Automated Insulin Delivery for Type 2 Diabetes

(AID-BIT Trial)

Recruiting at 1 trial location

Overseen By Ralf Nass, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must be taking: Long-acting insulin

Must not be taking: Meglitinides, Sulfonylureas, Rapid insulin

Disqualifiers: Seizure disorder, Adrenal disorder, others

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

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing Type 2 Diabetes using an Automated Insulin Device. The goal is to determine if an insulin pump with Control-IQ Technology, which automates insulin delivery, can improve blood sugar control compared to usual insulin injections. Participants will either use this new pump for ten days or continue their regular insulin routine, and researchers will compare the results. This trial suits individuals who have had Type 2 Diabetes for over a year and are already using long-acting insulin. As an unphased trial, it offers participants the chance to contribute to innovative diabetes management research.

Will I have to stop taking my current medications?

You may need to stop using your personal continuous glucose monitor (CGM) during the study. You also cannot start any new non-insulin diabetes medications during the trial. If you are using certain types of insulin or medications like meglitinides or sulfonylureas, you may not be eligible to participate.

What prior data suggests that this Automated Insulin Device is safe for people with Type 2 Diabetes?

Research has shown that the Control-IQ Automated Insulin Delivery (AID) system is generally safe for people with type 2 diabetes. One study found that 30 adults using the system experienced better blood sugar control without an increase in low blood sugar episodes. Another study reviewed data from over 9,000 users of the t:slim X2 insulin pump with Control-IQ technology and found ongoing improvements in blood sugar management with no major safety issues. Overall, these findings suggest that the Control-IQ system effectively manages diabetes and is well-tolerated without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Automated Insulin Delivery (AID) system for Type 2 Diabetes because it offers a smarter, more efficient way to manage insulin levels. Unlike the standard insulin therapy that requires manual injections and constant monitoring, this system automates insulin delivery, adjusting doses in real-time based on continuous glucose monitoring. This could lead to more precise insulin management and potentially improve glucose control without the need for frequent finger pricks or insulin adjustments. Additionally, it simplifies the daily routine for people with Type 2 Diabetes, which can be a significant improvement over current methods.

What evidence suggests that this Automated Insulin Device is effective for Type 2 Diabetes?

Research has shown that the Control-IQ system, which automatically delivers insulin, can significantly aid in managing type 2 diabetes. In this trial, one group of participants will use Automated Insulin Delivery (AID) with the Control-IQ system during the Basal Insulin Titration Phase. One study found that adults using this system achieved much better blood sugar levels without an increased risk of low blood sugar. Another study discovered that Control-IQ users had improved blood sugar control and spent more time within a healthy range. Additionally, a large real-world study involving thousands of users demonstrated ongoing improvements in blood sugar management. These findings suggest that Control-IQ technology can be a valuable tool for people with type 2 diabetes to maintain better blood sugar control. ^{3 4 6 7 8}

Who Is on the Research Team?

Anas El Fathi, PhD

Principal Investigator

University of Virginia Center for Diabetes Technology

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 Diabetes, diagnosed for at least a year and currently on long-acting insulin like glargine or degludec. They should have an HbA1c level of at least 7.5% and not be using any rapid or intermediate insulins. Women must use contraception if applicable, and participants can't start new diabetes medications during the study.

Inclusion Criteria

Access to the internet and willingness to upload data during the study as needed

I have been diagnosed with type 2 diabetes for at least a year.

I have been using a long-acting insulin like glargine or degludec for over six months.

Exclusion Criteria

I am currently taking medication for diabetes.

I have been using a specific type of insulin for at least six months.

You have a medical condition that might make it difficult for you to finish the study, such as recent psychiatric treatment, adrenal disorder, or uncontrolled thyroid disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or in-person)

Run-in

Participants undergo a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor (CGM)

10 days

Basal Insulin Titration (BIT)

Participants in the experimental group use an Automated Insulin Device (AID) for 10 days to titrate basal insulin. Control group uses unblinded CGM with standard care adjustments.

10 days

Maintenance

Both groups transition to a 10-day maintenance period using a blinded CGM, maintaining the basal insulin dose.

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control-IQ

Trial Overview The trial tests an Automated Insulin Device (AID) with Control-IQ Technology in people taking basal insulin injections for Type 2 Diabetes. Participants are randomly placed into two groups: one uses the AID for ten days while the other does not, to compare how well each group controls their blood sugar levels.

