Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes

NCT ID: NCT06024928

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-18
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

The study will involve 20 people with Type 2 Diabetes who are 18 years or older. The study will be performed at the University of Virginia (UVA), with screening procedures taking place either virtually or at the Clinical Research Unit (CRU) at UVA. All participants will undergo a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor (CGM). Participants will be randomized (1:1) to either the Control (CTR) Group or the Experimental (EXP) Group. In the EXP Group, participants will use an Automated Insulin Device (AID) for 10 days in the Basal Insulin Titration (BIT) Phase then return to their original therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP). The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose. During the same 10 days, in the CTR group, participants will use an unblinded CGM and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. Both groups will then go into a 10-days maintenance period using a blinded CGM. Outcomes will be measured in the last 7 days of the BIT and Maintenance Phases.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Automated Insulin Delivery in the Basal Insulin Titration Phase

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 Type: EXPERIMENTAL

Control-IQ use in Type 2 Diabetes under basal insulin injections

Intervention Type: DEVICE

Testing the safety and feasibility of using Automated Insulin Delivery (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration.

Standard Care with Study Continuous Glucose Monitor

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Control-IQ use in Type 2 Diabetes under basal insulin injections

Testing the safety and feasibility of using Automated Insulin Delivery (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration.

Intervention Type: DEVICE

Other Intervention Names

Tandem Diabetes Care

Eligibility Criteria

Inclusion Criteria

1. Age ≥18.0 years old at time of consent.

2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.

3. HbA1c ≥ 7.5%.

4. Currently using an approved long-acting insulin for at least two months (e.g., insulin glargine, insulin degludec)

5. If using a CGM, willingness to wear an additional study CGM during the duration of the study.

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

7. 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 who self-report that they are 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.

8. Willingness to remain on same dose of non-insulin glucose-lowering agent during the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals).

Exclusion Criteria

1. Currently using an approved intermediate (e.g., insulin NPH) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular).

2. Currently being treated for a seizure disorder.

3. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:

1. Inpatient psychiatric treatment in the past 6 months

2. Presence of a known adrenal disorder

3. Uncontrolled thyroid disease

4. Currently pregnant or intent to become pregnant during the trial.

5. Currently breastfeeding.

6. Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.

7. History of hypoglycemia unawareness.

8. On a non-stable dose of non-insulin glucose-lowering agent prior to the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals) as defined by study physician.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Anas El Fathi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anas El Fathi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Locations

VA Maryland Health Care System

Baltimore, Maryland, United States

Site Status: NOT_YET_RECRUITING

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lianna Smith

Role: CONTACT

lhs7px@uvahealth.org

434-243-6681

Carlene Alix

Role: CONTACT

uax8yx@uvahealth.org

434-249-8961

Facility Contacts

Lakshmi G Singh, PharmD, BCACP, CDCES

Role: primary

Lakshmi.Singh@va.gov

410-605-7000 ext. 56365

Jade N Churchill

Role: backup

Jade.Churchill@va.gov

410-605-7000

Ralf M Nass, MD

Role: primary

rmn9a@uvahealth.org

434-982-0868

Lianna H Smith

Role: backup

lhs7px@uvahealth.org

434-466-4856

Other Identifiers

1R01DK133148

Identifier Type: NIH

Identifier Source: secondary_id

View Link

230316

Identifier Type: -

Identifier Source: org_study_id