Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study

A study of Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology. Read more about this study

Who is it for?: Ages 14 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 19 Aug 2021to 20 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 14 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Adult and adolescent male and female subjects >age 14 years
Clinical diagnosis of Type 1 diabetes for at least one year
Experienced Control-IQ technology user for ≥3 months.
Use of Control-IQ technology in closed-loop at least 80% of the 2-week time period before screening.
Not pregnant or planning a pregnancy during the time period of the study
Using only Humalog U-100 or Novolog U-100 insulin

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ICR and ISF optimized per investigator judgement
CGM time in range (70-180 mg/dL) at least 50% on Control-IQ technology
Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
Willing to:
Share Dexcom G6 CGM data with study staff and Tandem
Share t:connect data with Tandem
Eat meals with known carbohydrate amounts
Take meal boluses as directed (use of different options as scheduled and instructed)
Follow study Glycemic Treatment Guidelines for hypo and hyperglycemia
Keep food and exercise diary
Set accurate sleep schedule on pump
Exercise while using exercise activity in Control-IQ technology at least twice weekly
Complete questionnaires before and after using investigational device
Sign an informed consent form
Willingness to use the Dexcom G6 app on their personal phone throughout the study, and share real time CGM information with a local contact and study staff
Availability of a local contact who has access to the study participant, knows their whereabouts, and agrees to be promptly available if contacted by study staff. If the subject lives alone, the local contact must live within 30 minutes and have access to the subject overnight.

Who cannot join

Diabetic ketoacidosis (DKA) in the past 6 months
Severe hypoglycemia (needing assistance) in the past 6 months
Inpatient psychiatric treatment in the past 6 months
History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or is unwilling to agree to abstain from illicit drugs throughout the study
History of heart, lung or kidney disease determined by the investigator to interfere with the study
Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with the study

Show all 15Show fewer

Use of long-acting insulin or any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than metformin
Use of Afrezza during the study period
Febrile illness within 3 days of the start of the study
Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
For subjects >50 years old or with diabetes duration >20 years who will be exercising as part of the 48 hour study, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
Significant chronic kidney disease (eGFR < 60) or hemodialysis
Significant liver disease
History of adrenal insufficiency
History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22904

Other trials in United States

About this study

Official title: A Control-IQ Technology 2.0 Feasibility Study in Adult and Adolescent Subjects

The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.

Read the detailed description

This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by a 48-hour supervised phase, followed by a 4-week at home study with sequential interventions (new feature use). Approximately 30 subjects, both male and female, aged 14 and up, will participate in the study, using new features each week with the t:slim X2 insulin pump with Control-IQ technology.

The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.

Conditions: Diabetes Mellitus, Type 1
Being tested: Control-IQ technology 2.0
Keywords: type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control-IQ technology 2.0Device
All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor

Study groups in NCT05014789
Study group	Role	What they receive
Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pump	Experimental	After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0. The first 5 subjects participated in a 48-hour supervised hotel phase before continuing in the outpatient setting. Receives: Device: Control-IQ technology 2.0

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Percent Time Less Than 54 mg/dL
CGM overall percent time less than 54 mg/dL, with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks
Severe Hypoglycemia
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment), with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks
Diabetic Ketoacidosis
Number of Diabetic Ketoacidosis events with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks

Secondary outcomes (6)

Percent Time <70 mg/dL
CGM percent time <70 mg/dL, with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-140 mg/dL
CGM percent time 70-140 mg/dL, with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-180 mg/dL
CGM percent time 70-180 mg/dL, with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >180 mg/dL
CGM percent time >180 mg/dL, with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >250 mg/dL
CGM percent time >250 mg/dL, with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks
Median of Mean Glucose (mg/dL)
Median of individual participants CGM Mean Glucose values (mg/dL), with different feature use of the pump each week.
Measured: Data collected over 1 week for each intervention, up to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202120 Dec 2021

First posted20 Aug 2021
Study start19 Aug 2021
Primary completion20 Dec 2021
Study completion20 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single arm, Single Center, Prospective Clinical Study
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05014789
Sponsor's protocol ID: G210146
Status last verified: May 2026
First submitted: 13 Aug 2021
Last updated: 24 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Control-IQ Technology 2.0 Feasibility Study in Adult and Adolescent Subjects
ClinicalTrials.gov ID: NCT05014789
Acronym / sponsor ID: G210146
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
Study start: 19 Aug 2021 (actual)
Primary completion: 20 Dec 2021 (actual)
Study completion: 20 Dec 2021 (actual)
First posted: 20 Aug 2021 (actual)
Results: Posted 1 Jun 2026

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 study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.

