Clinical trial for Diabetes Mellitus, Type 1
Official title Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes
ClinicalTrials.gov ID: NCT05899166
What this study is testing
- What it's testing
- This study is testing whether a ketogenic diet helps control blood sugar. It also checks if this diet is safe for children.
- Who it's for
- You may be able to join if your child has just been diagnosed with type 1 diabetes.
- What's involved
- You would follow a special diet and get free meals and groceries. You would visit the clinic four times for blood tests and stool samples.
- Time commitment
- The main study lasts 9 months with four visits. You may be invited back after 24 months.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 12
You may be able to join if
- Children aged 5 to 12 years.
- Within 3 month of diabetes diagnosis.
- Insulin adjusted HbA1c ≤9 if enrolled ≥ 2 months pat diagnosis.
- Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker [glutamate decarboxylase-65...
- Family committed and able to participate in study education and implement dietary intervention.
You likely can't join if
- Dietary needs or habits incompatible with the study meal plans, (e.g., vegan, major food intolerances/allergies, ketogenic).
- Eating disorders as assessed by Chede-Q8.
- Major medical illness or use of medications other than insulin that could interfere with metabolic or glycemic variables.
- Major psychiatric illness.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.