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Procedure

Fully Closed Loop System for Type 1 Diabetes

N/A

Recruiting

Led By Gregory P Forlenza, MD

Research Sponsored by Gregory Forlenza

Eligibility Criteria Checklist

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

Must have

Age either 14-17, 18-25, or 26-60 years at time of consent

Currently using insulin for at least 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between second week of the control period and the one-week at home period

Awards & highlights

Study Summary

This trial will study the effects of a diabetes AIDANET on glycemic control for people with diabetes aged 14-60 and different levels of HbA1c, over 5 days at a hotel and 7 days at home.

Who is the study for?

This trial is for people aged 14-60 with Type 1 Diabetes, using an insulin pump and a Dexcom G6 CGM. They must have been diagnosed at least a year ago, not be pregnant or planning pregnancy, willing to use the study's FCL system and follow the protocol including hotel stays and remote monitoring.Check my eligibility

What is being tested?

The AIDANET system is being tested in this trial. Participants will either start with their usual care before switching to AIDANET or vice versa. The study includes a stay at a facility followed by home monitoring to compare glycemic control between usual care and the new system.See study design

What are the potential side effects?

While specific side effects are not listed for this device-based intervention, typical concerns may include skin irritation from device adhesives, potential inaccuracies leading to hypo- or hyperglycemia, and discomfort during wear.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 14 and 60 years old.

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I have been using insulin for at least 6 months.

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I am willing to change my insulin type as directed for the study.

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I am not pregnant or breastfeeding.

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I am willing to use the study's monitoring and treatment devices.

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I have been using an insulin pump for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between second week of the control period and the one-week at home period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between second week of the control period and the one-week at home period

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between second week of the control period and the one-week at home period for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Mean Sensor Glucose Value

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group BExperimental Treatment1 Intervention

Two-week control period after the use of the AIDANET system.

Group II: Group AExperimental Treatment1 Intervention

Two-week control period before the use of the AIDANET system.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaOTHER

754 Previous Clinical Trials

1,245,037 Total Patients Enrolled

Gregory ForlenzaLead Sponsor

University of California, San FranciscoOTHER

2,507 Previous Clinical Trials

15,238,539 Total Patients Enrolled

Frequently Asked Questions

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

Are there still slots open to participate in this research project?

"Yes, the trial is still recruiting. As evidenced on clinicaltrials.gov this study was initially posted on November 1st 2023 and subsequently revised 8 days later."

Answered by AI

Does this research project admit volitioners of more advanced age?

"The necessary conditions for this medical trial necessitate that participants are between 14 and 60 years old. Subsequently, there are 168 trials available to minors and another 195 trails suitable for geriatric patients."

Answered by AI

What is the participant capacity of this clinical experiment?

"Affirmative. According to the information accessible on clinicaltrials.gov, this trial has been initiated and was last updated on November 8th 2023. 36 participants are being sought across 3 locations for participation in the research study which began on November 1st 23rd."

Answered by AI

Who meets the eligibility criteria for enrollment in this research project?

"This clinical trial is recruiting 36 individuals with type 1 diabetes aged between 14 and 60. Eligible applicants must meet the following criteria: age falls within either 14-17, 18-25, or 26-60 years at time of consent; live with a guardian knowledgeable about emergency procedures for hypoglycemia who can contact study staff in the event of an emergency; use a commercially approved insulin (e.g., lispro or aspart) that is compatible with their pump system over the duration of the study; have not been pregnant or breastfeeding during enrollment period; have had T1D diagnosis for more than one year prior to participating"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fully Closed Loop at Home (FCL@Home)

Gregory Forlenza 2023. "Fully Closed Loop at Home (FCL@Home)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041971.