Detailed description

The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm, Single Center, Prospective Clinical Study

Arm	Type	Receives
Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pump	Experimental	Device: Control-IQ technology 2.0After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0. The first 5 subjects participated in a 48-hour supervised hotel phase before continuing in the outpatient setting.

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (22 listed)

Adult and adolescent male and female subjects >age 14 years
Clinical diagnosis of Type 1 diabetes for at least one year
Experienced Control-IQ technology user for ≥3 months.
Use of Control-IQ technology in closed-loop at least 80% of the 2-week time period before screening.
Not pregnant or planning a pregnancy during the time period of the study

Key exclusion criteria (15 listed)

Diabetic ketoacidosis (DKA) in the past 6 months
Severe hypoglycemia (needing assistance) in the past 6 months
Inpatient psychiatric treatment in the past 6 months
History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or is unwilling to agree to abstain from illicit drugs throughout the study
History of heart, lung or kidney disease determined by the investigator to interfere with the study

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 technology 2.0All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor	Device	Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pump

Primary outcome

Overall Percent Time Less Than 54 mg/dL
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
CGM overall percent time less than 54 mg/dL, with different feature use of the pump each week.
Severe Hypoglycemia
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment), with different feature use of the pump each week.
Diabetic Ketoacidosis
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Number of Diabetic Ketoacidosis events with different feature use of the pump each week.

6 secondary outcomes

Percent Time <70 mg/dL
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-140 mg/dL
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-180 mg/dL
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >180 mg/dL
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >250 mg/dL
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Median of Mean Glucose (mg/dL)
Time frame: Data collected over 1 week for each intervention, up to 5 weeks

Results and safety

Results posted to the registry on 1 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump	30	30

Primary outcome: Overall Percent Time Less Than 54 mg/dL

Time frame: Data collected over 1 week for each intervention, up to 5 weeks. Median (Inter-Quartile Range). Unit: percentage of time

Measure	Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump n = 30
Run-In Week with home pump	0.1 (0.0 to 0.5)
Week A (Lower Target, Auto-bolus on, no late meal bolus)	0.1 (0.0 to 0.3)
Week B (Lower Target, Auto-bolus off, no late meal bolus)	0.2 (0.0 to 0.4)
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)	0.2 (0.0 to 0.4)
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)	0.2 (0.0 to 0.6)

Primary outcome: Severe Hypoglycemia

Time frame: Data collected over 1 week for each intervention, up to 5 weeks. Median (Inter-Quartile Range). Unit: number of events

Measure	Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump n = 30
Run-In Week with home pump	0.0 (0.0 to 0.0)
Week A (Lower Target, Auto-bolus on, no late meal bolus)	0.0 (0.0 to 0.0)
Week B (Lower Target, Auto-bolus off, no late meal bolus)	0.0 (0.0 to 0.0)
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)	0.0 (0.0 to 0.0)
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)	0.0 (0.0 to 0.0)

Primary outcome: Diabetic Ketoacidosis

Time frame: Data collected over 1 week for each intervention, up to 5 weeks. Median (Inter-Quartile Range). Unit: number of events

Measure	Control-IQ 2.0 Technology on the t:Slim X2 Insulin Pump n = 30
Run-In Week with home pump	0 (0.0 to 0.0)
Week A (Lower Target, Auto-bolus on, no late meal bolus)	0.0 (0.0 to 0.0)
Week B (Lower Target, Auto-bolus off, no late meal bolus)	0.0 (0.0 to 0.0)
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)	0.0 (0.0 to 0.0)
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)	0.0 (0.0 to 0.0)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 weeks, inclusive of one week Run-In then four weeks using the system.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control-IQ Technology 2.0 on the Tandem t:Slim X2 Insulin Pump	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Jordan E Pinsker, MD study chair

Tandem Diabetes Care, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. 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 22 inclusion and 15 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 24 Jun 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?

Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Percent Time Less Than 54 mg/dL (time frame: Data collected over 1 week for each intervention, up to 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05014789.

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 24 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.