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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
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 moreAwards & 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
Find a Location
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