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Behavioural Intervention

Personalized treatment for Low Blood Sugar (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

MERIT Trial 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.Check my eligibility

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.See study design

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.

MERIT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucose time in range

Secondary outcome measures

Glucose standard deviation

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

Mean glucose (mg/dL) pre-exercise

+1 more

MERIT 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Leona M. and Harry B. Helmsley Charitable TrustOTHER

57 Previous Clinical Trials

93,736 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,376 Total Patients Enrolled

JANET K SNELL-BERGEON, PhD, MPHPrincipal InvestigatorUniversity of Colorado, Denver

1 Previous Clinical Trials

6,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a possibility for me to participate in this medical study?

"To be eligible for enrollment in this research study, individuals must exhibit hypoglycemia and fall within the age bracket of 18 to 45 years. The trial has capacity for approximately 150 participants."

Answered by AI

Is the clinical trial open to individuals younger than 60 years old?

"Eligible candidates for this study must be above 18 years old and below 45 years of age."

Answered by AI

How many individuals in total are enrolled as participants in this medical study?

"Indeed, the details on clinicaltrials.gov highlight that this medical trial is actively enrolling participants. The study was initially uploaded on March 15th, 2024 and last revised on February 29th, 2024. Recruitment aims to include 150 individuals from a single site."

Answered by AI

Is the enrollment for this research study currently open?

"As per the details on clinicaltrials.gov, this particular trial is presently in the recruitment phase. The initial posting of the study was documented on March 15th, 2024 and it underwent its most recent revision on February 29th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes

2024. "Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06297980.

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