Menstrual Cycle Management for Type 1 Diabetes

(MERIT Trial)

Overseen By JANET K SNELL-BERGEON, PhD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Oral contraceptives

Disqualifiers: Postmenopausal, Pregnant, Hysterectomy, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves examining the impact of hormonal birth control, it seems likely that you can continue using it if you are already doing so.

What data supports the effectiveness of the treatment Personalized modifications for managing the menstrual cycle in women with Type 1 Diabetes?

Research suggests that adjusting insulin therapy based on menstrual cycle-related changes in insulin sensitivity can help stabilize blood sugar levels in women with Type 1 Diabetes. Studies using simulations showed that considering these changes can reduce high blood sugar episodes during the second half of the menstrual cycle. ^{1 2 3 4 5}

Is the treatment for managing menstrual cycle changes in type 1 diabetes safe for humans?

The studies suggest that adjusting insulin therapy based on menstrual cycle changes can improve blood sugar control without increasing the risk of low blood sugar, indicating it is generally safe. ^{1 2 3 6 7}

How does the treatment for menstrual cycle management in type 1 diabetes differ from other treatments?

This treatment is unique because it involves personalized modifications to insulin therapy based on changes in insulin sensitivity throughout the menstrual cycle, which is not typically addressed in standard diabetes management. By adjusting insulin dosing according to menstrual cycle phases, it aims to improve glucose control specifically for women with type 1 diabetes. ^{1 2 4 5 8}

What is the purpose of this trial?

The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.

Research Team

JANET K SNELL-BERGEON, PhD, MPH

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for women with Type 1 Diabetes who experience changes in their blood sugar levels due to their menstrual cycle. They should be interested in trying personalized treatment adjustments based on hormonal fluctuations.

Inclusion Criteria

I am a woman aged 18-45 and have had type 1 diabetes for over a year.

I am a premenopausal woman with regular menstrual cycles or using birth control pills.

Exclusion Criteria

I am a woman who has gone through menopause.

Pregnant women

Women trying to become pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability

12 weeks

Intervention

Test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Personalized modifications

Trial Overview The study tests how adjusting insulin doses and food intake according to the menstrual cycle can help manage blood sugar levels in women with Type 1 Diabetes. It also looks at how these changes affect exercise response and overall well-being.

Participant Groups

Group I: Personalized treatment Experimental Treatment 1 Intervention

We will test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase, based on the three months of observational data collected.

Group II: Standard Care Active Control 1 Intervention

In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Findings from Research

Women with type 1 diabetes (T1D) experience significant variations in insulin sensitivity and glycemic levels throughout different phases of the menstrual cycle, as reported by 12 participants using automated insulin delivery systems.

Despite the benefits of automated insulin delivery, participants still needed to manually adjust their insulin therapy based on their menstrual cycle, indicating a gap in information and support from healthcare providers regarding female-specific health issues in T1D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability of Glycemic Outcomes and Insulin Requirements Throughout the Menstrual Cycle: A Qualitative Study on Women With Type 1 Diabetes Using an Open-Source Automated Insulin Delivery System. Mewes, D., Wäldchen, M., Knoll, C., et al.[2023]

In a study of 16 women with type 1 diabetes, insulin sensitivity was found to decrease during the luteal phase of the menstrual cycle, leading to poorer glucose control without adjustments in insulin delivery.

Using a simulation model, it was shown that incorporating knowledge of menstrual cycle-related insulin sensitivity changes into insulin dosing algorithms could stabilize glycemic control, suggesting that current technology could be improved for better management of diabetes in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin Replacement Across the Menstrual Cycle in Women with Type 1 Diabetes: An In Silico Assessment of the Need for Ad Hoc Technology. Diaz C, JL., Fabris, C., Breton, MD., et al.[2022]

Incorporating menstrual cycle information into insulin therapy for women with type 1 diabetes can significantly reduce hyperglycemic excursions during the luteal phase, where insulin sensitivity typically decreases.

