Type 1 DiabetesNCT06717451
PS230005 Control-IQ 1.5 Post-Approval Study
An observational study of Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 1 site in United States.
Trial summary
This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to <6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to 10 Aug 2026
- Phase
- Observational
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Enrollment in the study will be available to all individuals age 2 to <6 years of age at time of screening who start therapy with Control-IQ Technology v1.5.
Who may be able to join
- Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump
- Age 2 to <6 years at time of screening
- Using an insulin approved for use in the pump
- Using an iCGM sensor approved for use with the pump
- Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.
- Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
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- Ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.
- Reside full-time in the United States.
- Willingness to download the t:connect Mobile application to their smartphone and keep it active throughout the study if using a Tandem t:slim X2 pump. Participants who are unable to use the t:connect mobile application must be willing to manually upload their insulin pump data to Tandem Source every three months and at the completion of the study.
- Participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).
Who cannot join
- Use of any glucose-lowering therapy other than insulin.
- A medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to <6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.
Read the detailed description
The study will recruit participants age 2 to <6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.
- Conditions
- Type 1 Diabetes
- Being tested
- Control-IQ Technology v1.5
- Keywords
- type 1 diabetes, Control-IQ, Control-IQ 1.5, Tandem, mobi, t:slim X2, 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 v1.5Device
Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ technology v1.5.
Every month participants will receive a survey to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment. Participants will also complete surveys related to patient reported outcomes at baseline, 6 months, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Control-IQ Technology v1.5 | Real-world use of Control-IQ technology v1.5 for 12 months. Receives: Device: Control-IQ Technology v1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rates of Severe Hypoglycemia (SH)
Overall incidence rate of SH events per 100 patient years during 12 months of Control-IQ use
Measured: 12 months
Incidence Rates of Diabetic Ketoacidosis (DKA)
Overall incidence rate of DKA events per 100 patient years during 12 months of Control-IQ use
Measured: 12 months
Secondary outcomes (6)
Percent Time in Range 70 - 180 mg/dL
CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Greater Than 180 mg/dL
CGM measured percent time >180 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Greater Than 250 mg/dL
CGM measured percent time >250 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Less Than 70 mg/dL
CGM measured percent time <70 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Less Than 54 mg/dL
CGM measured percent time <54 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Mean Glucose mg/dL
CGM measured mean glucose during 12 months of Control-IQ use
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start30 Jan 2025
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Jordan Pinsker, MD, Principal investigator, Chief Medical Officer, Tandem Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717451
- Sponsor's protocol ID
- TP-0017060
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PS230005 Control-IQ 1.5 Post-Approval Study
- ClinicalTrials.gov ID
- NCT06717451
- Acronym / sponsor ID
- TP-0017060
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, Control-IQ, Control-IQ 1.5, Tandem, mobi, t:slim X2, automated insulin delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 5 Dec 2024 (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.
This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to <6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.
Detailed description
The study will recruit participants age 2 to <6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control-IQ Technology v1.5 | – | Device: Control-IQ Technology v1.5Real-world use of Control-IQ technology v1.5 for 12 months. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Enrollment in the study will be available to all individuals age 2 to <6 years of age at time of screening who start therapy with Control-IQ Technology v1.5.
Key inclusion criteria (10 listed)
- Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump
- Age 2 to <6 years at time of screening
- Using an insulin approved for use in the pump
- Using an iCGM sensor approved for use with the pump
- Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.
Key exclusion criteria (2 listed)
- Use of any glucose-lowering therapy other than insulin.
- A medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in 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 v1.5Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ technology v1.5. Every month participants will receive a survey to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment. Participants will also complete surveys related to patient reported outcomes at baseline, 6 months, and 12 months. | Device | Control-IQ Technology v1.5 |
Primary outcome
Incidence Rates of Severe Hypoglycemia (SH)
Time frame: 12 months
Overall incidence rate of SH events per 100 patient years during 12 months of Control-IQ use
Incidence Rates of Diabetic Ketoacidosis (DKA)
Time frame: 12 months
Overall incidence rate of DKA events per 100 patient years during 12 months of Control-IQ use
6 secondary outcomes
Percent Time in Range 70 - 180 mg/dL
Time frame: 12 months
Percent Time Greater Than 180 mg/dL
Time frame: 12 months
Percent Time Greater Than 250 mg/dL
Time frame: 12 months
Percent Time Less Than 70 mg/dL
Time frame: 12 months
Percent Time Less Than 54 mg/dL
Time frame: 12 months
Mean Glucose mg/dL
Time frame: 12 months
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 1 Sep 2026.
- 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 Pinsker, MD principal investigator
Chief Medical Officer, Tandem Diabetes Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, 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 10 inclusion and 2 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 1 Sep 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?
Incidence Rates of Severe Hypoglycemia (SH) (time frame: 12 months). 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 1 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.