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 trial explores how an artificial pancreas, which includes an insulin pump and continuous glucose monitor, affects heart health in people with type 1 diabetes. Researchers aim to determine if better blood sugar control reduces inflammation and improves heart function. Participants will manage their diabetes using either a closed-loop artificial pancreas system or sensor-augmented pump (SAP) therapy. This study suits adults who have had type 1 diabetes for over a year and are currently on insulin therapy. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance diabetes management and heart health.

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.

What prior data suggests that artificial pancreas technology is safe for patients with type 1 diabetes?

Research has shown that the Tandem t:slim X2 with Control-IQ Technology is safe and effective. In a small study, young children with type 1 diabetes used this system without major safety issues, and it improved their blood sugar control. This system combines an insulin pump and a sensor to predict and manage blood sugar levels.

For Sensor Augmented Pump (SAP) therapy, studies have also demonstrated its safety and ability to improve blood sugar control compared to regular insulin treatments. Both technologies aim to manage type 1 diabetes more effectively.

In summary, various studies have proven both the Tandem t:slim X2 and SAP therapy safe for people with type 1 diabetes. They also enhance blood sugar control, which is crucial for managing the condition. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Type 1 diabetes because they offer innovative ways to manage blood sugar levels. The closed-loop artificial pancreas system, featuring the Tandem t:slim X2 insulin pump with Control-IQ Technology and the Dexcom G6 Continuous Glucose Monitor (CGM), automatically adjusts insulin delivery based on real-time glucose readings. This is a step forward from standard insulin pumps and multiple daily injections, which require manual adjustments. Meanwhile, the Sensor Augmented Pump (SAP) therapy combines a study-specific CGM with the participant's current insulin therapy, potentially enhancing the accuracy of glucose monitoring and insulin dosing. Both approaches aim to improve glucose control and quality of life for people with Type 1 diabetes.

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

Studies have shown that the Tandem t:slim X2 insulin pump with Control-IQ Technology, which participants in this trial may receive, helps people with type 1 diabetes manage their blood sugar more effectively. This system uses smart technology to automatically adjust insulin levels, keeping blood sugar within the target range more often. Research suggests that this can lead to better long-term health by lowering the risk of diabetes-related complications.

Another treatment option in this trial is sensor-augmented pump (SAP) therapy, which combines a continuous glucose monitor (CGM) with insulin delivery. This approach has proven effective in improving blood sugar control over time, helping users maintain their blood sugar in the desired range, which is crucial for preventing complications. Both technologies offer promising ways to manage type 1 diabetes more effectively. ^{2 6 7 8 9}

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12183835/

Effectiveness and safety of AI-driven closed-loop systems ... AI-based closed-loop systems can analyze glucose data in real-time and automatically adjust insulin delivery, resulting in reduced time outside target glucose ...

2. diabetesjournals.org diabetesjournals.org/care/article/45/2/381/139011/Closed-Loop-Insulin-Delivery-Versus-Sensor

Closed-Loop Insulin Delivery Versus Sensor-Augmented ... Recently, a single-arm study of 15 older adults with type 1 diabetes showed more favorable glucose metrics during 4 weeks of using closed-loop ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S221462372200014X

Long-term efficacy of sensor-augmented pump therapy ... Long-term real-life treatment with the SAP-PLGM therapy combined with telemedicine was associated with improved glycemic control in T1D, along with high ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1002853

Effectiveness of Sensor-Augmented Insulin-Pump Therapy ... Improved glycemic control can reduce the microvascular and macrovascular complications associated with type 1 diabetes mellitus, and diabetes ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9207329/

Closed-Loop Insulin Delivery Systems: Past, Present, and ... in 2010 found that use of a fully closed-loop system in adults with type 1 diabetes improved hypoglycemia and time in target range compared to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3696941/

Routine Sensor-Augmented Pump Therapy in Type 1 Diabetes Sensor-augmented pump (SAP) therapy can improve glycemic control, compared with multiple daily insulin injections or with insulin pump therapy alone.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03784027

The Artificial Pancreas in Very Young Children With T1D This outcome study aims to determine whether 24/7 automated closed loop glucose control improves time in range compared to sensor augmented pump therapy.

8. adameetingnews.org adameetingnews.org/studies-provide-long-term-safety-efficacy-data-for-artificial-pancreas-use/

Studies provide long-term safety, efficacy data for artificial ... Study results presented Sunday at the Scientific Sessions demonstrating the safety and efficacy of artificial pancreas systems for insulin ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422791/

Results from the International Diabetes Closed-Loop Trial 4 Adults (≥18 years of age) with type 1 diabetes were randomized to either sensor-augmented pump (SAP) (inclusive of predictive low-glucose suspend) or adaptive ...