Simulation results indicate that adjusting insulin therapy based on menstrual cycle variability does not lead to a significant increase in hypoglycemic events, suggesting a safer approach to managing blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling the variability of insulin sensitivity during the menstrual cycle in women with type 1 diabetes to adjust open-loop insulin therapy. Diaz C, JL., Cengiz, E., Breton, MD., et al.[2021]

Women with type 1 diabetes experience significantly more menstrual problems, such as long cycles and heavy menstruation, before age 30 compared to their sisters and unrelated controls, indicating that type 1 diabetes is an independent risk factor for these disturbances.

The study found that oral contraceptives can help protect against menstrual issues in women with type 1 diabetes, particularly in their 30s, suggesting a potential management strategy for improving menstrual health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual cycle differences between women with type 1 diabetes and women without diabetes. Strotmeyer, ES., Steenkiste, AR., Foley, TP., et al.[2022]

This systematic review analyzed 14 studies on the relationship between the menstrual cycle and glucose control in type 1 diabetes, but found no conclusive evidence due to high variability in study methods and a high risk of bias.

Some evidence suggests that insulin sensitivity may worsen and hyperglycemia could increase during the luteal phase of the menstrual cycle, indicating the need for personalized management strategies for patients until more definitive research is available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual Cycle, Glucose Control and Insulin Sensitivity in Type 1 Diabetes: A Systematic Review. Gamarra, E., Trimboli, P.[2023]

In a study of 24,011 adolescent girls with type 1 diabetes, those using oral contraceptives (OC) exhibited a poorer cardiovascular risk profile, including higher rates of dyslipidemia (40.0% in OC users vs. 29.4% in non-users) and smoking (25.9% vs. 12.5%).

The findings suggest that OC use is associated with less favorable clinical characteristics and lifestyle factors, indicating that healthcare providers should screen for cardiovascular risks and provide education when prescribing OCs to this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral contraception in adolescents with type 1 diabetes and its association with cardiovascular risk factors. A multicenter DPV study on 24 011 patients from Germany, Austria or Luxembourg. Bohn, B., Mönkemöller, K., Hilgard, D., et al.[2019]

In adolescents with type 1 diabetes, both boys and girls showed improved glycemic control (HbA1c decrease) over two decades, with a notable convergence in HbA1c levels among those without a migrant background since 2016, indicating better management of diabetes in this group.

Insulin pump usage significantly increased among both sexes, with girls showing a higher adoption rate (54% vs. 47% for boys), and this increase in pump use was linked to improved HbA1c levels, particularly in adolescent girls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences over time for glycemic control, pump use and insulin dose in patients aged 10-40 years with type 1 diabetes: a diabetes registry study. Boettcher, C., Tittel, SR., Meissner, T., et al.[2022]

Postmenopausal women with type 1 diabetes require lower total daily insulin doses compared to premenopausal women, as shown in a study of 1,178 women using continuous insulin infusion.

Despite the lower insulin requirements, glycemic control and body mass index were similar between the two groups, suggesting that hormonal changes during menopause significantly impact insulin action and dosing needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in insulin dosing in women with type 1 diabetes before and after the menopause. Melmer, A., Zürrer, I., Kopp, F., et al.[2022]

References

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

Variability of Glycemic Outcomes and Insulin Requirements Throughout the Menstrual Cycle: A Qualitative Study on Women With Type 1 Diabetes Using an Open-Source Automated Insulin Delivery System. [2023]

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

Insulin Replacement Across the Menstrual Cycle in Women with Type 1 Diabetes: An In Silico Assessment of the Need for Ad Hoc Technology. [2022]

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

Modeling the variability of insulin sensitivity during the menstrual cycle in women with type 1 diabetes to adjust open-loop insulin therapy. [2021]

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

Menstrual cycle differences between women with type 1 diabetes and women without diabetes. [2022]

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

Menstrual Cycle, Glucose Control and Insulin Sensitivity in Type 1 Diabetes: A Systematic Review. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

Oral contraception in adolescents with type 1 diabetes and its association with cardiovascular risk factors. A multicenter DPV study on 24 011 patients from Germany, Austria or Luxembourg. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Sex differences over time for glycemic control, pump use and insulin dose in patients aged 10-40 years with type 1 diabetes: a diabetes registry study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Differences in insulin dosing in women with type 1 diabetes before and after the menopause. [2022]