Artificial Pancreas for Type 1 Diabetes

(WBH002 Trial)

Overseen By Lee Hartline, MEd

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must be taking: Insulin

Must not be taking: Glucocorticoids, Non-insulin glucose-lowering

Disqualifiers: Cardiac disease, Seizure disorder, Smoking, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will examine the potential cardiovascular effect(s) of artificial pancreas (AP) technology in patients with type 1 diabetes. AP technology is a system of devices that closely mimics the glucose-regulating function of a healthy human pancreas. It includes an insulin pump and a continuous glucose monitor (CGM). In this study, the investigators will research whether improvements in blood glucose levels and blood glucose variability will in turn decrease biomarkers of inflammation and endothelial dysfunction while improving cardiovascular function.

Will I have to stop taking my current medications?

The trial requires participants to stop using any personal continuous glucose monitor (CGM) and to use only lispro (Humalog) or aspart (Novolog) insulin during the study. Participants must not start any new non-insulin glucose-lowering agents during the trial.

Is the artificial pancreas system safe for humans?

The artificial pancreas system, including the Tandem t:slim X2 with Control-IQ technology, has been used safely in people with type 1 diabetes. Studies show high satisfaction with the device, improved quality of life, and effective blood sugar control, indicating it is generally safe for human use. ^{1 2 3 4 5}

What makes the Tandem t:slim X2 with Control-IQ Technology treatment unique for Type 1 Diabetes?

The Tandem t:slim X2 with Control-IQ Technology is unique because it is an advanced hybrid closed-loop system that automatically adjusts insulin delivery based on continuous glucose monitoring, improving blood sugar control and quality of life for people with Type 1 Diabetes. It features a Sleep Activity Mode for better overnight glycemic control and has been shown to enhance patient satisfaction and reduce the impact of diabetes on daily life. ^{1 2 4 5 6}

What data supports the effectiveness of the treatment Tandem t:slim X2 with Control-IQ Technology for Type 1 Diabetes?

Research shows that the Tandem t:slim X2 pump with Control-IQ technology helps people with Type 1 Diabetes maintain better blood sugar control, with users spending about 79% of the time in the recommended blood sugar range. Users also reported high satisfaction with the device, improved quality of life, and better sleep quality. ^{1 2 3 4 5}

Who Is on the Research Team?

William B Horton, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults aged 18-40 with type 1 diabetes, using insulin for at least six months, and not currently pregnant or planning to become pregnant. Participants must have a BMI of 18-30 kg/m2, controlled blood pressure, and agree to use specific glucose monitors and insulins during the study. Exclusions include severe hypoglycemia history, smoking within two years, certain heart conditions, uncontrolled hypertension, bleeding disorders or hypersensitivity to insulin.

Inclusion Criteria

I take at least 10 units of insulin daily.

If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued

Current use of a glucometer that is downloadable; or willingness to use a study glucometer

Exclusion Criteria

A medical condition or medication, which in the opinion of the investigator or designee, would put the participant or study at risk

You have had a bad reaction to regular insulin in the past, like a severe allergic reaction or swelling.

Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the closed-loop artificial pancreas group or the sensor augmented pump therapy group for 12 weeks

12 weeks

Visits at baseline, 3 weeks, 6 weeks, 9 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sensor augmented pump (SAP) therapy
• Tandem t:slim X2 with Control-IQ Technology

Trial Overview The study tests if an artificial pancreas system (Tandem t:slim X2 with Control-IQ Technology) can better regulate blood sugar levels in type 1 diabetics compared to standard sensor-augmented pump therapy. It will assess whether this technology reduces inflammation markers and improves cardiovascular health by mimicking a healthy pancreas's functions.

How Is the Trial Designed?

Group I: Sensor Augmented Pump (SAP) therapy Experimental Treatment 1 Intervention

Sensor augmented pump (SAP) therapy that includes the use of a study CGM and the participant's current insulin therapy (i.e., either insulin pump or multiple daily injections)

Group II: Closed-loop artificial pancreas (AP) Experimental Treatment 1 Intervention

FDA approved Tandem t:slim insulin pump with Control-IQ Technology and the Dexcom G6 CGM

Tandem t:slim X2 with Control-IQ Technology is already approved in United States for the following indications:

Approved in United States as Tandem t:slim X2 with Control-IQ Technology for:

• Type 1 diabetes management for individuals aged 2 and older

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

The introduction of the Tandem t:slim X2 insulin pump with Control-IQ technology significantly increased the time patients spent in their target glucose range from 49.5% to 63.3%, indicating improved glucose management.

