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Behavioral Intervention

current HCL user: HCL + My HypoCOMPaSS x 24 months for Type 1 Diabetes (CLEAR Trial)

N/A
Waitlist Available
Led By Vernon M Chinchilli, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months
Awards & highlights

CLEAR Trial Summary

This trial aims to see if avoiding low blood sugar episodes can help adults with type 1 diabetes who have trouble recognizing when their blood sugar is low. About 20-25% of adults with type

Who is the study for?
Adults with type 1 diabetes who often don't notice when their blood sugar gets too low can join this study. They should be interested in using new tech like the Omnipod 5 or Medtronic 780G insulin pumps and willing to learn through educational programs designed to help recognize low blood sugar symptoms.Check my eligibility
What is being tested?
The CLEAR study is testing whether special education programs (HARPdoc and My HypoCOMPaSS) combined with advanced insulin pumps (Omnipod 5 or Medtronic 780G) can help people better sense when their blood sugar drops, which is a common problem in long-term type 1 diabetes.See study design
What are the potential side effects?
Possible side effects may include skin irritation from the insulin pump, potential for incorrect insulin dosing leading to very high or low blood sugars, and stress due to constant monitoring of glucose levels.

CLEAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during the clamp studies at 0 (baseline), 12, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during the clamp studies at 0 (baseline), 12, and 24 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
Towler questionnaire
epinephrine (pg/ml)
Secondary outcome measures
% of time with sensor hypoglycemia <54 mg/dL
% of time with sensor hypoglycemia <70 mg/dL
% time with sensor glucose in range
+36 more

CLEAR Trial Design

11Treatment groups
Experimental Treatment
Active Control
Group I: current HCL user: HCL x 24 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 24-month period for individuals currently using a hybrid closed loop device
Group II: current HCL user: HCL x 12 months, then HCL x an additional 12 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
Group III: current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 monthsExperimental Treatment2 Interventions
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
Group IV: current HCL user: HCL + My HypoCOMPaSS x 24 monthsExperimental Treatment2 Interventions
Hybrid closed loop device plus My HypoCOMPaSS education over a 24-month period for individuals currently using a hybrid closed loop device
Group V: current HCL non-user: HCL x 24 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 24-month period for individuals currently not using a hybrid closed loop device
Group VI: current HCL non-user: HCL x 12 months, then HCL x an additional 12 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
Group VII: current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 monthsExperimental Treatment2 Interventions
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
Group VIII: current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 monthsActive Control2 Interventions
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device for 12 months
Group IX: current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 monthsActive Control3 Interventions
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device plus My HypoCOMPaSS eduction + HARPdoc education for 12 months
Group X: current HCL non-user: Usual Care and My HypoCOMPaSS x 24 monthsActive Control1 Intervention
Usual Care and My HypoCOMPaSS education over 24 months for individuals currently not using a hybrid closed loop device
Group XI: current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 monthsActive Control2 Interventions
Usual Care and My HypoCOMPaSS education over 12 months for individuals currently not using a hybrid closed loop device, then hybrid closed loop device for 12 months

Find a Location

Who is running the clinical trial?

AdventHealthOTHER
107 Previous Clinical Trials
29,255 Total Patients Enrolled
University of LeicesterOTHER
203 Previous Clinical Trials
17,750,438 Total Patients Enrolled
University of MelbourneOTHER
167 Previous Clinical Trials
1,287,976 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 criteria for individuals interested in participating in this research project?

"To be eligible for participation, individuals must have been diagnosed with type 1 diabetes and fall within the age range of 18 to 75 years. Approximately 324 participants are being sought for enrollment in this research study."

Answered by AI

Is this research including individuals who are older than 45 years of age?

"Participants between 18 and 75 years old are eligible for enrollment in this study. There are a total of 169 trials catering to those under 18, while there are 210 studies focused on the elderly population above 65 years of age."

Answered by AI

At how many different sites is this study currently being managed?

"There are 8 slots open for participation in this research endeavor, with established centers such as AdventHealth in Orlando, the University of Pennsylvania in Philadelphia, and the University of Kentucky in Lexington being among them. Additionally, there are openings at 5 other undisclosed locations."

Answered by AI

What are the projected results that researchers hope to achieve with this investigation?

"The main aim of this research, to be assessed during clamp studies at 0 (baseline), 12, and 24 months time points, is the Towler questionnaire. Additional outcomes encompass hospital stays (defined as instances requiring hospitalization), HbA1c levels (indicative of glycated hemoglobin content), and resting heart rate readings obtained via an activity monitor smartwatch."

Answered by AI

Are potential participants currently able to apply for this ongoing medical study?

"As per the details available on clinicaltrials.gov, recruitment for this particular trial is currently closed. The initial posting date was 1st July 2024 with the most recent update noted on 15th March 2024. Despite this trial not actively enrolling participants, it's noteworthy that there are a total of 425 ongoing studies seeking candidates at present."

Answered by AI

Who else is applying?

What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have been a Type 1 Diabetic for 24 years and I am constantly looking for the newest and most efficient way to help me lead a normal healthy life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Closed Loop and Education for Hypoglycemia Awareness Restoration
Vernon Michael Chinchilli 2024. "Closed Loop and Education for Hypoglycemia Awareness Restoration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06325202.
All > Hypoglycemia > Type 1 Diabetes
~216 spots leftby Jun 2027
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