Tandem Control-IQ
Tandem Diabetes Care
What it is
Control-IQ hybrid closed-loop technology, with randomized evidence on t:slim X2 and Dexcom CGM. It adjusts basal insulin and can give automatic correction boluses, while meals still require user input. US version 1.5 includes ages 2+; older international versions and the separate Control-IQ+ successor have their own labeling.
Editorial review: .
Most recent recorded citation date: 2020-08-27. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Time in range: DCLP3 randomized 168 people: 112 received Control-IQ and 56 the comparator. Mean TIR during six months was 71% versus 59%, an adjusted 11-point difference. It is not a direct comparison with another current AID algorithm.[2]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Score limitations. Ratings are editorial, anchored mainly to original Control-IQ on t:slim X2. Adult, pediatric and mixed-diabetes observational cohorts are not head-to-head comparisons. Control-IQ+ and Mobi hardware require their own generation-specific assessment.
Default calculation: 76 × 20 + 78 × 20 + 66 × 10 + 74 × 5 + 72 × 5 + 68 × 5 + 74 × 5 + 64 × 10 + 48 × 20 = 6780; divide by total weight 100. Unrounded weighted result: 67.8.
DCLP3 randomized 168 people: 112 received Control-IQ and 56 the comparator. Mean TIR during six months was 71% versus 59%, an adjusted 11-point difference. It is not a direct comparison with another current AID algorithm.[2]
DCLP3 reported mean time below 70 mg/dL of 1.58% with Control-IQ and 2.25% with the comparator. No severe hypoglycemia occurred in either arm; one DKA event occurred with Control-IQ.[2]
Adjusts basal delivery every five minutes and can give automatic correction boluses up to once an hour. Sleep and Exercise activities are available; meals still require user input.[1]
DCLP3 reported mean HbA1c 7.06% at 26 weeks and mean sensor glucose 156 mg/dL during treatment. Its adjusted HbA1c difference versus the comparator was −0.33 percentage points.[2]
The pediatric DCLP5 trial reported mean glucose CV 38% during 16 weeks of Control-IQ. The former generic claim of CV 27–34% was unsupported. This retained editorial rating needs calibration across comparable cohorts.[3]
User-enabled Exercise activity uses a 140–160 mg/dL treatment range. The manual describes a duration timer in this software generation; it still requires planning and does not eliminate exercise lows.[1]
Adjustable basal, carbohydrate-ratio and correction-factor profiles, plus Sleep and Exercise activities. Sleep can be scheduled.[1]
Tandem supports US and Canadian customers and has UK, European and Australian distribution. Exact Control-IQ versus Control-IQ+ software, sensor compatibility, indications and reimbursement vary by country.[7]
This rating mainly represents the tubed t:slim X2, with on-pump controls. Its manual limits water exposure to 0.91 m for 30 minutes and advises against swimming with it. The smaller Mobi is separate hardware.[1]
AID default: 50% glucose outcomes and low-glucose protection, 40% daily experience, 10% access and cost. Freedom includes tubing, wearability, water-use limits and controller requirements. These are editorial priorities; studies and device generations differ. Check each scorecard for its evidence and limits.
The full picture
Which generation? This record covers Control-IQ evidence and features, chiefly on the t:slim X2 pump. FDA-cleared US Control-IQ version 1.5 includes people with T1D aged 2 or older; that age expansion is not exclusive to Control-IQ+. The older international software 7.7 guide reviewed here specifies age 6 or older, while US version 1.5 has different minimum weight and insulin requirements. Local labeling and installed software determine eligibility. Control-IQ+ is a separate successor with its own indications and features.1015
Automation and customization. Control-IQ predicts glucose 30 minutes ahead and adjusts basal insulin every five minutes. Its standard treatment range is 112.5–160 mg/dL (6.3–8.9 mmol/L); automatic correction boluses can occur up to once an hour. Users enter meal carbohydrates and maintain basal, carbohydrate-ratio and correction-factor settings. These features reduce dosing work but do not remove meal management.1
Sleep and exercise. Sleep activity uses 112.5–120 mg/dL (6.3–6.7 mmol/L) and can be scheduled or started manually; it does not deliver automatic correction boluses. Exercise uses 140–160 mg/dL (7.8–8.9 mmol/L) and is enabled by the user, with a duration timer in the reviewed software. A configurable profile or activity mode is not a guarantee against lows.1
Wear and water. t:slim X2 has tubing and its own screen. The reviewed guide specifies water exposure no deeper than 0.91 m for 30 minutes and advises against swimming or prolonged submersion. Mobi has a different form factor and phone interaction, so its wearability and water limits should be compared separately rather than assigned to all Control-IQ systems.1
Adult/adolescent randomized trial. DCLP3 randomized 168 participants aged 14–71, including 112 to Control-IQ and 56 to a sensor-augmented pump, for six months. Mean TIR rose from 61% to 71% with Control-IQ while the comparator remained at 59%; the adjusted difference was 11 percentage points. Mean HbA1c at 26 weeks was 7.06% versus 7.39%, with an adjusted difference of −0.33 points. Mean time below 70 mg/dL was 1.58% versus 2.25%. No severe hypoglycemia occurred; one DKA event occurred in the Control-IQ arm.2
Pediatric randomized trial. DCLP5 randomized 101 children aged 6–13: 78 to Control-IQ and 23 to the comparator. Over 16 weeks, mean TIR rose from 53% to 67% versus 51% to 55%, an adjusted 11-point difference. Neither arm had severe hypoglycemia or DKA. Mean glucose CV was 38% in the Control-IQ arm during treatment; this does not support the earlier claim that all Control-IQ cohorts have CV 27–34%.3
Real-world evidence needs population labels. The Medicare/Medicaid study included 4,243 and 1,332 users respectively, totaling 5,075 with T1D and 500 with T2D. The Medicare group’s median TIR changed from 64% to 74% and GMI from 7.3% to 7.0%. Those are mixed-diabetes cohort figures, not T1D-only outcomes; the study was retrospective and did not provide CV. They support usefulness in routine care without proving superiority to another AID brand.4
Access and safety updates. Tandem has North American support and international distribution including the UK, European markets and Australia, but software and sensor combinations vary. Historical FDA corrections also show why exact versions matter: the t:connect iOS 2.7 app could drain t:slim X2 batteries and interrupt insulin, with a corrective 2.8.2 release in August 2024. A separate Mobi notice concerns versions 7.6.0.1, 7.6.0.3 and 7.7.0.1, with an update to 7.9.0.2. These notices describe specific corrections, not a withdrawal of every Control-IQ system.6789
What's next for this
- →Control-IQ+ is a separate current successor with expanded US indications and features. Its availability and sensor pairings depend on pump software and country; do not apply its label to older Control-IQ software.
Sources
- [1]
- [2]Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes · Peer-reviewed study · 2019-10-16
- [3]A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes · Peer-reviewed study · 2020-08-27
- [4]
- [5]
- [6]
- [7]Tandem international distribution partners · Manufacturer
- [8]FDA: t:connect iOS app battery-depletion correction · Regulatory decision
- [9]FDA: Tandem Mobi software correction · Regulatory decision
- [10]