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OpenTrials
Completed

NCT Number: NCT05204134

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Davis Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

Device

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.

Primary outcomes

  1. Severe Hypoglycemic Events

    Time frame: 15 weeks

    Number of Severe Hypoglycemic Events (with altered mental status)

  2. Diabetic Ketoacidosis Events

    Time frame: 15 weeks

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

Secondary outcomes

  1. Percent Time < 54 mg/dL, Overall

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

  4. Percent Time < 70 mg/dL, Overall

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

  13. Percent Time > 180 mg/dL, Overall

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

  16. Percent Time > 250 mg/dL, Overall

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

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

    Time frame: 15 weeks

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

  19. Median Sensor Glucose

    Time frame: 15 weeks

    CGM-measured median glucose (mg/dL)

  20. Total Daily Insulin Use

    Time frame: 15 weeks

    Total Daily Insulin Use (Units/Day)

  21. Total Daily Bolus Insulin Use

    Time frame: 15 weeks

    Total Daily Bolus Insulin Use (units/day)

  22. Total Daily Basal Insulin Use

    Time frame: 15 weeks

    Total Daily Basal Insulin Use (units/day)

  23. Physician Overrides/Physician Initiated Changes in Pump Settings

    Time frame: 13 weeks

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

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

    Time frame: 13 weeks

    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

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

    Time frame: 13 weeks

    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

Sponsors and collaborators

Lead sponsor

Tandem Diabetes Care, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 24, 2022
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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