Trial Outcomes & Findings for Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes (NCT NCT02888691)

Results Overview

Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

12 weeks - from baseline to end of study

Results posted on

2023-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Low Carbohydrate Diet \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet \> 250 grams of carbohydrate per day High carbohydrate diet
First Intervention Period STARTED	7	7
First Intervention Period COMPLETED	6	7
First Intervention Period NOT COMPLETED	1	0
Second Intervention Period STARTED	7	5
Second Intervention Period COMPLETED	7	3
Second Intervention Period NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Cohort n=14 Participants Baseline characteristics are for the whole study cohort, not for each of study arm of the cross-over study
Age, Continuous	44 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
body mass index	25 kg/m*m n=5 Participants
diabetes duration	19 years n=5 Participants
HbA1c	58 mmol/mol n=5 Participants
insulin pump use	7 years n=5 Participants
daily carbohydrate intake	145 grams n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks - from baseline to end of study

Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Percentage of Time Spent in Euglycemia	68.6 Percentage of time Standard Deviation 8.9	65.3 Percentage of time Standard Deviation 6.5

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Mean glucose value assessed by continuous glucose monitoring

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Mean Glucose	8.8 mmol/l Standard Deviation 0.7	8.9 mmol/l Standard Deviation 0.7

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Standard deviation of glucose values assessed by continuous glucose monitoring

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Standard Deviation of Glucose	2.9 mmol/l Standard Deviation 0.4	3.3 mmol/l Standard Deviation 0.4

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Coefficient of variation of glucose values assessed by continuous glucose monitoring

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Coefficient of Variation of Glucose	32.7 percentage Standard Deviation 3.2	37.5 percentage Standard Deviation 3.6

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Population: CGM data were collected, but the calculation of MAGE was not conducted. The analysis plan was changed as a result of changes in the guidelines for reporting of CGM-based measures. To calculate MAGE would require extensive work, and the results would be of no clinical relevance. Funding aquired for this project covers only clinically relevant analysis and ultimately, MAGE was not calculated due to lack of funding.

Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Time Spent in Hypoglycemia	1.9 Percentage of time Standard Deviation 1.8	3.6 Percentage of time Standard Deviation 2.1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Time spent with glucose values \> 10.0 mmol/l assessed by continuous glucose monitoring

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Time Spent in Hyperglycemia	29.5 Percentage of time Standard Deviation 9.0	31.1 Percentage of time Standard Deviation 7.3

SECONDARY outcome

Timeframe: From baseline to 12 weeks

Change in hemoglobin A1c

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=13 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=10 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Change in A1c	1 mmol/mol Standard Deviation 1	1 mmol/mol Standard Deviation 0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Population: CGM data were collected, but the calculation of AUC low was not conducted. The analysis plan was changed as a result of changes in the guidelines for reporting of CGM-based measures. To calculate AUC low would require extensive work, and the results would be of no clinical relevance. Funding aquired for this project covers only clinically relevant analysis and ultimately, AUC low was not calculated due to lack of funding.

Difference in area under the curve \<4.0 mmol/l assessed by continuous glucose monitoring

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Population: CGM data were collected, but the calculation of AUC high was not conducted. The analysis plan was changed as a result of changes in the guidelines for reporting of CGM-based measures. To calculate AUC high would require extensive work, and the results would be of no clinical relevance. Funding aquired for this project covers only clinically relevant analysis and ultimately, AUC high was not calculated due to lack of funding.

Difference in area under the curve \>10.0 mmol/l assessed by continuous glucose monitoring

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Population: Data cannot be reported because the data collection method was invalid.

Difference in post breakfast glucose excursion assessed by continuous glucose monitoring

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline to 12 weeks

Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=14 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Severe Hypoglycemia	0 events	0 events

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Total daily insulin dose

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Total Daily Dose	33.6 Units of insulin Standard Deviation 8.1	43.2 Units of insulin Standard Deviation 11.0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Total daily basal insulin dose in the time range 00:00-24:00

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Total Daily Basal Insulin 24 Hour	18.5 Units of insulin Standard Deviation 5.4	17.3 Units of insulin Standard Deviation 5.4

SECONDARY outcome

Timeframe: From baseline to 12 weeks

Total nighttime basal insulin in the time range 00:00-06:00

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Total daytime basal insulin in the time range 06:00-24:00

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Difference in total daily bolus insulin

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Total Daily Bolus Insulin	15.1 Units of insulin Standard Deviation 4.4	25.9 Units of insulin Standard Deviation 7.3

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Number of blood glucose readings

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Number of daily carbohydrate servings (one serving ≥ 15 grams)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=13 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=10 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Body Composition	-0.2 percentage of total body weight Standard Deviation 0.6	1.0 percentage of total body weight Standard Deviation 0.0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in weight

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=13 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=10 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Weight	1.9 kilogram Standard Deviation 0.3	1.7 kilogram Standard Deviation 1.6

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in hip circumference

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=13 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=10 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Hip Circumference	5.2 centimeter Standard Deviation 10.8	4.6 centimeter Standard Deviation 0.4

