Meal Strategies for Type 1 Diabetes

Overseen By Alexandra Sawyer, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Steroids

Disqualifiers: Severe hypoglycemia, DKA, Renal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

40 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 5 6 7 8}

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

I agree not to start any new non-insulin diabetes medications during the trial.

I am confident I can follow the study's procedures and use its devices correctly.

I have been diagnosed with Type 1 Diabetes for at least a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in Period

Participants undergo a 2-week run-in period of usual care to establish baseline data and adjust pump settings as needed

2 weeks

1 visit (in-person)

Treatment Phase 1

Participants use either the simple meal bolus plan or precise carbohydrate counting for 4 weeks

4 weeks

1 follow-up visit (in-person, virtual, or by phone)

Wash-out Period

Participants return to usual care for 1 week to wash out the effects of the first treatment phase

1 week

Treatment Phase 2

Participants switch to the opposite meal bolus strategy for another 4 weeks

4 weeks

1 final study visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbohydrate counting
• Simple Meal Bolusing

Trial Overview

The trial compares blood sugar control between two methods: simple meal bolusing (estimating small, medium, or large meals) versus precise carbohydrate counting over four weeks each while on a hybrid closed loop system.

How Is the Trial Designed?

Group I: Simple Meal Bolusing Experimental Treatment 1 Intervention

Participants will be instructed to enter a set number of carbohydrates before meals based on if they are having a small, medium, or large meal. The preset numbers for meals will be based on their average total daily dose (TDD) determined during the 2-week usual care observation period. The participants will have their insulin to carbohydrate ratios set based on the standard formula of 450/TDD for all meals initially (e.g. a child with a TDD of 50 u/day would have 450/50=9 so an I:C of 1:9). They enter a carbohydrate amount of 30 g for small meals, 60 g for regular meals, and 90 g for large meals.

Group II: Precise Carbohydrate counting Active Control 1 Intervention

Participants will be instructed to enter a precise carbohydrate count before meals to the best of their ability. Pump settings may be adjusted per provider discretion and typical clinical care during this time period.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

Consistent carbohydrate intake is crucial for improving blood glucose control in Type 1 diabetes, as it helps optimize insulin delivery from artificial pancreas systems.

Carbohydrate counting is an effective meal planning strategy that allows flexibility in food choices while focusing on the primary impact of carbohydrates on blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin therapy and carbohydrate counting. Chiesa, G., Piscopo, MA., Rigamonti, A., et al.[2011]

In a study of 22 type 1 diabetes patients over one year, those who used carbohydrate counting with bolus calculators showed a significant decrease in hemoglobin A1c levels, indicating better long-term glycemic control (P = 0.0297).

The group that did not use bolus calculators did not experience any change in their hemoglobin A1c levels, highlighting the importance of this method for effective insulin pump therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of carbohydrate counting using bolus calculators on glycemic control in type 1 diabetes patients during continuous subcutaneous insulin infusion. Yamada, E., Okada, S., Nakajima, Y., et al.[2021]

A novel insulin dosing algorithm based on the food insulin index (FII) significantly improved blood glucose control in adults with type 1 diabetes, reducing post-meal glucose spikes by 52% compared to traditional carbohydrate counting.

The FII algorithm also increased the time patients spent within the normal blood glucose range by 31%, without increasing the risk of hypoglycemia, suggesting it is a safe and effective alternative for insulin dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the estimation of mealtime insulin dose in adults with type 1 diabetes: the Normal Insulin Demand for Dose Adjustment (NIDDA) study. Bao, J., Gilbertson, HR., Gray, R., et al.[2021]

In a study of 61 adult patients with type 1 diabetes using continuous subcutaneous insulin infusion (CSII), carbohydrate counting improved quality of life and reduced body mass index (BMI) and waist circumference compared to traditional insulin dose estimation methods.

While there were no significant changes in overall glycemic control (HbA1c) in the intention-to-treat analysis, a per-protocol analysis showed a slight reduction in HbA1c levels, indicating that carbohydrate counting can be an effective strategy for managing diabetes in patients consistently using it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of carbohydrate counting on glucose control and quality of life over 24 weeks in adult patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized, prospective clinical trial (GIOCAR). Laurenzi, A., Bolla, AM., Panigoni, G., et al.[2021]

A study involving 50 patients with type 1 diabetes showed that over 80% of participants were satisfied with carbohydrate counting for meal planning, appreciating its flexibility in meal choices and social activities.

