Closed Loop Systems + Education for Type 1 Diabetes

(CLEAR Trial)

Recruiting at 7 trial locations

Overseen By Venus Grella, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Glucocorticoids, Steroids

Disqualifiers: Cognitive dysfunction, Cancer, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

324 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on glucocorticoids (a type of steroid) or have certain medical conditions, it might affect your eligibility. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment HARPdoc Education, My HypoCOMPaSS Education, Omnipod 5 or Medtronic 780G for Type 1 Diabetes?

Research shows that closed-loop systems, like the Omnipod 5 and Medtronic 780G, can improve glucose control in people with type 1 diabetes, especially after an initial adjustment period. These systems help reduce the need for frequent clinical visits and can lead to better management of blood sugar levels. ^{1 2 3 4 5}

Is the closed-loop system safe for use in humans?

Research shows that closed-loop systems, like the CamAPS FX, have been used safely in very young children with type 1 diabetes, with regular follow-ups to monitor their condition. These systems are designed to manage insulin delivery effectively, and while they improve blood sugar control, they also require careful monitoring and adjustments, especially in children. ^{5 6 7 8 9}

What makes the HARPdoc Education treatment unique for type 1 diabetes?

HARPdoc Education is unique because it combines educational support with the use of closed-loop systems, which automatically adjust insulin delivery based on continuous glucose monitoring. This approach can reduce the need for frequent clinical input and help patients manage their diabetes more independently compared to traditional insulin regimens. ^{3 4 5 10 11}

Research Team

Vernon M Chinchilli, PhD

Principal Investigator

Penn State College of Medicine

Elizabeth R Seaquist, MD

Principal Investigator

University of Minnesota

Simon Heller, MD

Principal Investigator

University of Sheffield

Eligibility Criteria

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.

Inclusion Criteria

HbA1c < 10.5%

Random non-fasting C-peptide < 200 pmol/L

Gold Score or Clarke Score ≥ 4 (highly associated with IAH)

Exclusion Criteria

Hemoglobin < 10 g/dL

Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)

I do not have skin conditions that prevent wearing a CGM.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Initial Intervention

Participants are randomized to either Hybrid Closed Loop (HCL) or Usual Care plus My HypoCOMPaSS education. HCL non-naïve participants are randomized to optimized HCL or HCL plus My HypoCOMPaSS.

12 months

Regular monitoring visits

Second Intervention

Participants with non-responsive CRR at 12 months are randomized to a second intervention, including HARPdoc education or continuation of HCL.

12 months

4 visits for HARPdoc education

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of CRR and hypoglycemia awareness.

24 months

Regular follow-up visits

Treatment Details

Interventions

• HARPdoc Education
• My HypoCOMPaSS Education
• Omnipod 5 or Medtronic 780G

Trial Overview 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.

Participant Groups

Group I: current HCL user: HCL x 24 months Experimental Treatment 1 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 months Experimental Treatment 1 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 months Experimental Treatment 2 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 months Experimental Treatment 2 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 months Experimental Treatment 1 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 months Experimental Treatment 1 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 months Experimental Treatment 2 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 months Active Control 2 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 months Active Control 3 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 months Active Control 1 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 months Active Control 2 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

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

AdventHealth

Collaborator

Trials

118

Recruited

31,800+

University of Leicester

Collaborator

Trials

218

Recruited

17,750,000+

University of Melbourne

Collaborator

Trials

193

Recruited

1,287,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Jaeb Center for Health Research

Collaborator

Trials

162

Recruited

36,200+

University of Sheffield

Collaborator

Trials

200

Recruited

7,756,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Findings from Research

A virtual educational camp (vEC) significantly improved glucose control in children and adolescents with type 1 diabetes, with over 75% of participants achieving a target range of glucose levels after the camp.

The study, involving 43 participants aged 7-16 years, showed a notable increase in the percentage of time in the target glucose range from 64% to 76% and a decrease in HbA1c by 0.5%, all without any severe hypoglycemia or diabetic ketoacidosis events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a closed-loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: A prospective, multicentre, real-life study. Cherubini, V., Rabbone, I., Berioli, MG., et al.[2021]

The investigational advanced hybrid closed-loop system significantly reduced daytime hyperglycemia in adolescents and young adults with type 1 diabetes compared to the MiniMed 670G system, with a mean difference of -3.00% in time spent above 180 mg/dL (p<0.0001).

The advanced hybrid closed-loop system maintained a similar safety profile, showing no increase in severe hypoglycemic events compared to the 670G system, indicating it is a safe alternative for managing blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Bergenstal, RM., Nimri, R., Beck, RW., et al.[2022]

The use of the AndroidAPS automated insulin delivery system significantly improved glycemic control in young children with type 1 diabetes, with time in range increasing and HbA1c levels decreasing after switching from a sensor-augmented pump.

No severe hypoglycemia or diabetic ketoacidosis (DKA) events were reported during the use of AndroidAPS, indicating a safe profile, along with reported improvements in quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. Petruzelkova, L., Jiranova, P., Soupal, J., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a closed-loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: A prospective, multicentre, real-life study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A qualitative study exploring the expectations of people living with type 1 diabetes regarding prospective use of a hybrid closed-loop system. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

What Training, Support, and Resourcing Do Health Professionals Need to Support People Using a Closed-Loop System? A Qualitative Interview Study with Health Professionals Involved in the Closed Loop from Onset in Type 1 Diabetes (CLOuD) Trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Parents' experiences of using a hybrid closed-loop system (CamAPS FX) to care for a very young child with type 1 diabetes: Qualitative study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Benefits and Challenges of Current Closed-Loop Technologies in Children and Young People With Type 1 Diabetes. [2021]

8. Denmark pubmed.ncbi.nlm.nih.gov

Safe and effective use of a hybrid closed-loop system from diagnosis in children under 18 months with type 1 diabetes. [2022]

9. Denmark pubmed.ncbi.nlm.nih.gov

Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of Youth With Type 1 Diabetes Initiating Use of a Hybrid Closed-Loop System While Receiving a Behavioral Economics Intervention. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Day and Night Closed-Loop Control Using the Integrated Medtronic Hybrid Closed-Loop System in Type 1 Diabetes at Diabetes Camp. [2022]