SECONDARY outcome

Timeframe: From baseline to 12 weeks

Change in waist circumference

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=13 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=10 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Waist Circumference	-1.9 centimeter Standard Deviation 0.5	0.0 centimeter Standard Deviation 1.8

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in systolic blood pressure

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Systolic Blood Pressure	4 mmHg Standard Deviation 1	12 mmHg Standard Deviation 5

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in diastolic blood pressure

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Diastolic Blood Pressure	2 mmHg Standard Deviation 4	7 mmHg Standard Deviation 4

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in heart rate

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Heart Rate	3 beats per minute Standard Deviation 0	1 beats per minute Standard Deviation 1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Diabetes Treatment Satisfaction	3.8 units on a scale Standard Deviation 2.7	4.9 units on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Hypoglycemia Fear	0 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 6.0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in total cholesterol

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Cholesterol	0.4 mmol/l Standard Deviation 0.0	0.2 mmol/l Standard Deviation 0.3

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in HDL

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
HDL	0.6 mmol/l Standard Deviation 0.0	0.03 mmol/l Standard Deviation 0.05

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in LDL

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
LDL	0.2 mmol/l Standard Deviation 0.0	0.2 mmol/l Standard Deviation 0.2

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in triglycerides

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Triglycerides	0.0 mmol/l Standard Deviation 0.1	0.1 mmol/l Standard Deviation 0.0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in free fatty acids

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in sodium

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Sodium	0 mmol/l Standard Deviation 1	1 mmol/l Standard Deviation 1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in potassium

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Potassium	0.2 mmol/l Standard Deviation 0.0	0.1 mmol/l Standard Deviation 0.1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in creatinine

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Creatinine	2 micromol/l Standard Deviation 1	2 micromol/l Standard Deviation 1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in urate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in albumin

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Albumin	1 g/l Standard Deviation 1	0 g/l Standard Deviation 0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in hemoglobin

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Hemoglobin	0.3 mmol/l Standard Deviation 0.1	0.2 mmol/l Standard Deviation 0.0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in leucocytes

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Leucocytes	0.1 cells/l Standard Deviation 0.2	0.2 cells/l Standard Deviation 0.1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in thrombocytes

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Thrombocytes	17 cells/l Standard Deviation 1	6 cells/l Standard Deviation 10

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in iron

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Iron	2 micromol/l Standard Deviation 4	4 micromol/l Standard Deviation 0

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in transferrin

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in ferritin

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in folate

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Folate	0.5 micromol/l Standard Deviation 0.1	0.3 micromol/l Standard Deviation 0.9

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in vitamin B-12

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Vitamin B-12	18 pmol/l Standard Deviation 8	35 pmol/l Standard Deviation 10

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in magnesium

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Magnesium	0.03 mmol/l Standard Deviation 0.00	0.02 mmol/l Standard Deviation 0.00

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in zinc

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Zinc	1 micromol/l Standard Deviation 1	0 micromol/l Standard Deviation 1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in urine albumin-creatinine ratio

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
U-alb-crea Ratio	1 mg/mmol Standard Deviation 4	3 mg/mmol Standard Deviation 1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in Supar

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in CRP

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in IL-1

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
IL-1	0.2 pg/ml Standard Deviation 0.3	0.9 pg/ml Standard Deviation 1.1

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in IL-6

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
IL-6	1.8 pg/ml Standard Deviation 7.1	6.5 pg/ml Standard Deviation 4.3

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in IL-8

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks - from baseline to end of study

Change in TNF-alpha

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
TNF-alpha	2.3 pg/ml Standard Deviation 3.0	2.8 pg/ml Standard Deviation 2.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks - from baseline to end of study

Daily carbohydrate intake assessed by insulin pump download

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=11 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Carbohydrate Intake	98 grams per day Standard Deviation 11	246 grams per day Standard Deviation 34

OTHER_PRE_SPECIFIED outcome

Timeframe: Spot test at week 0, 2, 4, 6, 8, 10 and 12

Morning blood ketone values obtained 7 times during the study period. A single value was calculated for each study participant based on an average of the 7 datapoints.

Outcome measures

Outcome measures
Measure	Low Carbohydrate Diet n=14 Participants \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 Participants \> 250 grams of carbohydrate per day High carbohydrate diet
Ketones	0.2 mmol/l Standard Deviation 0.1	0.1 mmol/l Standard Deviation 0.0

Adverse Events

Low Carbohydrate Diet

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

High Carbohydrate Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Carbohydrate Diet n=14 participants at risk \< 100 grams of carbohydrate per day Low carbohydrate diet	High Carbohydrate Diet n=12 participants at risk \> 250 grams of carbohydrate per day High carbohydrate diet
Endocrine disorders Diabetic ketoacidosis	7.1% 1/14 • Number of events 1 • 36 weeks	0.00% 0/12 • 36 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr Signe Schmidt

Steno Diabetes Center Copenhagen

Phone: +4551174785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place