N/A
Completed N=14
Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes
Source: ClinicalTrials.gov NCT02888691 ↗Enrolled (actual)
14
Serious AEs
3.9%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Time Spent in Euglycemia — 68.6; 65.3 Percentage of time
Summary
The aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Spent in Euglycemia |
68.6; 65.3 | — |
| SECONDARY Mean Glucose |
8.8; 8.9 | — |
| SECONDARY Standard Deviation of Glucose |
2.9; 3.3 | — |
| SECONDARY Coefficient of Variation of Glucose |
32.7; 37.5 | — |
| SECONDARY Mean Amplitude of Glycemic Excursions |
— | — |
| SECONDARY Time Spent in Hypoglycemia |
1.9; 3.6 | — |
| SECONDARY Time Spent in Hyperglycemia |
29.5; 31.1 | — |
| SECONDARY Change in A1c |
1; 1 | — |
| SECONDARY AUC Low |
— | — |
| SECONDARY AUC High |
— | — |
| SECONDARY Post Breakfast Glucose Excursion |
— | — |
| SECONDARY Severe Hypoglycemia |
0; 0 | — |
| SECONDARY Total Daily Dose |
33.6; 43.2 | — |
| SECONDARY Total Daily Basal Insulin 24 Hour |
18.5; 17.3 | — |
| SECONDARY Total Nightime Basal Insulin |
— | — |
| SECONDARY Total Daytime Basal Insulin |
— | — |
| SECONDARY Total Daily Bolus Insulin |
15.1; 25.9 | — |
| SECONDARY Blood Glucose Readings |
— | — |
| SECONDARY Carbohydrate Servings |
— | — |
| SECONDARY Body Composition |
-0.2; 1.0 | — |
| SECONDARY Weight |
1.9; 1.7 | — |
| SECONDARY Hip Circumference |
5.2; 4.6 | — |
| SECONDARY Waist Circumference |
-1.9; 0.0 | — |
| SECONDARY Systolic Blood Pressure |
4; 12 | — |
| SECONDARY Diastolic Blood Pressure |
2; 7 | — |
| SECONDARY Heart Rate |
3; 1 | — |
| SECONDARY Diabetes Treatment Satisfaction |
3.8; 4.9 | — |
| SECONDARY Hypoglycemia Fear |
0; 2.5 | — |
| SECONDARY Cholesterol |
0.4; 0.2 | — |
| SECONDARY HDL |
0.6; 0.03 | — |
| SECONDARY LDL |
0.2; 0.2 | — |
| SECONDARY Triglycerides |
0.0; 0.1 | — |
| SECONDARY Free Fatty Acids |
— | — |
| SECONDARY Sodium |
0; 1 | — |
| SECONDARY Potassium |
0.2; 0.1 | — |
| SECONDARY Creatinine |
2; 2 | — |
| SECONDARY Urate |
— | — |
| SECONDARY Albumin |
1; 0 | — |
| SECONDARY Hemoglobin |
0.3; 0.2 | — |
| SECONDARY Leucocytes |
0.1; 0.2 | — |
| SECONDARY Thrombocytes |
17; 6 | — |
| SECONDARY Iron |
2; 4 | — |
| SECONDARY Transferrin |
— | — |
| SECONDARY Ferritin |
— | — |
| SECONDARY Folate |
0.5; 0.3 | — |
| SECONDARY Vitamin B-12 |
18; 35 | — |
| SECONDARY Magnesium |
0.03; 0.02 | — |
| SECONDARY Zinc |
1; 0 | — |
| SECONDARY U-alb-crea Ratio |
1; 3 | — |
| SECONDARY Supar |
— | — |
| SECONDARY CRP |
— | — |
| SECONDARY IL-1 |
0.2; 0.9 | — |
| SECONDARY IL-6 |
1.8; 6.5 | — |
| SECONDARY IL-8 |
— | — |
| SECONDARY TNF-alpha |
2.3; 2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes ≥3 years
- Insulin pump use ≥1 year
- HbA1c ≥53 mmol/mol (7.0%)
- BMI 20-27 kg/m2
- Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
- Willingness to use continuous glucose monitoring consistently during the intervention periods
Exclusion Criteria
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Use of SGLT-2-inhibitors
- Use of corticosteroids during or within 30 days prior to the intervention periods
- Celiac disease
- Inflammatory bowel disease
- Macroalbuminuria
- Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
- Known or suspected alcohol or drug abuse
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Data sourced from ClinicalTrials.gov (NCT02888691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.