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Home › Trials › NCT05111301 NCT05111301: 2IQ
Control-IQ Technology in Individuals With Type 2 Diabetes
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Summary Quick facts Who can join Endpoints Results Adverse events Publications Related trials Sources
Completed
NA
Results posted
Last updated 6 March 2024
What this trial tests
NA trial testing Control-IQ technology 1.5 in Type 2 Diabetes Treated With Insulin in 30 participants. Completed in 18 August 2022.
Timeline
30 November 2021
Primary endpoint
18 August 2022
Quick facts
Lead sponsor Tandem Diabetes Care, Inc. Phase NA Status Completed Study type INTERVENTIONAL Allocation non randomized Design parallel Masking none Primary purpose treatment Enrollment 30 Start date 30 November 2021 Primary completion 10 August 2022 Estimated completion 18 August 2022 Sites 3 locations across United States
Drugs / interventions tested
Control-IQ technology 1.5
Conditions studied
Sponsor
Tandem Diabetes Care, Inc.
Who can join
18 and older, any sex, with Type 2 Diabetes Treated With Insulin. 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.
CGM Time Below 54 mg/dL
Primary
· 14 weeks
CGM-measured percentage below 54 mg/dl, compared to baseline
Baseline
Group Value 95% CI Overall 0.00 0.00 – 0.11 Basal Insulin Only (Group A) 0.00 0.00 – 0.11 Multiple Daily Injections (Group B) 0.00 0.00 – 0.00
Open-Loop
Group Value 95% CI Overall 0.00 0.00 – 0.08 Basal Insulin Only (Group A) 0.00 0.00 – 0.12 Multiple Daily Injections (Group B) 0.00 0.00 – 0.03
Control-IQ
Group Value 95% CI Overall 0.02 0.00 – 0.07 Basal Insulin Only (Group A) 0.02 0.01 – 0.08 Multiple Daily Injections (Group B) 0.02 0.00 – 0.05
CGM Time Above 180 mg/dL
Primary
· 14 weeks
CGM-measured percentage above 180 mg/dl, compared to baseline
Baseline
Group Value 95% CI Overall 44 ± 25 Basal Insulin Only (Group A) 39 ± 15 Multiple Daily Injections (Group B) 48 ± 31
Open-Loop
Group Value 95% CI Overall 37 ± 20 Basal Insulin Only (Group A) 34 ± 22 Multiple Daily Injections (Group B) 39 ± 19
Control-IQ
Group Value 95% CI Overall 29 ± 18 Basal Insulin Only (Group A) 26 ± 15 Multiple Daily Injections (Group B) 31 ± 20
CGM Time In Range 70-180 mg/dL
Secondary
· 14 weeks
CGM-measured percentage in range 70-180 mg/dl, compared to baseline
Baseline
Group Value 95% CI Overall 56 ± 25 Basal Insulin Only (Group A) 61 ± 15 Multiple Daily Injections (Group B) 52 ± 31
Open-Loop
Group Value 95% CI Overall 63 ± 20 Basal Insulin Only (Group A) 66 ± 22 Multiple Daily Injections (Group B) 61 ± 18
Control-IQ
Group Value 95% CI Overall 71 ± 18 Basal Insulin Only (Group A) 74 ± 15 Multiple Daily Injections (Group B) 68 ± 20
CGM Time Below 70 mg/dL
Secondary
· 14 weeks
CGM-measured percentage below 70 mg/dl, compared to baseline
Baseline
Group Value 95% CI Overall 0.05 0.00 – 0.47 Basal Insulin Only (Group A) 0.00 0.00 – 0.25 Multiple Daily Injections (Group B) 0.11 0.00 – 0.47
Open-Loop
Group Value 95% CI Overall 0.10 0.00 – 0.51 Basal Insulin Only (Group A) 0.19 0.00 – 0.35 Multiple Daily Injections (Group B) 0.03 0.00 – 0.60
Control-IQ
Group Value 95% CI Overall 0.12 0.04 – 0.34 Basal Insulin Only (Group A) 0.09 0.05 – 0.25 Multiple Daily Injections (Group B) 0.13 0.03 – 0.36
CGM Time Above 250 mg/dL
Secondary
· 14 weeks
CGM-measured percentage above 250 mg/dl, compared to baseline
Baseline
Group Value 95% CI Overall 8.5 1.7 – 21.1 Basal Insulin Only (Group A) 12.9 1.7 – 14.7 Multiple Daily Injections (Group B) 6.8 2.4 – 29.6
Open-Loop
Group Value 95% CI Overall 6.7 2.1 – 12.2 Basal Insulin Only (Group A) 8.1 0.9 – 16.9 Multiple Daily Injections (Group B) 6.3 3.8 – 10.0
Control-IQ
Group Value 95% CI Overall 2.9 1.1 – 12.8 Basal Insulin Only (Group A) 1.9 0.8 – 7.5 Multiple Daily Injections (Group B) 2.9 1.3 – 13.1
CGM Time In Range 70-140 mg/dL
Secondary
· 14 weeks
CGM-measured percentage in range 70-140 mg/dl, compared to baseline
Baseline
Group Value 95% CI Overall 30 ± 17 Basal Insulin Only (Group A) 32 ± 13 Multiple Daily Injections (Group B) 28 ± 20
