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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how women's menstrual cycles and the use of hormonal birth control affect blood sugar control in those with type 1 diabetes. It tests personalized adjustments to insulin doses and food intake to better manage blood sugar levels during different phases of the menstrual cycle. Participants will be divided into two groups: one will continue their usual diabetes care, while the other will try personalized modifications. Women aged 18-45 with type 1 diabetes for at least a year, who still have menstrual cycles or use birth control pills, may be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to personalized diabetes care strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that scientists are exploring how to safely and effectively adjust type 1 diabetes management during the menstrual cycle. Although data remains limited, the goal is to tailor insulin doses and food intake according to the menstrual cycle, potentially improving blood sugar control.

Current studies do not yet provide specific details about side effects or safety, but the aim is to enhance diabetes management without causing harm. As this trial is not in a specific phase, the approach is still under exploration, and detailed safety information may be limited. However, this personalized method intends to be safe and to improve the quality of life for women with type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized treatment for managing Type 1 Diabetes during the menstrual cycle because it offers a tailored approach unlike the typical standard care. While most treatments involve a consistent insulin regimen regardless of menstrual changes, this method adjusts insulin doses, food intake, and glycemic algorithms based on the individual's menstrual cycle phase. By personalizing these variables, the treatment aims to optimize blood sugar control during different hormonal phases, potentially reducing fluctuations and improving overall diabetes management for women.

What evidence suggests that this trial's treatments could be effective for managing type 1 diabetes during the menstrual cycle?

Research has shown that adjusting insulin doses based on menstrual cycle changes can help women with type 1 diabetes manage their blood sugar more effectively. Studies have found that these adjustments do not increase the risk of low blood sugar. A review of research highlighted how the menstrual cycle affects blood sugar levels and the body's response to insulin, suggesting that personalized treatment could be beneficial. In this trial, participants in the personalized treatment arm will receive up to four personalized adjustments to food intake, insulin dose, and glycemic algorithms according to menstrual cycle phase. Participants in related studies reported feeling more comfortable and safe when their insulin therapy was adjusted according to their cycle. Overall, early findings suggest that personalized changes during different menstrual phases might lead to better diabetes management. ^{1 2 5 6 7}

Who Is on the Research Team?

JANET K SNELL-BERGEON, PhD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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

Pregnant women

Women trying to become pregnant

I have had a hysterectomy.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-2-2024-55179

Menstrual Cycle Management for Type 1 Diabetes The studies suggest that adjusting insulin therapy based on menstrual cycle changes can improve blood sugar control without increasing the risk of low blood ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9962060/

Menstrual Cycle, Glucose Control and Insulin Sensitivity in ... The aim of this systematic review is to reveal more solid information about the impact of the menstrual cycle on glycaemic outcomes and insulin sensitivity in ...

3. breakthrought1d.org breakthrought1d.org/grants/switzerland/bern/fighting-fake-carbs-with-science/

Fighting fake carbs with science The TIMES study aims to understand how insulin needs and blood sugar control change throughout the menstrual cycle in women with type 1 diabetes. We want to ...

4. mdpi.com mdpi.com/2673-4540/6/11/139

Effect of Menstrual Cycle on Glycemic Outcomes and ... Methods: This study is a prospective analysis of a cohort of premenopausal women with T1D with spontaneous menstrual cycles who are users of an AHCL system 780G ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/19322968221080199

Variability of Glycemic Outcomes and Insulin Requirements ... All participants reported increased comfort and safety since using AID, but were still required to manually adjust their therapy according to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10563528/

Variability of Glycemic Outcomes and Insulin Requirements ... This study highlights that scientific evidence, therapeutic options, and professional guidance on female health-related aspects in T1D are insufficient to date.

7. liebertpub.com liebertpub.com/doi/10.1089/dia.2024.0522

Glycemic Control Across the Menstrual Cycle in Women ... Conclusion: Our results suggest that differences in glycemic control may be found across the menstrual cycle in women with T1D using the MiniMed ...