Automated Insulin Delivery for Type 2 Diabetes

(AID-BIT Trial)

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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical trial is to test the safety and feasibility of using an Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration. Participants will be randomized to either the control group or the experimental group. If in the experimental group, the participant will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days. Researchers will compare the glycemic control of the experimental group to the control group.

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.

Is the automated insulin delivery system, including Control-IQ, safe for humans?

The Control-IQ system, used in people with type 1 diabetes, showed lower rates of severe low blood sugar (hypoglycemia) and a dangerous condition called diabetic ketoacidosis compared to past data. This suggests it is generally safe for use in humans. ^{1 2 3 4 5}

How does automated insulin delivery for type 2 diabetes differ from other treatments?

Automated insulin delivery systems, typically used for type 1 diabetes, use technology to automatically adjust insulin levels based on real-time glucose monitoring, which can offer more precise control compared to traditional insulin injections or oral medications for type 2 diabetes. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Control-IQ for Type 2 Diabetes?

Research on automated insulin delivery systems, like Control-IQ, shows they improve glucose control and quality of life in people with Type 1 Diabetes, suggesting potential benefits for Type 2 Diabetes as well. ^{5 6 7 10 11}

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]

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]

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]

Citations

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

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. [2022]

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

Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Improved technology satisfaction and sleep quality with Medtronic MiniMed® Advanced Hybrid Closed-Loop delivery compared to predictive low glucose suspend in people with Type 1 Diabetes in a randomized crossover trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Predictors of time in target glucose range in real-world users of the MiniMed 780G system. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Switching from predictive low glucose suspend to advanced hybrid closed loop control: Effects on glucose control and patient reported outcomes. [2022]

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

Real-World Use of Control-IQ Technology is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study. [2023]

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

Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. [2022]

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

Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes. [2022]

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

Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. [2022]

10. United States 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. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Comparison of Control-IQ and open-source AndroidAPS automated insulin delivery systems in adults with type 1 diabetes: The CODIAC study. [2023]