Menstrual Cycle Management for Type 1 Diabetes (MERIT Trial)

N/A

Recruiting

Led By JANET K SNELL-BERGEON, PhD, MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months during randomization to intervention or standard care

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study how sex hormones, such as those from hormonal birth control and menstrual cycle phases, affect blood sugar control in women with type 1 diabetes. The researchers will also test different insulin

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the trial involves personalizing existing treatments, side effects may vary but could include hypoglycemia or hyperglycemia due to insulin dose adjustments, as well as potential discomfort from monitoring devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months during randomization to intervention or standard care

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months during randomization to intervention or standard care

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months during randomization to intervention or standard care for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose time in range

Secondary study objectives

Glucose standard deviation

Mean glucose (mg/dL) over 24 hours after exercise

Mean glucose (mg/dL) pre-exercise

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personalized treatmentExperimental Treatment1 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 CareActive Control1 Intervention

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

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