Open-Loop
Group Value 95% CI Overall 34 ± 22 Basal Insulin Only (Group A) 38 ± 23 Multiple Daily Injections (Group B) 31 ± 21
Control-IQ
Group Value 95% CI Overall 42 ± 18 Basal Insulin Only (Group A) 45 ± 17 Multiple Daily Injections (Group B) 40 ± 19
CGM Mean Glucose mg/dL
Secondary
· 14 weeks
CGM measured mean glucose mg/dL, compared to baseline
Baseline
Group Value 95% CI Overall 184 ± 42 Basal Insulin Only (Group A) 174 ± 22 Multiple Daily Injections (Group B) 192 ± 52
Open-Loop
Group Value 95% CI Overall 172 ± 32 Basal Insulin Only (Group A) 170 ± 35 Multiple Daily Injections (Group B) 174 ± 30
Control-IQ
Group Value 95% CI Overall 163 ± 28 Basal Insulin Only (Group A) 159 ± 23 Multiple Daily Injections (Group B) 166 ± 32
Coefficient of Variation (CV)
Secondary
· 14 weeks
CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline
Baseline
Group Value 95% CI Overall 28 24 – 31 Basal Insulin Only (Group A) 29 27 – 31 Multiple Daily Injections (Group B) 25 23 – 32
Open-Loop
Group Value 95% CI Overall 29 23 – 34 Basal Insulin Only (Group A) 30 23 – 31 Multiple Daily Injections (Group B) 29 23 – 34
Control-IQ
Group Value 95% CI Overall 28 24 – 31 Basal Insulin Only (Group A) 27 24 – 30 Multiple Daily Injections (Group B) 30 24 – 31
Severe Hypoglycemia (Needing Assistance)
Secondary
· 14 weeks
The number of severe hypoglycemic events (needing assistance)
Group Value 95% CI Overall 0 Basal Insulin Only (Group A) 0 Multiple Daily Injections (Group B) 0
DKA
Secondary
· 14 weeks
The number of DKA events
Group Value 95% CI Overall 0 Basal Insulin Only (Group A) 0 Multiple Daily Injections (Group B) 0
Hyperosmolar Hyperglycemic Syndrome
Secondary
· 14 weeks
The number of Hyperosmolar Hyperglycemic Syndrome events
Group Value 95% CI Overall 0 Basal Insulin Only (Group A) 0 Multiple Daily Injections (Group B) 0
All Serious Adverse Events
Secondary
· 14 weeks
The number of Serious Adverse Events
Group Value 95% CI Overall 0 Basal Insulin Only (Group A) 0 Multiple Daily Injections (Group B) 0
Adverse events — posted to ClinicalTrials.gov
Time frame: 14 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Basal Insulin Only (Group A)
Serious: 0/13 (0%)
Deaths: 0/13
Multiple Daily Injections (Group B)
Serious: 0/17 (0%)
Deaths: 0/17
Other adverse events (8 terms — click to expand) Reaction System Basal Insulin Only (Group A) Multiple Daily Injections … COVID-19 Respiratory, thoracic and mediastinal disorders — — Hyperglycemia Endocrine disorders — — Cerumen impaction Ear and labyrinth disorders — — Sunburn Skin and subcutaneous tissue disorders — — Asthma Respiratory, thoracic and mediastinal disorders — — Hyperglycemia Endocrine disorders — — Hyperglycemia Endocrine disorders — — Chest Pain Cardiac disorders — —
Data from ClinicalTrials.gov NCT05111301 adverse events section .
Sponsor's own description
A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Beneficial Effects of Control-IQ Automated Insulin Delivery in Basal-Bolus and Basal-Only Insulin Users With Type 2 Diabetes.
Levy CJ, Raghinaru D, Kudva YC, Pandit K, et al ·
· 2024
· cited 28×
· PMID 38230336
· DOI 10.2337/cd23-0025
Effectiveness and safety of automated insulin delivery in type 2 diabetes: a meta-analysis.
Zeng B, Jia H, Yang S, Zheng J, et al ·
· 2025
· PMID 41254762
· DOI 10.1186/s13098-025-02014-x
Role of automated insulin delivery in managing insulin-treated outpatients with type 2 diabetes: A systematic review and meta-analysis.
Kamrul-Hasan ABM, Pappachan JM, Nagendra L, Akter N, et al ·
· 2025
· PMID 41113485
· DOI 10.4239/wjd.v16.i10.111230
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT05111301 (US National Library of Medicine, public domain)Publications : Europe PMC API search by NCT ID, retrieved 10 June 2026Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by Tandem Diabetes Care, Inc.Last refreshed : 6 March 2024
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/NCT05111301.
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