ClinicalTrials.gg
CompletedNCT03368937Updated May 25, 2022Results posted

A Pilot Test of t:Slim X2 With Control-IQ Technology

An interventional study of Tandem t:slim X2 with Control-IQ Technology in Type1 Diabetes Mellitus, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by University of Virginia · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 74 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 73 studies in Diabetes Mellitus, Type 1 by University of Virginia — 4 open to participants now, 4 under way, none of them phase 3. Diabetes Mellitus, Type 1 · University of Virginia.

Enrollment
56th of 64
5 · median 28
Started
2017
with 3 others
No phase
58 of 73
2 open now
Registered
43rd of 73
by date

Among the 73 studies in Diabetes Mellitus, Type 1 by University of Virginia, this one is the 56th largest by enrollment of the 64 interventional ones that give a count, is one of 4 that started in 2017, is one of 58 with no phase, and was the 43rd registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

4 of the 73 studies in Diabetes Mellitus, Type 1 by University of Virginia are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 74 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 73 studies in Diabetes Mellitus, Type 1 by University of Virginia, or all of them as a file.
02

Study summary

A 36-48 hour admission testing the t:slim X2 with Control-IQ Technology

Read the detailed description

The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting prior to initiating home use in a Training protocol.

03

Conditions studied

  • Type1 Diabetes Mellitus

Keywords

  • Artificial Pancreas (AP)
  • Closed Loop Control (CLC)
  • Continuous Glucose Monitor (CGM)
  • Insulin Pump
04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

To be eligible for the study, a subject must meet the following criteria:

  1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
  2. Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
  3. Age 18.0 to \<75.0 years
  4. \<10.5%
  5. For females, not currently known to be pregnant If female and sexually active, must agree to use a form of to prevent pregnancy while a subject in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  6. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
  7. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
  8. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). Willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).
  9. Total daily insulin dose (TDD) at least 10 U/day and ≤100 U/day
  10. Weight at least 25 kg and not greater than 140 kg

Exclusion criteria

Exclusion Criteria:

  1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
  2. More than one episode of severe hypoglycemia involving seizure or loss of consciousness in the 6 months prior to enrollment
  3. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
  4. Hemophilia or any other bleeding disorder
  5. A condition, which in the opinion of the investigator or designee, would put the subject or study at risk
  6. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  7. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc. or TypeZero Technologies, LLC, 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Tandem t:slim X2 with Control-IQ Technology

    Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.

    Device: Tandem t:slim X2 with Control-IQ Technology

Interventions

  • DeviceTandem t:slim X2 with Control-IQ Technology

    Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.

06

What researchers measure

Primary outcomes

  1. System Suitability

    Technology Acceptance Questionnaire Score Scores are on a Likert Scale of 1-Not at All to 5-Extremely for Ease of Use, Usability and Trust in System Scores.

    Time frame: 36-48 hours

07

Results

Posted Feb 27, 2019

Participant flow

Participant flow — Overall Study
MilestoneTandem t:Slim X2 With Control-IQ Technology
Started5
Completed5
Not completed0

Outcome measures

PrimarySystem Suitability

Technology Acceptance Questionnaire Score Scores are on a Likert Scale of 1-Not at All to 5-Extremely for Ease of Use, Usability and Trust in System Scores.

Time frame:
36-48 hours
Reported as:
Mean · score on a scale
System Suitability
score on a scaleTandem t:Slim X2 With Control-IQ Technology
Ease of Use5 (5 to 5)
Usefulness4.8 (4 to 5)
Trust in System5 (5 to 5)

Adverse events

Collected over 48 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tandem t:Slim X2 With Control-IQ Technology0/5 (0%)0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tandem t:Slim X2 With Control-IQ Technology
Mean52.8 ± 15.9
Sex: Female, Male
Sex: Female, Male(Participants)Tandem t:Slim X2 With Control-IQ Technology
Female3
Male2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Tandem t:Slim X2 With Control-IQ Technology
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White5
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Tandem t:Slim X2 With Control-IQ Technology
United States5
08

Study locations

1 site
  • University of Virginia Center for Diabetes Technology
    Charlottesville, Virginia 22903, United States
09

References and documents

Publications

  • Brown S, Raghinaru D, Emory E, Kovatchev B. First Look at Control-IQ: A New-Generation Automated Insulin Delivery System. Diabetes Care. 2018 Dec;41(12):2634-2636. doi: 10.2337/dc18-1249. Epub 2018 Oct 10. PubMed 30305346 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Dec 2017, 0 months.

Results were first posted in Feb 2019, 1 year 2 months after primary completion.

Of 845 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 0 months is below that.

Counting every sponsor, half of 950 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2017
First posted
Dec 11, 2017
StartActual
Dec 8, 2017
Primary completionActual
Dec 11, 2017
CompletionActual
Dec 11, 2017
Results first posted
Feb 27, 2019
Last update
May 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03368937
Responsible party
Sue Brown (Principal Investigator, University of Virginia) — Principal investigator
First posted
Dec 11, 2017
Start date
Dec 8, 2017
Primary completion
Dec 11, 2017
Completion
Dec 11, 2017
Results posted
Feb 27, 2019
Last update
May 25, 2022

Study contacts

Sue A Brown, MD
principal investigator · University of Virginia Center for Diabetes Technology

Oversight

Data monitoring committee
Yes
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 May 2022. You cannot join it, but the record below documents what was studied.

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