← Back to Search

Behavioral Intervention

Closed Loop Systems + Education 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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured two weeks prior to each clamp study at 0 (baseline), 12, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Towler questionnaire

epinephrine (pg/ml)

Secondary study objectives

% of time with sensor hypoglycemia <54 mg/dL

% of time with sensor hypoglycemia <70 mg/dL

% time with sensor glucose in range

+36 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out