Weekly Basal Insulin - Allowing More Flexibility With Treating Type 1 Diabetes. (In the Greater Seattle Area.)

  • STATUS
    Recruiting
Updated on 8 October 2021
insulin
hemoglobin a1c
sugars
Accepts healthy volunteers

Summary

We are currently seeking volunteers who are diagnosed with Type 1 Diabetes and who are treating with multiple daily injections (basal and bolus insulin regimens) for the past 1 year.

This is a study of an investigational once weekly basal insulin. Participants will be assigned to one of two groups: half of all participants will take the investigational insulin once a week, the other half will take Insulin Degludec (Tresiba) administered by insulin pen. All participants would switch to Insulin Aspart (Novolog) administered by insulin pen.

Participants must be willing to check their blood sugars 4 times a day and record the data using an electronic-diary (cannot use CGM values). Participants must be willing to wear a Dexcom G6 continuous glucose monitor for the duration of the study, which will be unblinded so both participant and study staff will see blood glucose results. 

Description

Study Length: 59 weeks, 28 clinic visits, and 28 telephone appointments.

Target Age: 18+ years old.

Benefits: Participants will receive the following at no cost during the study: all of their insulin; study-related physical exams, EKG’s, an eye exam, lab work, use of the Dexcom G6 CGM, a glucose meter, test strips and other supplies.

Stipend: Participants completing the study will receive financial compensation of $2,100. 

Details
Condition Type 1, Diabetes Mellitus Types I and II, Diabetes Prevention, insulin, clinical research, clinical trials, Diabetes Mellitus, type 1 diabetes, patients, Diabetes (Pediatric), weekly basal insulin, Seattle, experience
Clinical Study IdentifierTX275345
Last Modified on8 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

MUST BE ABLE TO MAKE IN-PERSON CLINIC VISITS TO OUR SITE IN RENTON, WASHINGTON
Aged ≥18 years
Diagnosed with type 1 diabetes mellitus ≥ 1 year prior to the day of screening
Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) ≥ 1 year prior to the day of screening
HbA1c <10% at screening visit measured by central laboratory

Exclusion Criteria

Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screenings
Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
Must meet other eligibility criteria - please contact us for further details: 425-251-1720
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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