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Type 1 DiabetesNCT05204134

Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

A study testing Automated Insulin Delivery Settings Initialization and Adaptation Algorithm in people with Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Automated Insulin Delivery Settings Initialization and Adaptation Algorithm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
24 Mar 2022to 29 Sep 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects ≥ age 18 years
  • Clinical diagnosis of type 1 diabetes for at least one year
  • Using a basal/bolus regimen by injection (MDI therapy)
  • Total daily dose ≥10 units/day
  • Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump.
  • A1c ≥ 7.5% and ≤ 11% at screening
Show all 9Show fewer
  • Not pregnant or planning a pregnancy during the time period of the study.
  • Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
  • Willingness to follow study procedures and a signed informed consent form

Who cannot join

  • Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
  • Two or more episodes of diabetic ketoacidosis in the past 6 months
  • Inpatient psychiatric treatment in the past 6 months
  • History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study
  • Significant chronic kidney disease or hemodialysis
  • Significant liver disease
Show all 13Show fewer
  • History of adrenal insufficiency
  • Hypothyroidism or hyperthyroidism that is not appropriately treated
  • Other chronic disease/condition determined by investigator to interfere with participation in the study
  • Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
  • Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump
  • Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
  • Investigator judgement that subject would not be able to complete the trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Davis Center

    Aurora, Colorado, 80045

Other trials in United States

About this study

Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.

Read the detailed description

This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.

Conditions
Type 1 Diabetes
Being tested
Automated Insulin Delivery Settings Initialization and Adaptation Algorithm
Keywords
type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery
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.

  • Automated Insulin Delivery Settings Initialization and Adaptation AlgorithmDevice

    All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.

Study groups in NCT05204134
Study groupRoleWhat they receive
Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular UpdatesExperimentalAfter CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.
Receives: Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severe Hypoglycemic Events

    Number of Severe Hypoglycemic Events (with altered mental status)

    Measured: 15 weeks

  2. Diabetic Ketoacidosis Events

    Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)

    Measured: 15 weeks

Secondary outcomes (25)

  1. Percent Time < 54 mg/dL, Overall

    CGM percent time < 54 mg/dL, Overall Study Participation

    Measured: 15 weeks

  2. Percent Time < 54 mg/dL, Daytime Outcomes

    CGM percent time < 54 mg/dL, Daytime Outcomes between 06:00-00:00

    Measured: 15 weeks

  3. Percent Time < 54 mg/dL, Overnight Outcomes

    CGM percent time < 54 mg/dL, Overnight Outcomes between 00:00-06:00

    Measured: 15 weeks

  4. Percent Time < 70 mg/dL, Overall

    CGM percent time < 70 mg/dL, Overall Study Participation

    Measured: 15 weeks

  5. Percent Time < 70 mg/dL, Daytime Outcomes

    CGM percent time < 70 mg/dL, Daytime Outcomes between 06:00-00:00

    Measured: 15 weeks

  6. Percent Time < 70 mg/dL, Overnight Outcomes

    CGM percent time < 70 mg/dL, Overnight Outcomes between 00:00-06:00

    Measured: 15 weeks

  7. Percent of Time 70-140 mg/dL, Overall

    CGM percent time 70-140 mg/dL, Overall Study Participation

    Measured: 15 weeks

  8. Percent of Time 70-140 mg/dL, Daytime Outcomes

    CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00

    Measured: 15 weeks

  9. Percent of Time 70-140 mg/dL, Overnight Outcomes

    CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00

    Measured: 15 weeks

  10. Percent of Time 70-180 mg/dL, Overall

    CGM percent time 70-180 mg/dL, Overall Study Participation

    Measured: 15 weeks

  11. Percent of Time 70-180 mg/dL, Daytime Outcomes

    CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00

    Measured: 15 weeks

  12. Percent of Time 70-180 mg/dL, Overnight Outcomes

    CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00

    Measured: 15 weeks

  13. Percent Time > 180 mg/dL, Overall

    CGM percent time > 180 mg/dL, Overall Study Participation

    Measured: 15 weeks

  14. Percent Time > 180 mg/dL, Daytime Outcomes

    CGM percent time > 180 mg/dL, Daytime Outcomes between 06:00-00:00

    Measured: 15 weeks

  15. Percent Time > 180 mg/dL, Overnight Outcomes

    CGM percent time > 180 mg/dL, Overnight Outcomes between 00:00-06:00

    Measured: 15 weeks

  16. Percent Time > 250 mg/dL, Overall

    CGM percent time > 250 mg/dL, Overall Study Participation

    Measured: 15 weeks

  17. Percent Time > 250 mg/dL, Daytime Outcomes

    CGM percent time > 250 mg/dL, Daytime Outcomes between 06:00-00:00

    Measured: 15 weeks

  18. Percent Time > 250 mg/dL, Overnight Outcomes

    CGM percent time > 250 mg/dL, Overnight Outcomes between 00:00-06:00

    Measured: 15 weeks

  19. Median Sensor Glucose

    CGM-measured median glucose (mg/dL)

    Measured: 15 weeks

  20. Total Daily Insulin Use

    Total Daily Insulin Use (Units/Day)

    Measured: 15 weeks

  21. Total Daily Bolus Insulin Use

    Total Daily Bolus Insulin Use (units/day)

    Measured: 15 weeks

  22. Total Daily Basal Insulin Use

    Total Daily Basal Insulin Use (units/day)

    Measured: 15 weeks

  23. Physician Overrides/Physician Initiated Changes in Pump Settings

    Number of physician overrides/physician initiated changes in pump settings during the entire study.

    Measured: 13 weeks

  24. Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion

    The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings

    Measured: 13 weeks

  25. Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion

    The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start24 Mar 2022
  3. Primary completion9 Sep 2022
  4. Study completion29 Sep 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204134
Sponsor's protocol ID
TP-0009348
Status last verified
Mar 2024
First submitted
10 Jan 2022
Last updated
5 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Shah VN, Akturk HK, Trahan A, Piquette N, Wheatcroft A, Schertz E, Carmello K, Mueller L, White K, Fu L, Sassan-Katchalski R, Messer LH, Habif S, Constantin A, Pinsker JE. Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology. J Diabetes Sci Technol. 2024 Nov;18(6):1281-1287. doi: 10.1177/19322968241229074. Epub 2024 Feb 7.

    PubMed 38323362

Questions about this trial

What is this clinical trial studying?

A study testing Automated Insulin Delivery Settings Initialization and Adaptation Algorithm in people with Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 1 site 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 9 inclusion and 13 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 5 Apr 2024). 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?

Severe Hypoglycemic Events (time frame: 15 weeks). The study lists 2 primary outcomes in all. 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 NCT05204134, 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 5 Apr 2024.

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