Last reviewed 2024-07-26 · How we verify

NCT05403502

Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

Completed NA Results posted Last updated 26 July 2024

What this trial tests

NA trial testing t:slim X2 insulin pump with Control-IQ technology 1.5 in Type 1 Diabetes in 183 participants. Completed in 2 August 2023.

Timeline

31 August 2022

Primary endpoint
2 August 2023

2 August 2023

Quick facts

Lead sponsor	Tandem Diabetes Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	183
Start date	31 August 2022
Primary completion	2 August 2023
Estimated completion	2 August 2023
Sites	13 locations across United States

Drugs / interventions tested

t:slim X2 insulin pump with Control-IQ technology 1.5

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Tandem Diabetes Care, Inc.

Who can join

Adults 6 to 80, any sex, with Type 1 Diabetes. 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.

Severe Hypoglycemia Primary · 15 weeks

Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	3

Diabetic Ketoacidosis Primary · 15 weeks

Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0

Unanticipated Adverse Device Effects Primary · 15 weeks

Number of unanticipated adverse device effects (UADE) events

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0

Overall Percent Time Less Than 54 mg/dL Secondary · 15 Weeks

CGM overall percent time less than 54 mg/dL

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0.27	± 0.35

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0.26	± 0.27

Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal Secondary · during 4 hour postprandial period after each meal, up to 15 weeks

CGM postprandial percent time less than 54 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0.26	± 0.44

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	0.31	± 0.37

Overall Percent Time Less Than 70 mg/dL Secondary · 15 weeks

CGM overall percent time less than 70 mg/dL

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	1.4	± 1.3

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	1.2	± 1.0

Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal Secondary · during 4 hour postprandial period after each meal, up to 15 weeks

CGM postprandial percent time less than 70 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	1.5	± 1.5

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	1.6	± 1.4

Overall Percent Time in Range Between 70-180 mg/dL Secondary · 15 weeks

Overall CGM percent time in range between 70-180 mg/dL

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	65	± 15

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	67	± 13

Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM) Secondary · 15 weeks

CGM percent time in range between 70-180 mg/dL, daytime only (6:00 AM - 11:59 PM)

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	62	± 15

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	64	± 14

Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM) Secondary · 15 weeks

CGM percent time in range between 70-180 mg/dL, nighttime only (12:00 AM - 5:59 AM)

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	72	± 18

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	75	± 15

Overall Percent Time in Range Between 70-140 mg/dL Secondary · 15 weeks

Overall CGM percent time in range between 70-140 mg/dL

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	40	± 14

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	42	± 13

Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM) Secondary · 15 weeks

CGM percent time in range between 70-140 mg/dL, daytime only (6:00 AM - 11:59 PM)

Humalog Lead-In Period Weeks 1-2 (2 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	38	± 14

Lyumjev Treatment Period Weeks 3-15 (13 Weeks)

Group	Value	95% CI
Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin	40	± 13

Adverse events — posted to ClinicalTrials.gov

Time frame: 15 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

t:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®

Serious: 5/183 (3%)

Deaths: 0/183

Serious adverse events (4 terms)

Reaction	System	t:Slim X2 Insulin Pump Wit…
Severe Hypoglycemia	Endocrine disorders	—
Other Serious Adverse Event	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Other Serious Adverse Event	Infections and infestations	—
Diabetic Ketoacidosis (DKA)	Endocrine disorders	—

Other adverse events (8 terms — click to expand)

Reaction	System	t:Slim X2 Insulin Pump Wit…
Nonglycemic adverse events	General disorders	—
Hyperglycemia with or without ketosis related to study device	Endocrine disorders	—
Nonglycemic adverse events	General disorders	—
Hyperglycemia with or without ketosis related to study device	Endocrine disorders	—
Hyperglycemia with or without ketosis not related to the study device	Endocrine disorders	—
Hyperglycemia with or without ketosis not related to the study device	Endocrine disorders	—
Nonsevere Hypoglycemia	Endocrine disorders	—
Nonsevere Hypoglycemia	Endocrine disorders	—

Most-reported serious reactions: Severe Hypoglycemia, Other Serious Adverse Event, Other Serious Adverse Event, Diabetic Ketoacidosis (DKA).

Data from ClinicalTrials.gov NCT05403502 adverse events section.

Sponsor's own description

Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes.
Levy CJ, Bailey R, Laffel LM, Forlenza G, et al · · 2024 · cited 14× · PMID 38696672 · DOI 10.1089/dia.2024.0048

Verify or expand the search:

Other trials of t:slim X2 insulin pump with Control-IQ technology 1.5

Trials testing the same drug.

NCT05422053 — Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ) · NA · completed

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting

Other Tandem Diabetes Care, Inc. trials

Trials by the same sponsor.

NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
NCT06834568 — Tandem Freedom - Feasibility Trial 2 · NA · completed
NCT06717451 — PS230005 Control-IQ 1.5 Post-Approval Study · active not recruiting
NCT05973422 — Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes · NA · unknown
NCT06428591 — Tandem Freedom Feasibility Study 1 · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05403502 (US National Library of Medicine, public domain)
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 Tandem Diabetes Care, Inc.
Last refreshed: 26 July 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/NCT05403502.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

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