Meal Strategies for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how well people with type 1 diabetes can control their blood sugar using two different meal strategies. Participants will compare a simple meal bolus method (estimating carbs as small, medium, or large meals) with precise carbohydrate counting, while using their current insulin pumps. The trial will track blood sugar levels to identify which method maintains them in the target range longer. Individuals who have had type 1 diabetes for over a year and are already using a hybrid closed-loop system (an insulin pump and continuous glucose monitor that work together) might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to understanding effective meal strategies for better blood sugar control.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not start any new non-insulin glucose-lowering medications during the trial.
What prior data suggests that these meal strategies are safe for managing type 1 diabetes?
Research has shown that people with type 1 diabetes often use carbohydrate counting to adjust insulin doses before meals. While effective, some find it difficult to maintain, leading to poor blood sugar control.
Early results suggest that another method, called simple meal bolusing, might help. This involves categorizing meals as small, medium, or large to determine insulin doses. Some studies indicate it can help maintain steady blood sugar levels. However, a few participants reported mild side effects, such as stomach issues, when using this method.
This trial is labeled as "Not Applicable" in phase, meaning the methods being tested, like carbohydrate counting and simple meal bolusing, are not new drugs or treatments. They are generally safe because they adjust current diabetes management techniques rather than introducing new medications.12345Why are researchers excited about this trial?
Researchers are excited about the Meal Strategies for Type 1 Diabetes trial because it explores innovative approaches to managing mealtime insulin dosing. Unlike traditional methods that rely on precise carbohydrate counting, this trial investigates a simpler technique called Simple Meal Bolusing. This method allows participants to use set carbohydrate amounts for small, medium, and large meals, which could make insulin dosing easier and more intuitive. By potentially reducing the burden of accurate carb counting, these strategies may offer a more user-friendly way to manage blood sugar levels, especially for children and families.
What evidence suggests that this trial's meal strategies could be effective for type 1 diabetes?
This trial will compare two meal strategies for managing type 1 diabetes: precise carbohydrate counting and simple meal bolusing. Studies have shown that carbohydrate counting can significantly lower HbA1c levels, a measure of long-term blood sugar control, compared to other dietary methods for diabetes. However, some individuals find it difficult to learn, leading to uneven blood sugar results. In contrast, research suggests that a simple meal bolus strategy, where meals are labeled as small, medium, or large with set carbohydrate amounts, helps prevent large blood sugar fluctuations. This method has been tested in adults with type 1 diabetes and found to maintain stable blood sugar levels. Both strategies aim to improve blood sugar control but operate differently. Participants in this trial will be assigned to one of these strategies to evaluate their effectiveness.25678
Are You a Good Fit for This Trial?
This trial is for adolescents with Type 1 Diabetes who have been diagnosed for at least a year and are using a hybrid closed loop system. They should not plan to use new non-insulin glucose-lowering drugs during the study and must be willing to follow all procedures.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Period
Participants undergo a 2-week run-in period of usual care to establish baseline data and adjust pump settings as needed
Treatment Phase 1
Participants use either the simple meal bolus plan or precise carbohydrate counting for 4 weeks
Wash-out Period
Participants return to usual care for 1 week to wash out the effects of the first treatment phase
Treatment Phase 2
Participants switch to the opposite meal bolus strategy for another 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carbohydrate counting
- Simple Meal Bolusing
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor