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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 1, 2, 4, 6, 9, 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 0, 1, 2, 4, 6, 9, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 1, 2, 4, 6, 9, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemoglobin A1C change
Secondary outcome measures
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 moreTrial 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
761 Previous Clinical Trials
5,579,698 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar levels are under control and within a certain range.You have a serious mental health condition.I haven't had severe low blood sugar or ketoacidosis in the last 6 months.You smoke, use drugs for fun, or drink too much alcohol.You do intense exercise for more than 2 hours on at least 3 days each week.You are currently using an insulin pump.You are currently on a diet that restricts your food intake for weight loss or other reasons.I have attended a diabetes care appointment in the last year.You have a history of an eating disorder or are at risk for developing one, as determined by the Eating Disorders Diagnostic Scale (EDDS).I am not on medication that affects my metabolism or blood sugar, except for insulin or metformin.You have dietary restrictions or food allergies that don't match with the food being provided.I can have an MRI and don't use strong mental health meds, or can stop them for the MRI.I am between 18 and 40 years old.I have had Type 1 Diabetes for at least one year.My physical development is at an advanced stage.I have anemia.Your body mass index (BMI) is between 18.5 and 35.You are using a continuous glucose monitor (CGM).
Research Study Groups:
This trial has the following groups:- Group 1: very low carbohydrate diet
- Group 2: standard diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to enroll in this investigation?
"To qualify for this medical trial, applicants must meet the criteria of having type 1 diabetes mellitus and being between 18-40 years old. 32 individuals are expected to be accepted in total."
Answered by AI
What is the scope of the population sample being tested in this experiment?
"Affirmative. The information posted on clinicaltrials.gov reveals that this medical trial has opened its recruitment phase, which was first launched on the 3rd of January 2020 and updated most recently on the 4th of March 2022. A total of 32 patients are needed to be gathered from a single site."
Answered by AI
Is this research project actively seeking participants?
"Correct. Clinicaltrials.gov indicates that this medical investigation, which was originally advertised on the 3rd of January 2020 is still searching for volunteers to participate. As of now, one location needs 32 participants."
Answered by AI
Is this study accessible to minors?
"This medical experiment has a lower age limit of 18 and an upper age cap of 40."
Answered by AI
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