Type 2 Diabetes Treated With Insulin2IQNCT05111301
Control-IQ Technology in Individuals With Type 2 Diabetes
A study of Type 2 Diabetes Treated With Insulin, run by Tandem Diabetes Care, Inc. at 3 sites in United States.
Trial summary
A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Nov 2021to 18 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and residing in the US
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year
- Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ technology)
- Total daily insulin dose ≤200 units/day
- Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin
- For females, not currently known to be pregnant
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- 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 of child-bearing 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.
- HbA1c ≥ 7.5% and ≤ 12% at screening
- Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
- Be willing to exercise for 30 minutes or more at least once per week during the main phase of the study
- Has the ability to read and understand written English
- Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.
Who cannot join
- Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology
- Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
- History of 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 unwillingness to agree to abstain from illicit drugs throughout the study.
- History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe
- History of significant vision, hearing, or dexterity problems that will impair use of the closed loop system
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- Use of glucocorticoids, beta blockers, sulfonylureas, meglitinides or other medications specifically listed in the protocol or determined by investigator to interfere with the study
- Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or other adjuvant medication specifically listed in the protocol, or starting a new glucose lowering agent during the trial.
- Unstable dose of any medication used for weight loss, as listed in the protocol, or starting a new medication for weight loss during the trial.
- Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (>450 ms)
- History of hemodialysis
- History of adrenal insufficiency
- Uncontrolled hypo- or hyperthyroidism
- Significant diabetes related complications, based on investigator assessment
- Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texas Diabetes and Endocrinology
Austin, Texas, 78731
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Control-IQ Technology in Individuals With Type 2 Diabetes (2IQ)
A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.
Read the detailed description
The objective of this prospective, multicenter study is to assess safety and explore glycemic outcomes associated with use of Control-IQ technology in adults with type 2 diabetes who require insulin. After an initial run-in period, all participants will use the study system (pump and CGM) for 6 weeks. Participants will perform exercise challenges once each week during the study.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Control-IQ technology 1.5
- Keywords
- type 2 diabetes, Control-IQ technology, automated insulin dosing, automated insulin delivery
- 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 technology 1.5Device
All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
| Study group | Role | What they receive |
|---|---|---|
| Basal Insulin Only (Group A) | Experimental | * 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use Receives: Device: Control-IQ technology 1.5 |
| Multiple Daily Injections (Group B) | Experimental | * 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use Receives: Device: Control-IQ technology 1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM Time Below 54 mg/dL
CGM-measured percentage below 54 mg/dl, compared to baseline
Measured: 14 weeks
CGM Time Above 180 mg/dL
CGM-measured percentage above 180 mg/dl, compared to baseline
Measured: 14 weeks
Secondary outcomes (6)
CGM Time In Range 70-180 mg/dL
CGM-measured percentage in range 70-180 mg/dl, compared to baseline
Measured: 14 weeks
CGM Time Below 70 mg/dL
CGM-measured percentage below 70 mg/dl, compared to baseline
Measured: 14 weeks
CGM Time Above 250 mg/dL
CGM-measured percentage above 250 mg/dl, compared to baseline
Measured: 14 weeks
CGM Time In Range 70-140 mg/dL
CGM-measured percentage in range 70-140 mg/dl, compared to baseline
Measured: 14 weeks
CGM Mean Glucose mg/dL
CGM measured mean glucose mg/dL, compared to baseline
Measured: 14 weeks
Coefficient of Variation (CV)
CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start30 Nov 2021
- Primary completion10 Aug 2022
- Study completion18 Aug 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Treated With InsulinStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
- Investigators
- Carol Levy, MD, Study chair, Icahn School of Medicine at Mt. Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111301
- Sponsor's protocol ID
- TP-0009569
- Acronym
- 2IQ
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2021
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Levy CJ, Raghinaru D, Kudva YC, Pandit K, Blevins T, Casaubon L, Desjardins D, Levister CM, O'Malley G, Reid C, Lum J, Kollman C, Beck RW. Beneficial Effects of Control-IQ Automated Insulin Delivery in Basal-Bolus and Basal-Only Insulin Users With Type 2 Diabetes. Clin Diabetes. 2024 Winter;42(1):116-124. doi: 10.2337/cd23-0025. Epub 2023 Aug 28.
PubMed 38230336
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control-IQ Technology in Individuals With Type 2 Diabetes (2IQ)
- ClinicalTrials.gov ID
- NCT05111301
- Acronym / sponsor ID
- 2IQ / TP-0009569
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- type 2 diabetes, Control-IQ technology, automated insulin dosing, automated insulin delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.
Detailed description
The objective of this prospective, multicenter study is to assess safety and explore glycemic outcomes associated with use of Control-IQ technology in adults with type 2 diabetes who require insulin. After an initial run-in period, all participants will use the study system (pump and CGM) for 6 weeks. Participants will perform exercise challenges once each week during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| Basal Insulin Only (Group A) | Experimental | Device: Control-IQ technology 1.5* 2 to 4 week CGM run-in * 2 to 4 week pump run-in * 6 weeks Control-IQ technology use |
| Multiple Daily Injections (Group B) | Experimental | Device: Control-IQ technology 1.5* 2 to 4 week CGM run-in * 2 to 4 week pump run-in * 6 weeks Control-IQ technology use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old and residing in the US
- Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year
- Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ technology)
- Total daily insulin dose ≤200 units/day
- Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin
Key exclusion criteria (15 listed)
- Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology
- Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
- History of 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 unwillingness to agree to abstain from illicit drugs throughout the study.
- History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe
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 1.5All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor. Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level. | Device | Basal Insulin Only (Group A), Multiple Daily Injections (Group B) |
Primary outcome
CGM Time Below 54 mg/dL
Time frame: 14 weeks
CGM-measured percentage below 54 mg/dl, compared to baseline
CGM Time Above 180 mg/dL
Time frame: 14 weeks
CGM-measured percentage above 180 mg/dl, compared to baseline
6 secondary outcomes
CGM Time In Range 70-180 mg/dL
Time frame: 14 weeks
CGM Time Below 70 mg/dL
Time frame: 14 weeks
CGM Time Above 250 mg/dL
Time frame: 14 weeks
CGM Time In Range 70-140 mg/dL
Time frame: 14 weeks
CGM Mean Glucose mg/dL
Time frame: 14 weeks
Coefficient of Variation (CV)
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38230336Levy CJ, Raghinaru D, Kudva YC, Pandit K, Blevins T, Casaubon L, Desjardins D, Levister CM, O'Malley G, Reid C, Lum J, Kollman C, Beck RW. Beneficial Effects of Control-IQ Automated Insulin Delivery in Basal-Bolus and Basal-Only Insulin Users With Type 2 Diabetes. Clin Diabetes. 2024 Winter;42(1):116-124. doi: 10.2337/cd23-0025. Epub 2023 Aug 28.
- 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.
Carol Levy, MD study chair
Icahn School of Medicine at Mt. Sinai
3 sites 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 Treated With Insulin, run by Tandem Diabetes Care, Inc. at 3 sites 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 12 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 6 Mar 2024). 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?
CGM Time Below 54 mg/dL (time frame: 14 weeks). 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?
On the ClinicalTrials.gov record for NCT05111301, which also lists 1 linked publication.
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 6 Mar 2024.