How Is the Trial Designed?

Group I: Automated Insulin Delivery in the Basal Insulin Titration Phase Experimental Treatment 1 Intervention

Participants will use Automated Insulin Delivery (AID) for 10 days in the Basal Insulin Titration (BIT) Phase. This group will then return to their original home therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP) with a blinded CGM. The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.

Group II: Standard Care with Study Continuous Glucose Monitor Active Control 1 Intervention

Participants will use a study Continuous Glucose Monitor (CGM) along with their original home therapy and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. This group will then transition into a 10-day Maintenance Phase (MP) using a blinded CGM, where the basal dose will be maintained.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a 6-month trial with 168 patients, a closed-loop insulin delivery system significantly increased the percentage of time blood glucose levels were within the target range (70-180 mg/dL) by 11 percentage points compared to a sensor-augmented pump, demonstrating improved glycemic control.

The closed-loop system also resulted in a lower mean glycated hemoglobin level and reduced time spent with low blood glucose levels, with no serious hypoglycemic events reported, indicating a safe and effective option for managing type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. Brown, SA., Kovatchev, BP., Raghinaru, D., et al.[2022]

In a study involving 60 type 1 diabetic patients using continuous subcutaneous insulin infusion (CSII) and real-time continuous glucose monitoring (RT-CGM), the use of an algorithm in the first 16 weeks led to a significant reduction in A1C levels, with more patients achieving A1C levels of 7% or lower compared to those without the algorithm.

However, the algorithm did not increase the time spent in the target glucose range, and once RT-CGM was discontinued, A1C levels returned to baseline, indicating the importance of continuous monitoring for maintaining glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an algorithm to guide patients with type 1 diabetes treated with continuous subcutaneous insulin infusion on how to respond to real-time continuous glucose levels: a randomized controlled trial. Jenkins, AJ., Krishnamurthy, B., Best, JD., et al.[2022]

The Control-IQ closed-loop control (CLC) system significantly improved glycemic control in children with type 1 diabetes, increasing the mean percentage of time in range (TIR) from 55% to 65% after switching from sensor-augmented pump therapy, with 36% of participants achieving TIR >70%.

No severe hypoglycemia or diabetic ketoacidosis episodes were reported, indicating that the CLC system is a safe option for managing blood sugar levels in children aged 6-13 years over a 28-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes. Kanapka, LG., Wadwa, RP., Breton, MD., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11829226/

Automated Insulin Delivery in Adults With Type 2 Diabetes Primary outcome was change in HbA1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with ...

2. diabetes.org diabetes.org/newsroom/press-releases/breakthrough-studies-automated-insulin-delivery-and-cgm-type-2-diabetes

Breakthrough Studies on Automated Insulin Delivery and ... Findings from a new study demonstrate that CGM significantly enhances glycemic control in adults with type 2 diabetes who are not using insulin.

3. nejm.org nejm.org/doi/full/10.1056/NEJMc2507995

A Randomized Trial of Automated Insulin Delivery in Type ... A real-world evaluation of data from 9451 users of the t:slim X2 insulin pump with Control-IQ technology (Tandem) showed a sustained improvement ...

4. diabetesjournals.org diabetesjournals.org/clinical/article/42/1/116/153543/Beneficial-Effects-of-Control-IQ-Automated-Insulin

Beneficial Effects of Control-IQ Automated Insulin Delivery in ... Thirty adults with type 2 diabetes using the Control-IQ system showed substantial glycemic improvement with no increase in hypoglycemia.

5. investor.tandemdiabetes.com investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-nejm-publication-positive-pivotal/

Tandem Diabetes Care Announces NEJM Publication of ... Results published in NEJM demonstrate significant improvements in time in range and hemoglobin A1c (A1C) in people with type 2 diabetes when using Control-IQ+ ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39951268/

Automated Insulin Delivery in Adults With Type 2 Diabetes In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830238

Automated Insulin Delivery in Adults With Type 2 Diabetes To determine the outcomes of AID in individuals with type 2 diabetes, this study evaluated the Omnipod 5 AID System in a multicenter, single-arm ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11954135/

Performance of an Automated Insulin Delivery System in ... In conclusion, the use of this AID system is associated with effective therapy outcomes, indicated by over 70% TIR, and appears to be safe, as demonstrated by a ...