The majority of participants (60% to 80%) also felt positively about aspects like food type selection and managing sugar-rich foods, indicating that carbohydrate counting supports a better lifestyle for those on intensive insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of how satisfactory is carbohydrate counting in patients with diabetes]. Hissa, AS., Albuquerque, LL., Hissa, MN.[2019]

In a study involving 7 patients with type 1 diabetes, it was found that high-fat meals required significantly more insulin (12.6 units) compared to low-fat meals (9.0 units) for the same carbohydrate content, indicating that dietary fat impacts insulin needs.

Despite the increased insulin for high-fat meals, patients experienced more hyperglycemia, suggesting that current carbohydrate-only based insulin dosing guidelines may not be sufficient and highlighting the need for new algorithms that consider dietary fat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fat acutely increases glucose concentrations and insulin requirements in patients with type 1 diabetes: implications for carbohydrate-based bolus dose calculation and intensive diabetes management. Wolpert, HA., Atakov-Castillo, A., Smith, SA., et al.[2022]

Carbohydrate counting is a flexible meal planning method for children and adolescents with diabetes that helps manage blood sugar levels by focusing on carbohydrate intake, which is crucial for their growth and psychological development.

This approach allows for personalized insulin adjustments based on individual eating habits, making it suitable for various insulin regimens, including multiple daily injections and insulin pumps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of carbohydrate counting in the treatment of children with diabetes. Kawamura, T.[2022]

Carbohydrate counting (CC) can improve metabolic control in children and adolescents with type 1 diabetes (T1D), potentially lowering HbA1c levels and reducing hypoglycemia events.

CC allows for greater meal flexibility, helping young patients manage their diabetes more effectively without negatively impacting their body mass index, although further high-quality studies are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbohydrate Counting in Children and Adolescents with Type 1 Diabetes. Tascini, G., Berioli, MG., Cerquiglini, L., et al.[2023]

The paper presents six alternative meal-planning approaches for individuals with diabetes, emphasizing the importance of personalized nutrition education beyond traditional exchange lists.

These approaches, including High Carbohydrate-High Fiber Exchange System and Calorie/Fat Counting, are evaluated based on their effectiveness for weight loss, glucose control, and ease of learning, providing a comprehensive resource for tailored dietary management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternatives to the exchange system for teaching meal planning to persons with diabetes. Pastors, JG.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10726644/

The Impact of Using Carbohydrate Counting on Managing ...

The purpose of this narrative review is to evaluate the impact of CC in helping people with diabetes manage their condition. It reveals that CC ...

2.

nature.com

nature.com/articles/srep37067

Effectiveness of advanced carbohydrate counting in type 1 ...

Overall meta-analysis identified a significant decrease in HbA1c concentration with carbohydrate counting versus other diabetes diet method or ...

3.

diabetes.org

diabetes.org/food-nutrition/understanding-carbs/carb-counting-and-diabetes

How to Count Carbs for Diabetes

Carb counting at its most basic level involves counting the number of grams of carbohydrate in a meal and matching that to your dose of insulin.

4.

mdpi.com

mdpi.com/2072-6643/16/21/3745

Comparing the Effectiveness of Different Dietary ...

Despite its benefits, many individuals struggle with mastering carbohydrate counting, leading to inconsistent use and suboptimal glycemic outcomes.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0899900723003465

Basic carbohydrate counting and glycemia in young ...

The aim of this study was to evaluate the effect on glycemic control and acceptability of basic carbohydrate counting (BCC) in children and young adults with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11279647/

Assessing Carbohydrate Counting Accuracy

Carbohydrate counting (CC) is widely used by patients with type 1 diabetes to adjust prandial insulin bolus doses based on estimated ...

7.

diabetesjournals.org

diabetesjournals.org/care/article/48/8/e97/160531/AI-Powered-Carbohydrate-Counting-for-Type-1

AI-Powered Carbohydrate Counting for Type 1 Diabetes

When minimal data were provided, error rates were significantly lower for non-prepackaged meals (MAPE 25%) than for prepackaged meals (MAPE 44.6 ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0168822725000828

A scoping review exploring research investigating the ...

To evaluate evidence describing a potential association between carbohydrate counting (CC) in type 1 diabetes and eating behaviours and/or disordered eating ...