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Behavioural Intervention
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
66 Previous Clinical Trials
99,545 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,950 Total Patients Enrolled
JANET K SNELL-BERGEON, PhD, MPHPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
6,000 Total Patients Enrolled