. |
| Change in Small Low Density Lipoprotein Particle Number | Baseline to 12 weeks | The number of Small Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy. |
| Change in Low Density Lipoprotein Size | Baseline to 12 weeks | The size of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy. |
| Change in Concentration of Serum Ketones (Beta-hydroxybutyrate) | Baseline to 12 weeks | Change is measured by difference in concentration of serum ketones (beta-hydroxybutyrate) |
| Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module | Baseline to week 12 | The PedsQL 3.0 Teen Report (ages 13-18) is composed of 28 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). The total possible range of scores 0-112 Higher scores indicate higher quality of life. |
| Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report | Baseline to week 12 | Diabetes burden was measured using the Problem Areas in Diabetes (PAID-T) parent-report, a measure of how bothersome day-to-day problems are for adolescents with type 1 diabetes. The he PAID-T is a 26 item measure scored on a likert scale from one-to-six with a total possible scale score ranging from 26-156. A lower score represents less burden. |
| Change in Average Basal Amount of Insulin Per Day | Baseline to 12 weeks | Average Basal Amount of Insulin Per Day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 13 |
| 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. | 12 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Low Carbohydrate Diet | Standard Carbohydrate Diet | No Dietary Recommendations |
|---|---|---|---|---|
| Age, Continuous | 15.5 years | 15.5 years | 16 years | 15.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 14 Participants | 13 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 14 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Female | 19 Participants | 7 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Male | 20 Participants | 7 Participants | 7 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 14 | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 12 |
Outcome results
Primary
Change in HbA1c
HbA1c (%) change will be measured from baseline to 12 weeks
Time frame: Baseline to week 12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in HbA1c | 0.4 percentage |
| Standard Carbohydrate Diet | Change in HbA1c | 0.3 percentage |
| No Dietary Recommendations | Change in HbA1c | -0.2 percentage |
Secondary
Change in Average Basal Amount of Insulin Per Day
Average Basal Amount of Insulin Per Day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Average Basal Amount of Insulin Per Day | 0.2 units of insulin / day |
| Standard Carbohydrate Diet | Change in Average Basal Amount of Insulin Per Day | -0.2 units of insulin / day |
| No Dietary Recommendations | Change in Average Basal Amount of Insulin Per Day | 0.2 units of insulin / day |
Secondary
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.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Average Blood Glucose | 6 mg/dL |
| Standard Carbohydrate Diet | Change in Average Blood Glucose | 7 mg/dL |
| No Dietary Recommendations | Change in Average Blood Glucose | -11.5 mg/dL |
Secondary
Change in Average Bolus Amount of Insulin Per Day
Average bolus amount of Insulin per day is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Average Bolus Amount of Insulin Per Day | 3.3 units of insulin/day |
| Standard Carbohydrate Diet | Change in Average Bolus Amount of Insulin Per Day | 5.1 units of insulin/day |
| No Dietary Recommendations | Change in Average Bolus Amount of Insulin Per Day | -1.7 units of insulin/day |
Secondary
Change in Average Total Daily Dose of Insulin
Average Total Daily Dose of Insulin is calculated from data collected from the the use of an insulin pump by participants. T1DM participants were instructed in the use of an insulin pump for the adminsitration of insulin during the study. Instructions included administering all insulin via insulin pump and recording all carbohydrates consumed into the insulin pump. T1DM participants were instructed how to upload insulin pump data into a HIPAA and FDA-compliant cloud-based, data-integration platform for analysis.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Average Total Daily Dose of Insulin | 2.7 units of insulin/day |
| Standard Carbohydrate Diet | Change in Average Total Daily Dose of Insulin | 4.8 units of insulin/day |
| No Dietary Recommendations | Change in Average Total Daily Dose of Insulin | -1.9 units of insulin/day |
Secondary
Change in Concentration of Serum Ketones (Beta-hydroxybutyrate)
Change is measured by difference in concentration of serum ketones (beta-hydroxybutyrate)
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Concentration of Serum Ketones (Beta-hydroxybutyrate) | -0.04 Millimoles per liter (mmol/L) |
| Standard Carbohydrate Diet | Change in Concentration of Serum Ketones (Beta-hydroxybutyrate) | -0.03 Millimoles per liter (mmol/L) |
| No Dietary Recommendations | Change in Concentration of Serum Ketones (Beta-hydroxybutyrate) | -0.02 Millimoles per liter (mmol/L) |
Secondary
Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report
Diabetes burden was measured using the Problem Areas in Diabetes (PAID-T) parent-report, a measure of how bothersome day-to-day problems are for adolescents with type 1 diabetes. The he PAID-T is a 26 item measure scored on a likert scale from one-to-six with a total possible scale score ranging from 26-156. A lower score represents less burden.