Patients also experienced a reduction in time spent above range (from 46.8% to 34.9%) and below range (from 4.0% to 1.7%), along with a decrease in hemoglobin A1C levels, demonstrating the efficacy and safety of this automated insulin delivery system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Control-IQ Technology in a General Endocrine Clinic. Usoh, CO., Price, C., Johnson, CP., et al.[2023]

After one year of using Advanced Hybrid Closed Loop (AHCL) systems, both the Tandem Control-IQ and MiniMed 780G showed sustained improvements in glycemic control for patients with Type 1 Diabetes, maintaining benefits seen after one month.

The MiniMed 780G demonstrated superior performance compared to Tandem Control-IQ in key glycemic metrics, including Time in Range (TIR) and average glucose levels, indicating it may be more effective in helping patients meet recommended glycemic targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year follow-up comparison of two hybrid closed-loop systems in Italian children and adults with type 1 diabetes. Bassi, M., Patti, L., Silvestrini, I., et al.[2023]

In a study involving 1,435 participants with type 1 diabetes using the t:slim X2 insulin pump with Control-IQ technology, time in range (TIR) for blood glucose levels improved from 78.2% to 79.2% over a period of about 7 weeks, indicating effective glycemic control.

Participants reported high satisfaction with the device, noting benefits such as improved diabetes management, better sleep quality, and enhanced quality of life, highlighting the psychosocial advantages of using this advanced insulin delivery system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology. Pinsker, JE., Müller, L., Constantin, A., et al.[2023]

The HCLCheck-in program, which involved follow-up calls from diabetes educators two weeks after starting the Control-IQ hybrid closed-loop system, showed that 60% of participants met key benchmarks for effective diabetes management, indicating the program's potential to enhance user experience and outcomes.

For users who initially did not meet benchmarks, a second follow-up call led to a significant improvement in Time-in-Range (TIR) by 12.5%, demonstrating that early educator support can positively impact diabetes management in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initiating hybrid closed loop: A program evaluation of an educator-led Control-IQ follow-up at a large pediatric clinic. Messer, LH., Berget, C., Ernst, A., et al.[2022]

In a study of 83 young patients with Type 1 Diabetes, the use of the Sleep Activity Mode in the Tandem Control-IQ system did not result in better nighttime glycemic control compared to those who did not use it, with only a slight difference in time in range (TIR%).

Patients not using Sleep Mode who maintained high sensor and automatic mode usage (≥90%) achieved better nighttime TIR (>70%) and lower time above range (TAR), suggesting that the effectiveness of Sleep Mode may vary based on individual habits and circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To sleep or not to sleep: An Italian Control-IQ-uestion. Bassi, M., Strati, MF., Andreottola, V., et al.[2023]

The Control-IQ hybrid closed-loop artificial pancreas system significantly improved the time children with type 1 diabetes spent in the target glucose range (70-180 mg/dL) compared to sensor-augmented pump therapy, with an increase from 52.8% to 71.0%.

The Control-IQ system also lowered average glucose levels without increasing the risk of hypoglycemia, demonstrating its efficacy and safety for managing diabetes in school-aged children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial. Forlenza, GP., Ekhlaspour, L., Breton, M., et al.[2023]

Citations

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

Efficacy of Control-IQ Technology in a General Endocrine Clinic. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

One-year follow-up comparison of two hybrid closed-loop systems in Italian children and adults with type 1 diabetes. [2023]

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

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology. [2023]

4. Denmark pubmed.ncbi.nlm.nih.gov

Initiating hybrid closed loop: A program evaluation of an educator-led Control-IQ follow-up at a large pediatric clinic. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

To sleep or not to sleep: An Italian Control-IQ-uestion. [2023]

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

Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial. [2023]