Type 2 DiabetesAID-BITNCT06024928
Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes
A study of Type 2 Diabetes, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2024to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
Official title: Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study
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.
Read the 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
- Being tested
- Control-IQ use in Type 2 Diabetes under basal insulin injections
- Keywords
- Automated Insulin Delivery (AID), Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ), Basal Insulin Titration (BIT)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control-IQ use in Type 2 Diabetes under basal insulin injectionsDevice
Also called Tandem Diabetes Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Testing survey
Receiving feedback from the participants regarding system functionality.
Measured: 14 days
Percent Time in Range
The percent of time spent within glycemic range of 70 to 180 mg/mL.
Measured: 14 days
Secondary outcomes (6)
Percent Time Below Range
The percent of time spent below 70 mg/mL.
Measured: 14 days
Percent Time Above Range
The percent of time spent above 180 mg/mL.
Measured: 14 days
Percent Time in Tighter Range
The percent of time spent within glycemic range of 70 to 140 mg/mL.
Measured: 14 days
Percent Time Below Range (Hypoglycemia)
The percent of time spent below 54 mg/mL.
Measured: 14 days
Percent Time Above Range (Hyperglycemia)
The percent of time spent above 250 mg/mL.
Measured: 14 days
Mean glucose reading measured by Continuous Glucose Monitor (CGM)
Glucose variability measured by coefficient of variation.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start18 Jun 2024
- Primary completion12 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralf M Nass, University of Virginia
- Investigators
- Ralf Nass, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024928
- Sponsor's protocol ID
- 230316
- Other IDs
- 1R01DK133148
- Acronym
- AID-BIT
- Status last verified
- May 2026
- First submitted
- 29 Aug 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT06024928
- Acronym / sponsor ID
- AID-BIT / 230316
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Automated Insulin Delivery in the Basal Insulin Titration Phase | Experimental | Device: Control-IQ use in Type 2 Diabetes under basal insulin injectionsParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
- Currently pregnant or intent to become pregnant during the trial.
- Currently breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control-IQ use in Type 2 Diabetes under basal insulin injectionsAlso: Tandem Diabetes CareTesting 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. | Device | Automated Insulin Delivery in the Basal Insulin Titration Phase |
Primary outcome
System Testing survey
Time frame: 14 days
Receiving feedback from the participants regarding system functionality.
Percent Time in Range
Time frame: 14 days
The percent of time spent within glycemic range of 70 to 180 mg/mL.
6 secondary outcomes
Percent Time Below Range
Time frame: 14 days
Percent Time Above Range
Time frame: 14 days
Percent Time in Tighter Range
Time frame: 14 days
Percent Time Below Range (Hypoglycemia)
Time frame: 14 days
Percent Time Above Range (Hyperglycemia)
Time frame: 14 days
Mean glucose reading measured by Continuous Glucose Monitor (CGM)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Nass, MD principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 2 Diabetes, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Testing survey (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.