← Back to Search

Artificial Pancreas System

Control IQ for Type 1 Diabetes

Q: What are the eligibility requirements for involvement in this trial?

This investigation is enrolling 30 diabetic individuals aged between 6 to 21. As a requirement, they must have had two A1c values of ≥ 10% in the last two years and one at enrolment, accompanied by an adult that can contact them during medical emergencies. Additionally, participants should possess public healthcare insurance coverage, not be using insulin pump therapy, and demonstrate the capacity to operate related devices as well as adhere to protocol requirements.

Q: Is this experimentation available to those aged 20 or older?

The parameters for this trial dictate that individuals aged 6 to 21 can participate. Subsequently, there are 219 studies catering to minors and 925 designed for geriatric patients available.

Q: Are there any available opportunities for individuals to partake in this clinical trial?

As per the information published on clinicaltrials.gov, this trial is currently in search of participants and it was initially posted on June 1st 2021 with its most recent update being September 1st 2022.

Q: How many participants have joined the research project thus far?

Affirmative, clinicaltrials.gov data reveals that the trial is open for recruitment and was first posted on June 1st 2021. The study has been updated as recently as September 1st 2022 and seeks to enrol 30 participants from a single site.

N/A

Waitlist Available

Led By Brynn Marks, MD, MSHPH

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test how well a hybrid closed loop system works to control blood sugar in underserved youths with poorly controlled Type 1 diabetes, compared to standard diabetes education and care.

Eligible Conditions

Type 1 Diabetes

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in CGM Time in Range (TIR)

Secondary outcome measures

Changes in CGM time in hyperglycemia (>180 mg/dL)

Changes in CGM time in hypoglycemia (<70 mg/dL)

Changes in coefficient of variation of mean glucose

+17 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm- HCL TherapyExperimental Treatment1 Intervention

Single arm study with all participants being treated with HCL for 6 months given the non-randomized interrupted time series study design.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control IQ

2021

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tandem Diabetes Care, Inc.Industry Sponsor

37 Previous Clinical Trials

5,672 Total Patients Enrolled

Children's National Research InstituteLead Sponsor

210 Previous Clinical Trials

207,742 Total Patients Enrolled

DexCom, Inc.Industry Sponsor

137 Previous Clinical Trials

29,835 Total Patients Enrolled

Frequently Asked Questions

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

What are the eligibility requirements for involvement in this trial?

"This investigation is enrolling 30 diabetic individuals aged between 6 to 21. As a requirement, they must have had two A1c values of ≥ 10% in the last two years and one at enrolment, accompanied by an adult that can contact them during medical emergencies. Additionally, participants should possess public healthcare insurance coverage, not be using insulin pump therapy, and demonstrate the capacity to operate related devices as well as adhere to protocol requirements."

Answered by AI

Is this experimentation available to those aged 20 or older?

"The parameters for this trial dictate that individuals aged 6 to 21 can participate. Subsequently, there are 219 studies catering to minors and 925 designed for geriatric patients available."

Answered by AI

Are there any available opportunities for individuals to partake in this clinical trial?

"As per the information published on clinicaltrials.gov, this trial is currently in search of participants and it was initially posted on June 1st 2021 with its most recent update being September 1st 2022."

Answered by AI

How many participants have joined the research project thus far?

"Affirmative, clinicaltrials.gov data reveals that the trial is open for recruitment and was first posted on June 1st 2021. The study has been updated as recently as September 1st 2022 and seeks to enrol 30 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hybrid Closed Loop in High Risk Youth With Type 1 Diabetes

Amanda Perkins 2021. "Hybrid Closed Loop in High Risk Youth With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04807374.