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

NCT06024928 | Completed FDA Device

• 2 other identifiers: 2303161R01DK133148
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Automated Insulin Delivery (AID); Continuous Glucose Monitor (CGM); Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ); Basal Insulin Titration (BIT)

Outcome Measures

Primary Outcomes (2)

• System Testing survey

  Receiving feedback from the participants regarding system functionality.

  14 days

• Percent Time in Range

  The percent of time spent within glycemic range of 70 to 180 mg/mL.

  14 days

Secondary Outcomes (6)

• Percent Time Below Range

  14 days

• Percent Time Above Range

  14 days

• Percent Time in Tighter Range

  14 days

• Percent Time Below Range (Hypoglycemia)

  14 days

• Percent Time Above Range (Hyperglycemia)

  14 days

Study Arms (2)

Automated Insulin Delivery in the Basal Insulin Titration Phase

EXPERIMENTAL

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.

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

Standard Care with Study Continuous Glucose Monitor

NO 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.

Interventions

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

Also known as: Tandem Diabetes Care

Automated Insulin Delivery in the Basal Insulin Titration Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18.0 years old at time of consent.
• Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
• HbA1c ≥ 7.5%.
• Currently using an approved long-acting insulin for at least two months (e.g., insulin glargine, insulin degludec)
• If using a CGM, willingness to wear an additional study CGM during the duration of the study.
• Access to the internet and willingness to upload data during the study as needed.
• 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.
• 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).

You may not qualify if:

• 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).
• Currently being treated for a seizure disorder.
• 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:
• Inpatient psychiatric treatment in the past 6 months
• Presence of a known adrenal disorder
• Uncontrolled thyroid disease
• Currently pregnant or intent to become pregnant during the trial.
• Currently breastfeeding.
• Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
• History of hypoglycemia unawareness.
• 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.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ralf Nass, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a randomized controlled parallel design trial where participants will be randomized 1:1 to either a control group or an experimental group.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: June 18, 2024
• Primary Completion: December 12, 2025
• Study Completion: December 16, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after the primary publications of the study.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team.

Locations

US (1)