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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Type 1 diabetes diagnosed for at least 1 year
Using monophasic oral contraceptives
Must not have
Active proliferative retinopathy
Severe peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how well a continuous glucose monitor works for women with type 1 diabetes who are using oral contraceptives.
Who is the study for?
This trial is for women with type 1 diabetes who've had it for at least a year, live in Edmonton, have regular menstrual cycles, and use monophasic oral contraceptives. It's not for those with heart disease, severe nerve damage, recent insulin changes, high blood pressure, certain eye conditions, or on medications affecting blood sugar.
What is being tested?
The study tests how aerobic exercise affects glucose levels during different phases of the menstrual cycle in women with type 1 diabetes. Participants will do a monitored exercise session and wear a continuous glucose monitor during the last week of active pills and no pill/placebo phase.
What are the potential side effects?
While this study isn't testing a drug that has side effects like medication might have, participants may experience typical exercise-related responses such as fatigue or muscle soreness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 1 diabetes for over a year.
Select...
I am using monophasic birth control pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active eye condition where new blood vessels are growing abnormally.
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I have severe nerve pain or numbness in my hands or feet.
Select...
I am taking medication that affects my blood sugar levels, not including insulin.
Select...
I have a history of heart disease.
Select...
I do not have any injuries that prevent me from exercising.
Select...
I often have sudden low blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours, 12 hours, overnight (midnight to 6 am) and 24 hours post-exercise
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood glucose
Secondary study objectives
Interstitial glucose (continuous glucose monitoring)
coefficient of variation (CV)
frequency of hyperglycemia
+5 moreOther study objectives
Carbohydrate supplementation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment2 Interventions
All participants will be in a single study arm.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
940 Previous Clinical Trials
434,028 Total Patients Enrolled
Women and Children's Health Research Institute, CanadaOTHER
17 Previous Clinical Trials
24,885 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not changed my insulin plan in the last two months.I have an active eye condition where new blood vessels are growing abnormally.I have severe nerve pain or numbness in my hands or feet.Your HbA1c level is higher than 9.9%.You are using a device that automatically gives you insulin.I have been diagnosed with Type 1 diabetes for over a year.I am using monophasic birth control pills.I am taking medication that affects my blood sugar levels, not including insulin.You have regular menstrual periods.Your blood pressure is higher than 140 over 95.I have a history of heart disease.I do not have any injuries that prevent me from exercising.I often have sudden low blood sugar levels.
Research Study Groups:
This trial has the following groups:- Group 1: All participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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