CompletedNCT05683392Updated Dec 20, 2024Results posted

Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

An interventional study of t:slim X2 insulin pump with Control-IQ technology 2.0 in Type 1 Diabetes, sponsored by Tandem Diabetes Care, Inc.. Completed at 4 sites in United States. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Tandem Diabetes Care, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 2 Years to 80 Years
Sex: All

Study summary

The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.

Read the detailed description

This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.

Conditions studied

Type 1 Diabetes

Browse trials for

Keywords

Control-IQ technology
type 1 diabetes

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Tandem Diabetes Care, Inc. is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 2 to ≤ 81 years
Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment
Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility
Total Daily Insulin Dose (TDD) at least 2 units/day
Weight ≥ 20 lbs
HbA1c ≤ 10.5%
For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.
For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight.
Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol.
Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices.
Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)
Willing and able to perform study meal challenges.

Exclusion criteria

Exclusion Criteria:

More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
Inpatient psychiatric treatment in the past 6 months
For Female: Currently pregnant or planning to become pregnant during the time period of study participation
1. A negative pregnancy test will be required for all females of child-bearing potential
2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential
Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
Hemophilia or any other bleeding disorder
Hemoglobinopathy
History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
History of allergic reaction to Humalog or Novolog
Use of any medications determined by investigator to interfere with study
Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
History of adrenal insufficiency
History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
History of gastroparesis
A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 72 participants (actual)

Study arms

Experimental
Control-IQ 2.0 Lower Range First, then Standard Range
After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks.
Device: t:slim X2 insulin pump with Control-IQ technology 2.0
Experimental
Control-IQ 2.0 Standard Range First, then Lower Range
After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks.
Device: t:slim X2 insulin pump with Control-IQ technology 2.0

Interventions

Devicet:slim X2 insulin pump with Control-IQ technology 2.0
t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.

What researchers measure

Primary outcomes

Number of Severe Hypoglycemic Events
Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period
Time frame: 2 weeks
Number of Diabetic Ketoacidosis (DKA) Events
Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period
Time frame: 2 weeks

Secondary outcomes

Percent of Time <54 mg/dL
CGM percent time \<54 mg/dL during each study period.
Time frame: 2 weeks
Percent of Time <70 mg/dL
CGM percent time \<70 mg/dL during each study period.
Time frame: 2 weeks
Percent Time 70-140 mg/dL
CGM percent time 70-140 mg/dL during each study period.
Time frame: 2 weeks
Percent Time 70-180 mg/dL
CGM percent time 70-180 mg/dL during each study period.
Time frame: 2 weeks
Percent Time > 180 mg/dL
CGM percent time \>180 mg/dL during each study period.
Time frame: 2 weeks
Percent Time > 250 mg/dL
CGM percent time \>250 mg/dL during each study period.
Time frame: 2 weeks
Mean Glucose
Mean CGM glucose mg/dL during each study period.
Time frame: 2 weeks
Glucose SD
Glucose SD mg/dL during each study period.
Time frame: 2 weeks
Glucose Coefficient of Variation
Glucose Coefficient of Variation (%) during each study period.
Time frame: 2 weeks

Results

Posted Dec 20, 2024

Participant flow

Participant flow — Overall Study
Milestone	Control-IQ 2.0 Lower Range First, Then Standard Range	Control-IQ 2.0 Standard Range First, Then Lower Range
Started	36	36
Completed	36	36
Not completed	0	0

Outcome measures

PrimaryNumber of Severe Hypoglycemic Events

Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period

Time frame:: 2 weeks
Reported as:: Number · events

Number of Severe Hypoglycemic Events
events	Lower Range	Standard Range
Number of Severe Hypoglycemic Events	0	0

PrimaryNumber of Diabetic Ketoacidosis (DKA) Events

Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period

Time frame:: 2 weeks
Reported as:: Number · events

Number of Diabetic Ketoacidosis (DKA) Events
events	Lower Range	Standard Range
Number of Diabetic Ketoacidosis (DKA) Events	0	0

SecondaryPercent of Time <54 mg/dL

CGM percent time \<54 mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · percentage of time

Percent of Time <54 mg/dL
percentage of time	Lower Range	Standard Range
Percent of Time <54 mg/dL	0.4 (0.1 to 0.8)	0.3 (0.1 to 0.7)

SecondaryPercent of Time <70 mg/dL

CGM percent time \<70 mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · percentage of time

Percent of Time <70 mg/dL
percentage of time	Lower Range	Standard Range
Percent of Time <70 mg/dL	2.0 (0.9 to 3.3)	1.6 (0.7 to 3.0)

SecondaryPercent Time 70-140 mg/dL

CGM percent time 70-140 mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · percentage of time

Percent Time 70-140 mg/dL
percentage of time	Lower Range	Standard Range
Percent Time 70-140 mg/dL	43.9 (38.2 to 51.3)	39.2 (30.9 to 48.1)

SecondaryPercent Time 70-180 mg/dL

CGM percent time 70-180 mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · percentage of time

Percent Time 70-180 mg/dL
percentage of time	Lower Range	Control-IQ 2.0 Lower Range
Percent Time 70-180 mg/dL	68.0 (60.5 to 74.3)	65.8 (54.4 to 73.0)

