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Completed

NCT Number: NCT04796779

The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes

The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) 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

24 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Stanford, California, United States

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About this study

Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a "closed-loop" system.

This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic.

A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months
  • Familiarity and use of a carbohydrate ratio for meal boluses.
  • Age ≥2 and <6 years old
  • Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
  • Investigator has confidence that the parent 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 using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study-provided Tandem pump during the study.
  • Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart
  • Total daily insulin dose (TDD) at least 5 U/day
  • Body weight at least 20 lbs.
  • Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3)
  • Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
  • Parent/guardian proficient in reading and writing English.

Exclusion criteria

  • Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 [GLP-1] agonists, Symlin, Dipeptidyl peptidase-4 [DPP-4] inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors, sulfonylureas).
  • Hemophilia or any other bleeding disorder
  • History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
  • History of >1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
  • History of chronic renal disease or currently on hemodialysis
  • History of adrenal insufficiency
  • Hypothyroidism that is not adequately treated
  • Use of oral or injectable steroids within the last 8 weeks
  • Known, ongoing adhesive intolerance
  • Plans to receive blood transfusions or erythropoietin injections during the course of the study
  • A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified in the study procedure manual)
  • Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM
  • Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  • 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

Treatment and study plan

Tandem t:slim X2 with Control-IQ Technology Pro

Device

The Tandem t:slim X2 with Control-IQ Technology Pro is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population.

Standard Care (SC)

Device

Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).

Tandem t:slim X2 with Control-IQ Technology V1.5

Device

The Tandem t:slim X2 with Control-IQ Technology V1.5 is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.

Primary outcomes

  1. Time in Range

    Time frame: 13 weeks

    Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM

Secondary outcomes

  1. CGM-measured Percent Above 250 mg/dL

    Time frame: 13 weeks

    Percentage of time with a glucose above 250 mg/dL as measured by CGM

  2. CGM-measured Mean Glucose

    Time frame: 13 weeks

    Average glucose value measured by CGM

  3. HbA1c at 13 Weeks

    Time frame: 13 weeks

    HbA1c at 13 weeks

  4. CGM-measured Percent Below 70 mg/dL

    Time frame: 13 weeks

    Percentage of time with glucose below 70 mg/dL as measured by CGM

  5. CGM-measured Percent Below 54 mg/dL

    Time frame: 13 weeks

    Percentage of time with glucose below 54 mg/dL as measured by CGM

Other outcomes

  1. Percent Above 180 mg/dL

    Time frame: 13 weeks

    percent above 180 mg/dL

  2. Percent in Range 70-140 mg/dL

    Time frame: 13 weeks

    percent in range 70-140 mg/dL

  3. Glucose Variability Measured With the Coefficient of Variation (CV)

    Time frame: 13 weeks

    glucose variability measured with the coefficient of variation (CV)

  4. Glucose Variability Measured With the Standard Deviation (SD)

    Time frame: 13 weeks

    glucose variability measured with the standard deviation (SD)

  5. CGM-measured Percent <60 mg/dL

    Time frame: 13 weeks

    CGM-measured percent <60 mg/dL

  6. Low Blood Glucose Index (LBGI)*

    Time frame: 13 weeks

    low blood glucose index (LBGI)*

  7. Hypoglycemic Events (Defined as at Least 15 Consecutive Minutes <54 mg/dL)

    Time frame: 13 weeks

    hypoglycemic events (defined as at least 15 consecutive minutes <54 mg/dL)

  8. Hyperglycemic Events (Defined as at Least 90 Consecutive Minutes >300 mg/dL)

    Time frame: 13 weeks

    hyperglycemic events (defined as at least 90 consecutive minutes >300 mg/dL)

  9. Percent >300 mg/dL

    Time frame: 13 weeks

    percent >300 mg/dL

  10. High Blood Glucose Index (HBGI)*

    Time frame: 13 weeks

    high blood glucose index (HBGI)*

  11. Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5 Percent

    Time frame: 13 weeks

    percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5 percent

  12. Percent in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10 Percent

    Time frame: 13 weeks

    percent in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10 percent

  13. Percent Time in Range 70-180 mg/dL >70 Percent and Percent Time <70 mg/dL <4 Percent

    Time frame: 13 weeks

    percent time in range 70-180 mg/dL >70 percent and percent time <70 mg/dL <4 percent