Time frame: Baseline to week 12
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 3 participants; Standard Carb Diet: 4 participants; No Dietary Recommendations: 2 participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report | 3 units on a scale |
| Standard Carbohydrate Diet | Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report | -5.5 units on a scale |
| No Dietary Recommendations | Change in Diabetes Burden as Measured by the Problem Areas in Diabetes: Teen Version (PAID-T) Report | 4 units on a scale |
Secondary
Change in High Density Lipoprotein Particle Number
The number of High Density Lipoprotein Particles (HDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in High Density Lipoprotein Particle Number | -1 Nanomoles per liter (nmol/L) |
| Standard Carbohydrate Diet | Change in High Density Lipoprotein Particle Number | 1.5 Nanomoles per liter (nmol/L) |
| No Dietary Recommendations | Change in High Density Lipoprotein Particle Number | -2.3 Nanomoles per liter (nmol/L) |
Secondary
Change in Low Density Lipoprotein Particle Number
The number of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Low Density Lipoprotein Particle Number | 30 Nanomoles per liter (nmol/L) |
| Standard Carbohydrate Diet | Change in Low Density Lipoprotein Particle Number | -41 Nanomoles per liter (nmol/L) |
| No Dietary Recommendations | Change in Low Density Lipoprotein Particle Number | 47 Nanomoles per liter (nmol/L) |
Secondary
Change in Low Density Lipoprotein Size
The size of Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Low Density Lipoprotein Size | 0 nanometer (nm) |
| Standard Carbohydrate Diet | Change in Low Density Lipoprotein Size | -0.15 nanometer (nm) |
| No Dietary Recommendations | Change in Low Density Lipoprotein Size | 0.2 nanometer (nm) |
Secondary
Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module
The PedsQL 3.0 Teen Report (ages 13-18) is composed of 28 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). The total possible range of scores 0-112 Higher scores indicate higher quality of life.
Time frame: Baseline to week 12
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 3 participants; Standard Carb Diet: 4 participants; No Dietary Recommendations: 2 participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module | -5 units on a scale |
| Standard Carbohydrate Diet | Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module | -5.5 units on a scale |
| No Dietary Recommendations | Change in Score of Pediatric Quality of Life Inventory (PedsQL) Diabetes Module | -3 units on a scale |
Secondary
Change in Small Low Density Lipoprotein Particle Number
The number of Small Low Density Lipoprotein Particles (LDL-P) is directly measured using nuclear magnetic resonance (NMR) spectroscopy.
Time frame: Baseline to 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 2 participants; Standard Carb Diet: 2 participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in Small Low Density Lipoprotein Particle Number | -2.5 Nanomoles per liter (nmol/L) |
| Standard Carbohydrate Diet | Change in Small Low Density Lipoprotein Particle Number | 40 Nanomoles per liter (nmol/L) |
| No Dietary Recommendations | Change in Small Low Density Lipoprotein Particle Number | -12 Nanomoles per liter (nmol/L) |
Secondary
Change in the Blood Glucose Standard Deviation
Change in the blood glucose standard deviation 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 12 weeks
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Change in the Blood Glucose Standard Deviation | 0 mg/dL |
| Standard Carbohydrate Diet | Change in the Blood Glucose Standard Deviation | 0 mg/dL |
| No Dietary Recommendations | Change in the Blood Glucose Standard Deviation | -3 mg/dL |
Secondary
Percent of Time Spent Above the Glycemic Target of 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
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Percent of Time Spent Above the Glycemic Target of 140 mg/dL | -1.4 percentage |
| Standard Carbohydrate Diet | Percent of Time Spent Above the Glycemic Target of 140 mg/dL | -1.9 percentage |
| No Dietary Recommendations | Percent of Time Spent Above the Glycemic Target of 140 mg/dL | -1.9 percentage |
Secondary
Percent of Time Spent Below the Glycemic Target of 70 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
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Percent of Time Spent Below the Glycemic Target of 70 mg/dL | 0 percentage |
| Standard Carbohydrate Diet | Percent of Time Spent Below the Glycemic Target of 70 mg/dL | 0 percentage |
| No Dietary Recommendations | Percent of Time Spent Below the Glycemic Target of 70 mg/dL | -0.2 percentage |
Secondary
Percent of Time Spent in Hypoglycemia Below 50 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
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Percent of Time Spent in Hypoglycemia Below 50 mg/dL | 0 percentage |
| Standard Carbohydrate Diet | Percent of Time Spent in Hypoglycemia Below 50 mg/dL | 0.1 percentage |
| No Dietary Recommendations | Percent of Time Spent in Hypoglycemia Below 50 mg/dL | 0 percentage |
Secondary
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
Population: Data was not collected for the following participants due to missed study visit: Low Carb Diet: 1 participant; Standard Carb Diet: 1 participant
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Low Carbohydrate Diet | Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL | -3 percentage |
| Standard Carbohydrate Diet | Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL | -8.9 percentage |
| No Dietary Recommendations | Percent of Time Spent in the Glycemic Target of 70 - 140 mg/dL | 3.4 percentage |