N/A
Completed N=6
Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes
Source: ClinicalTrials.gov NCT04082884 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Percentage of Time in Target Range of 70-180 mg/dL. — 49.64; 48.86; 60.78; 50.1 percent time spent 70 mg/dL - 180 mg/dL
Summary
This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time in Target Range of 70-180 mg/dL. |
49.64; 48.86; 60.78; 50.1 | — |
| SECONDARY Percentage of Time Spent > 180 mg/dL to 250 mg/dl |
25.7; 25.36; 21.94; 21.32 | — |
| SECONDARY Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values |
22.58; 21.36; 14.32; 24.95 | — |
| SECONDARY Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values |
1.22; 2.96; 2.26; 2.65 | — |
| SECONDARY Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values |
0.68; 1.46; 0.68; 1.15 | — |
| SECONDARY Total Daily Insulin Dose |
0.78; 0.82; 0.60; 0.69 | — |
| SECONDARY Average Sensor Glucose Level |
193; 186; 169; 193 | — |
Eligibility Criteria
Inclusion Criteria
- BMI 19-30 m2 for individuals at least 18 years old or BMI 10%
- Recent history of more than 1 of diabetic ketoacidosis (DKA) in the past 6 months
- Treatment with glucose-lowering drugs other than insulin
- Unstable psychiatric disorders, including eating disorders (DSM-V criteria)
- Weight loss medications within the last 6 months
- Females who are pregnant, lactating or planning to become pregnant in the next 6 months
- Another medical condition that precludes participation in the study
Data sourced from ClinicalTrials.gov (NCT04082884). 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.