SecondaryPercent Time > 180 mg/dL

CGM percent time \>180 mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · percentage of time

Percent Time > 180 mg/dL
percentage of time	Lower Range	Standard Range
Percent Time > 180 mg/dL	30.5 (23.9 to 36.3)	33.0 (25.2 to 43.8)

SecondaryPercent Time > 250 mg/dL

CGM percent time \>250 mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · percentage of time

Percent Time > 250 mg/dL
percentage of time	Lower Range	Standard Range
Percent Time > 250 mg/dL	9.9 (5.1 to 15.3)	10.6 (5.7 to 18.5)

SecondaryMean Glucose

Mean CGM glucose mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · mg/dL

Mean Glucose
mg/dL	Lower Range	Standard Range
Mean Glucose	160.2 (149.7 to 172.6)	166.0 (152.6 to 183.4)

SecondaryGlucose SD

Glucose SD mg/dL during each study period.

Time frame:: 2 weeks
Reported as:: Median · mg/dL

Glucose SD
mg/dL	Lower Range	Standard Range
Glucose SD	63.5 (52.5 to 71.0)	61.3 (53.8 to 72.7)

SecondaryGlucose Coefficient of Variation

Glucose Coefficient of Variation (%) during each study period.

Time frame:: 2 weeks
Reported as:: Median · percentage of coefficient of variation

Glucose Coefficient of Variation
percentage of coefficient of variation	Lower Range	Standard Range
Glucose Coefficient of Variation	38.1 (34.9 to 42.5)	37.3 (34.0 to 41.4)

Adverse events

Collected over Two weeks for each intervention.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lower Range	0/72 (0%)	0/72 (0%)	6/72 (8.3%)
Standard Range	0/72 (0%)	0/72 (0%)	15/72 (20.8%)

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Lower Range	Standard Range
Hyperglycemia with ketosisEndocrine disorders	1/72	6/72
Upper Respiratory Tract InfectionInfections and infestations	0/72	3/72
Hyperglycemia without ketosisEndocrine disorders	2/72	1/72
Urinary Tract InfectionRenal and urinary disorders	0/72	1/72
Foot InjuryMusculoskeletal and connective tissue disorders	0/72	1/72
Yeast InfectionInfections and infestations	0/72	1/72
Skin InfectionInfections and infestations	0/72	1/72
PainSkin and subcutaneous tissue disorders	1/72	0/72
COVID-19Infections and infestations	1/72	0/72
Sprained AnkleMusculoskeletal and connective tissue disorders	0/72	1/72

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Control-IQ 2.0 Lower Range First, Then Standard Range	Control-IQ 2.0 Standard Range First, Then Lower Range	Total
Mean	17.7 ± 14.2	16.3 ± 12.1	17.0 ± 13.1

Sex: Female, Male
Sex: Female, Male(Participants)	Control-IQ 2.0 Lower Range First, Then Standard Range	Control-IQ 2.0 Standard Range First, Then Lower Range	Total
Female	17	18	35
Male	19	18	37

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Control-IQ 2.0 Lower Range First, Then Standard Range	Control-IQ 2.0 Standard Range First, Then Lower Range	Total
Hispanic or Latino	7	3	10
Not Hispanic or Latino	29	32	61
Unknown or Not Reported	0	1	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Control-IQ 2.0 Lower Range First, Then Standard Range	Control-IQ 2.0 Standard Range First, Then Lower Range	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	1	3
White	32	32	64
More than one race	2	3	5
Unknown or Not Reported	0	0	0

Study locations

4 sites

Barbara Davis Center (Pediatric Clinic)
Aurora, Colorado 80045, United States
Barbara Davis Center
Aurora, Colorado 80045, United States
Joslin Diabetes Center
Boston, Massachusetts 02215, United States
University of Virginia
Charlottesville, Virginia 22903, United States

References and documents

Publications

Brown SA, Laffel LM, Akturk HK, Forlenza GP, Shah VN, Wadwa RP, Cobry EC, Isganaitis E, Schoelwer M, Lu VS, Rueda R, Sherer N, Corbett JP, Sasson-Katchalski R, Pinsker JE. Randomized, Crossover Trial of Control-IQ Technology with a Lower Treatment Range and a Modified Meal Bolus Module in Adults, Adolescents, Children, and Preschoolers with Varying Levels of Baseline Glycemic Control. Diabetes Technol Ther. 2025 Mar;27(3):187-193. doi: 10.1089/dia.2024.0501. Epub 2024 Nov 26. PubMed 39601043 ↗

Study documents

Protocol and statistical analysis plan · Sep 20, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05683392
Lead sponsor: Tandem Diabetes Care, Inc.
Responsible party: Sponsor
First posted: Jan 13, 2023
Start date: Feb 1, 2023
Primary completion: Dec 13, 2023
Completion: Dec 13, 2023
Results posted: Dec 20, 2024
Last update: Dec 20, 2024

Study contacts

Jordan Pinsker, MD

study director · Tandem Diabetes Care, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus→

Other studies from this sponsor

Tandem Diabetes Care, Inc.

Start the discussion