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Very Low Carbohydrate Diet for Type 1 Diabetes

N/A
Recruiting
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)
Age 18 to 40 years
Must not have
Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 1, 2, 4, 6, 9, 12
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the feasibility of a very low carbohydrate diet to help control type 1 diabetes.

Who is the study for?
Adults and adolescents aged 18-40 with Type 1 Diabetes, using an insulin pump and CGM, who have attended a diabetes care visit in the past year. They should not be on any restrictive diets or have conditions like celiac disease that affect diet.
What is being tested?
The trial is comparing the effects of a very low carbohydrate diet versus a standard one on blood sugar control in people with Type 1 Diabetes over 12 weeks. Participants will receive meal deliveries and undergo regular health checks including MRI scans.
What are the potential side effects?
Potential side effects may include changes in blood sugar levels leading to hypoglycemia or hyperglycemia due to dietary adjustments. The study also involves fasting blood draws and IV catheters which can cause discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have attended a diabetes care appointment in the last year.
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I am between 18 and 40 years old.
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I have had Type 1 Diabetes for at least one year.
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My physical development is at an advanced stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had severe low blood sugar or ketoacidosis in the last 6 months.
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I am not on medication that affects my metabolism or blood sugar, except for insulin or metformin.
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I have anemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 1, 2, 4, 6, 9, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 1, 2, 4, 6, 9, 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemoglobin A1C change
Secondary study objectives
Becks Depression Inventory II (BDI II) less suicidality
Glycemic Variability Index, a measure for glycemic variability normalized to mean blood glucose level
Highly Processed Food Withdrawal Scale (ProWS)
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: very low carbohydrate dietExperimental Treatment1 Intervention
Dietary Intervention, food delivery
Group II: standard dietActive Control1 Intervention
Dietary Intervention, food delivery

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,915 Total Patients Enrolled

Media Library

Standard Carbohydrate Diet Clinical Trial Eligibility Overview. Trial Name: NCT03710928 — N/A
Type 1 Diabetes Research Study Groups: very low carbohydrate diet, standard diet
Type 1 Diabetes Clinical Trial 2023: Standard Carbohydrate Diet Highlights & Side Effects. Trial Name: NCT03710928 — N/A
Standard Carbohydrate Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03710928 — N/A
~8 spots leftby Jul 2026
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