14 and older, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time in Target RangePrimary· 26 weeks
The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.
Group
Value
95% CI
Closed Loop Control (CLC)
71
± 12
Sensor-Augmented Pump (SAP)
59
± 14
CGM Time Above 180Secondary· 26 weeks
CGM-measured % above 180 mg/dL
Group
Value
95% CI
Closed Loop Control (CLC)
27
± 12
Sensor-Augmented Pump (SAP)
38
± 15
CGM Mean GlucoseSecondary· 26 weeks
CGM-measured mean glucose
Group
Value
95% CI
Closed Loop Control (CLC)
156
± 19
Sensor-Augmented Pump (SAP)
170
± 25
HbA1c at 26 WeeksSecondary· 26 weeks
Hemoglobin A1c measured at 26 weeks
Group
Value
95% CI
Closed Loop Control (CLC)
7.06
± 0.79
Sensor-Augmented Pump (SAP)
7.39
± 0.92
CGM Time Below 70Secondary· 26 weeks
CGM-measured % below 70 mg/dL
Group
Value
95% CI
Closed Loop Control (CLC)
1.58
± 1.15
Sensor-Augmented Pump (SAP)
2.25
± 1.46
CGM Time Below 54Secondary· 26 weeks
CGM-measured % below 54 mg/dL
Group
Value
95% CI
Closed Loop Control (CLC)
0.29
± 0.29
Sensor-Augmented Pump (SAP)
0.35
± 0.32
CGM Time in Range 70-140 mg/dLSecondary· 26 weeks
CGM-measured % in range 70-140 mg/dL
Group
Value
95% CI
Closed Loop Control (CLC)
46
± 12
Sensor-Augmented Pump (SAP)
36
± 12
Coefficient of VariabilitySecondary· 26 weeks
CGM measured glucose variability measured with the coefficient of variation (CV)
Group
Value
95% CI
Closed Loop Control (CLC)
34
± 5
Sensor-Augmented Pump (SAP)
36
± 5
Standard Deviation of CGMSecondary· 26 weeks
CGM measured glucose variability measured with the standard deviation (SD)
Group
Value
95% CI
Closed Loop Control (CLC)
53
± 12
Sensor-Augmented Pump (SAP)
62
± 13
CGM Time Below 60Secondary· 26 weeks
CGM-measured % below 60 mg/dL
Group
Value
95% CI
Closed Loop Control (CLC)
0.58
± 0.52
Sensor-Augmented Pump (SAP)
0.75
± 0.61
LBGISecondary· 26 weeks
Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Group
Value
95% CI
Closed Loop Control (CLC)
0.51
± 0.29
Sensor-Augmented Pump (SAP)
0.65
± 0.35
CGM Hypoglycemia EventsSecondary· 26 weeks
CGM-measured events of at least 15 consecutive minutes \<70mg/dL per week
Group
Value
95% CI
Closed Loop Control (CLC)
3.3
± 2.1
Sensor-Augmented Pump (SAP)
4.3
± 2.7
Adverse events — posted to ClinicalTrials.gov
Time frame: From protocol entry through last study date which is approximately 26-28 weeks per participant..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Closed Loop Control (CLC)
Serious: 4/112 (4%)
Deaths: 0/112
Sensor-Augmented Pump (SAP)
Serious: 0/56 (0%)
Deaths: 0/56
Serious adverse events (4 terms)
Reaction
System
Closed Loop Control (CLC)
Sensor-Augmented Pump (SAP)
Diabetic Ketoacidosis
Endocrine disorders
—
—
Concussion
Nervous system disorders
—
—
Otitis
Ear and labyrinth disorders
—
—
Cardiac Bypass Surgery
Cardiac disorders
—
—
Other adverse events (1 terms — click to expand)
Reaction
System
Closed Loop Control (CLC)
Sensor-Augmented Pump (SAP)
Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis
The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Trials testing the same drug.
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· completed
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Other University of Virginia trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Virginia
Last refreshed: 28 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03563313.