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

Trial Summary

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 data supports the effectiveness of the treatment Carbohydrate counting, Carb counting, Meal planning, Simple Meal Bolusing, Simple Meal Bolus Strategy, Simplified Meal Boluses for Type 1 Diabetes?

Research shows that carbohydrate counting helps people with Type 1 diabetes better control their blood sugar levels and improve their quality of life. Studies found that using carbohydrate counting with insulin pumps can significantly lower blood sugar levels over time. ^{1 2 3 4 5}

Is carbohydrate counting safe for people with diabetes?

Carbohydrate counting is a widely used meal planning approach for people with diabetes, especially type 1 diabetes, and is considered safe. It helps manage blood sugar levels by focusing on the amount of carbohydrates consumed, and it can be adapted for different insulin regimens, making it flexible and enjoyable for patients. ^{2 6 7 8 9}

How does the treatment 'Carbohydrate counting and Simple Meal Bolusing' differ from other treatments for Type 1 Diabetes?

Carbohydrate counting and Simple Meal Bolusing is unique because it focuses on counting carbohydrates to manage blood sugar levels, allowing for flexible meal planning and precise insulin dosing. This approach is particularly beneficial for those using insulin pumps or multiple daily injections, as it helps tailor insulin doses to individual meals, unlike traditional fixed-dose insulin regimens. ^{1 2 4 6 7}

What is the purpose of this trial?

The goal of this trial is to evaluate blood sugar control in patients with type 1 diabetes when using a simple meal bolus strategy (small, medium, large meals) compared to carbohydrate counting when on a hybrid closed loop system. The main question it aims to answer are: What is the blood sugar time in range when using simple meal boluses versus carbohydrate counting? Participants will: Use the simple meal bolus plan for 4 weeks. Do precise carbohydrate counting for 4 weeks. Provide their continuous glucose monitor and pump data Take surveys about the experience of meal bolusing during the study

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 (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]

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]

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]

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]

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]

References

1. Japan 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. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Insulin therapy and carbohydrate counting. [2011]

3. United States 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). [2021]

4. United States 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Carbohydrate Counting in Children and Adolescents with Type 1 Diabetes. [2023]

6. Brazil pubmed.ncbi.nlm.nih.gov

[Evaluation of how satisfactory is carbohydrate counting in patients with diabetes]. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2021]