Type 1 DiabetesNCT04084171
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
A study of Type 1 Diabetes, run by University of Virginia at 3 sites in United States.
Trial summary
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Sep 2019to 23 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 2 and < 6 years old at the time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment
- Use of an insulin pump in the past 3 months
- Use of Dexcom G6 for at least 11 out of the last 14 days
- Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses
- Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
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- At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team
- Investigator has confidence that the parent/guardian(s) can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) of at least 5 U/day
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
- Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff
- Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study
- Willingness to wear a Dexcom G6 sensor during the entire study
- An understanding and willingness to follow the protocol and sign informed consent
Who cannot join
- Hypoglycemia induced seizure or loss of consciousness in the past 3 months
- Diabetes Ketoacidosis in the past 3 months
- Use of diluted insulin
- Concurrent use of any non-insulin glucose-lowering agent
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include:
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- Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea)
- Addison's disease
- Diagnosed at less than 1 year of age without positive antibodies
- Decreased renal function
- Cystic fibrosis
- Other chronic conditions, such as an underlying seizure disorder
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
- Having a family member(s) 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Stanford University
Stanford, California, 94304
About this study
Official title: Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
Read the detailed description
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).
- Conditions
- Type 1 Diabetes
- Being tested
- Tandem t:slim X2 with Control-IQ Technology + Dexcom G6
- Keywords
- Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem t:slim X2 with Control-IQ Technology + Dexcom G6Device
Also called Artificial Pancreas, Automated Insulin Delivery Device
Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].
| Study group | Role | What they receive |
|---|---|---|
| Artificial Pancreas Therapy | Experimental | Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. Receives: Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Secondary outcomes (14)
Below 70 mg/dl.
Percent of time spent below 70 mg/dl.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 60 mg/dl.
Percent of time spent below 60mg/dl.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 54 mg/dl.
Percent of time spent below 54mg/dL.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 50mg/dl.
Percent of time spent below 50mg/dL.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 180 mg/dl.
Percent of time spent above 180mg/dl.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 250mg/dl.
Percent of time spent above 250mg/dl.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 300 mg/dl.
Percent of time spent above 300 mg/dl.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Between 70-140mg/dl.
Percent of time spent between 70 mg/dl and 140mg/dl.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Between 70-180mg/dl
Percent of time spent between 70 mg/dl and 180mg/dl.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Number of Hypoglycemia Below 70 mg/dL
Number of hypoglycemia events (below 70 mg/dL).
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Average Number of Treatments.
Average number of carbohydrate treatments per day. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request
Measured: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Average of Carbohydrate Treatments (g).
Average amount of carbohydrates (grams) used as a treatment. Participants were treated with ~16g fast-acting carbohydrates for CGM readings under 80mg/dL during the day and under 70mg/dL overnight (or at higher glycemic thresholds per parent discretion). A repeat treatment was considered if CGM value was<80mg/dL after ~20min. Hypoglycemic treatments could occur at any time per study physician request
Measured: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Percent of Time Spent in Closed Loop
Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.
Measured: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
CGM Consensus Goal
Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.
Measured: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start26 Sep 2019
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc., Tandem Diabetes Care, Inc.
- Responsible party
- Principal investigator, Marc Breton, University of Virginia
- Investigators
- Marc Breton, PhD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084171
- Sponsor's protocol ID
- 190031
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2019
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: To be determined
Publications
Ekhlaspour L, Schoelwer MJ, Forlenza GP, DeBoer MD, Norlander L, Hsu L, Kingman R, Boranian E, Berget C, Emory E, Buckingham BA, Breton MD, Wadwa RP. Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers. Diabetes Technol Ther. 2021 May;23(5):384-391. doi: 10.1089/dia.2020.0507. Epub 2020 Dec 8.
PubMed 33226837
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old
- ClinicalTrials.gov ID
- NCT04084171
- Acronym / sponsor ID
- 190031
- Conditions
- Type 1 Diabetes
- Keywords
- Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DexCom, Inc., Tandem Diabetes Care, Inc.
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 22 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
Detailed description
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artificial Pancreas Therapy | Experimental | Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Age ≥ 2 and < 6 years old at the time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment
- Use of an insulin pump in the past 3 months
- Use of Dexcom G6 for at least 11 out of the last 14 days
- Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses
Key exclusion criteria (14 listed)
- Hypoglycemia induced seizure or loss of consciousness in the past 3 months
- Diabetes Ketoacidosis in the past 3 months
- Use of diluted insulin
- Concurrent use of any non-insulin glucose-lowering agent
- Hemophilia or any other bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem t:slim X2 with Control-IQ Technology + Dexcom G6Also: Artificial Pancreas, Automated Insulin Delivery DeviceSubjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM]. | Device | Artificial Pancreas Therapy |
Primary outcome
Primary Outcome
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
14 secondary outcomes
Below 70 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 60 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 54 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Below 50mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 180 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 250mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Above 300 mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Between 70-140mg/dl.
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Between 70-180mg/dl
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Number of Hypoglycemia Below 70 mg/dL
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Average Number of Treatments.
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Average of Carbohydrate Treatments (g).
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
Percent of Time Spent in Closed Loop
Time frame: The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.
CGM Consensus Goal
Time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33226837Ekhlaspour L, Schoelwer MJ, Forlenza GP, DeBoer MD, Norlander L, Hsu L, Kingman R, Boranian E, Berget C, Emory E, Buckingham BA, Breton MD, Wadwa RP. Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers. Diabetes Technol Ther. 2021 May;23(5):384-391. doi: 10.1089/dia.2020.0507. Epub 2020 Dec 8.
- Individual participant dataSharing planned: Yes. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Breton, PhD principal investigator
University of Virginia Center for Diabetes Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 1 Diabetes, run by University of Virginia at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.