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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people with type 1 diabetes better recognize and manage low blood sugar symptoms. It tests a combination of education and technology, such as hybrid closed loop systems, to determine if they can improve awareness and response to low blood sugar. The trial includes different groups: some participants use these devices for the first time, while others continue their current use, all combined with educational programs (HARPdoc Education or My HypoCOMPaSS Education) over varying time frames. It suits adults who have had type 1 diabetes for at least 10 years and struggle to recognize low blood sugar. As an unphased trial, it provides a unique opportunity to explore innovative solutions for managing low blood sugar symptoms.

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 prior data suggests that these closed loop systems and educational interventions are safe for individuals with type 1 diabetes?

Research shows that the treatments in this study, including hybrid closed loop (HCL) systems and the HARPdoc and My HypoCOMPaSS education programs, are generally safe.

For hybrid closed loop systems, studies have found they are safe and help control blood sugar levels in both adults and children with type 1 diabetes. Users report better diabetes management, and no major safety issues have emerged in these studies.

HARPdoc education has been tested on people with type 1 diabetes who have trouble recognizing low blood sugar symptoms. Research indicates it can reduce severe low blood sugar events without major side effects. Similarly, My HypoCOMPaSS education has successfully increased awareness of low blood sugar episodes and significantly reduced severe incidents.

These findings suggest the treatments are well-tolerated and have a low risk of serious side effects. However, individual responses can vary, so following healthcare professionals' advice is important when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Closed Loop Systems + Education for Type 1 Diabetes because it could redefine how we manage this condition. Traditional treatments often involve manual insulin injections and constant blood sugar monitoring, which can be burdensome for patients. This trial is exploring the use of hybrid closed loop (HCL) systems, which automatically adjust insulin delivery based on real-time glucose readings, significantly reducing the need for manual intervention. Additionally, the trial is testing the impact of education programs like HARPdoc and My HypoCOMPaSS, which aim to empower patients with the knowledge to better manage their condition. By combining advanced technology with comprehensive education, researchers hope to enhance quality of life and improve health outcomes for people with Type 1 Diabetes.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

Research has shown that the HARPdoc education program, available to participants in this trial, can reduce severe hypoglycemia, or dangerously low blood sugar, in adults with type 1 diabetes. This program is particularly beneficial for those who struggle to notice these episodes, as it improves their quality of life and boosts confidence in managing their condition. Similarly, the My HypoCOMPaSS education program, another option in this trial, has reduced severe hypoglycemia by 20 times, helping participants better recognize symptoms of low blood sugar. Additionally, hybrid closed loop (HCL) systems like Omnipod 5 and Medtronic 780G, also under study in this trial, have improved blood sugar control, with many users spending more time within their target blood sugar levels. Together, these treatments aim to enhance awareness and management of low blood sugar in people with type 1 diabetes. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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

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)

Hemoglobin < 10 g/dL

Abnormal thyroid function tests of clinical significance, as determined by PI

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8943518/

Characteristics of adults with type 1 diabetes and treatment ... Our data show that the HARPdoc trial successfully recruited a cohort of people with type 1 diabetes, IAH and recurrent SH that has persisted ...

2. nature.com nature.com/articles/s41467-022-29488-x

A parallel randomised controlled trial of the Hypoglycaemia ... We conclude that HARPdoc is not superior to BGAT in reducing severe hypoglycaemia in adults with T1D and problematic hypoglycaemia that has ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/72/Supplement_1/390-P/150153/390-P-Improving-Quality-of-Life-and-Self-Efficacy

390-P: Improving Quality of Life and Self-Efficacy through a ... We conclude that HARPdoc reduces previously treatment-resistant severe hypoglycaemia in adults with type 1 diabetes but also enhances quality of life.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9050729/

A parallel randomised controlled trial of the Hypoglycaemia ... Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02940873

Study Details | NCT02940873 | Hypoglycaemia Awareness ... This will be a group randomised trial of HARPdoc, a novel intervention for adults with type 1 diabetes (T1DM) and treatment-resistant impaired awareness of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06325202

Closed Loop and Education for Hypoglycemia Awareness ... The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) ...