  14. HbA1c <7.0 Percent at 13 Weeks

    Time frame: 13 weeks

    HbA1c <7.0 percent at 13 weeks

  15. HbA1c <7.5 Percent at 13 Weeks

    Time frame: 13 weeks

    HbA1c <7.5 percent at 13 weeks

  16. HbA1c Improvement From Baseline to 13 Weeks >0.5 Percent

    Time frame: 13 weeks

    HbA1c improvement from baseline to 13 weeks >0.5 percent

  17. HbA1c Improvement From Baseline to 13 Weeks >1.0 Percent

    Time frame: 13 weeks

    HbA1c improvement from baseline to 13 weeks >1.0 percent

  18. HbA1c Relative Improvement From Baseline to 13 Weeks >10 Percent

    Time frame: 13 weeks

    HbA1c relative improvement from baseline to 13 weeks >10 percent

  19. HbA1c Absolute Improvement From Baseline to 13 Weeks >1.0 Percent or HbA1c <7.0 Percent at 13 Weeks

    Time frame: 13 weeks

    HbA1c absolute improvement from baseline to 13 weeks >1.0 percent or HbA1c <7.0 percent at 13 weeks

  20. Number of Severe Hypoglycemic (SH) Events and SH Event Rate Per 100 Person-years

    Time frame: 13 weeks

    Number of SH events and SH event rate per 100 person-years

  21. Number of Diabetic Ketoacidosis (DKA) Events and DKA Event Rate Per 100 Person-years

    Time frame: 13 weeks

    Number of DKA events and DKA event rate per 100 person-years

  22. Number of Other Serious Adverse Events

    Time frame: 13 weeks

    Number of other serious adverse events (SAEs other than SH events and DKA events)

  23. Any Adverse Event Rate

    Time frame: 13 weeks

    Any adverse event rate

  24. Number of Calendar Days With Any Ketone Level ≥1.0 mmol/L (if ≥5 Total Calendar Days Combined)

    Time frame: 13 weeks

    Number of calendar days with any ketone level ≥1.0 mmol/L (if ≥5 total calendar days combined)

  25. Worsening of HbA1c From Baseline to 13 Weeks by >0.5 Percent

    Time frame: 13 weeks

    Worsening of HbA1c from baseline to 13 weeks by >0.5 percent

  26. Adverse Device Effects (ADE)

    Time frame: 13 weeks

    Adverse device effects (ADE) in intervention group only

  27. Serious Adverse Device Events (SADE)

    Time frame: 13 weeks

    Serious adverse device events (SADE) in intervention group only

  28. Unanticipated Adverse Device Effects (UADE)

    Time frame: 13 weeks

    Unanticipated adverse device effects (UADE) in intervention group only

  29. Total Daily Insulin (Units/kg)

    Time frame: 13 weeks

    Total daily insulin (units/kg)

  30. Percentage of Total Insulin Delivered Via Basal

    Time frame: 13 weeks

    Percentage of total insulin delivered via basal

  31. Weight

    Time frame: 13 weeks

    Weight

  32. Body Mass Index (BMI)

    Time frame: 13 weeks

    Body Mass Index (BMI)

  33. PedsQL Diabetes Module - Total Score and 5 Subscales

    Time frame: 13 weeks

    PedsQL Diabetes Module - total score and 5 subscales: Diabetes, Treatment 1, Treatment 2, Worry, Communication

  34. Pediatric Inventory for Parents (PIP) 2 Domains Each With a Total Score and 4 Subscales for (5x2=10 Difference Scores)

    Time frame: 13 weeks

    Pediatric Inventory for Parents (PIP) 2 domains each with a total score and 4 subscales for (5x2=10 difference scores): Frequency (Total Score, Communication, Medical Care, Role Function, Emotional Functioning), Difficulty ( Same total + 4 subscales as above for frequency)

  35. INSPIRE Survey (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) (CLC Arm Only)

    Time frame: 13 weeks

    INSPIRE (CLC arm only) 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option.

  36. Pittsburgh Sleep Quality Index (PSQI) Global Score

    Time frame: 13 weeks

    An abbreviated 9-question version of the Pittsburgh Sleep Quality Index (PSQI), a validated tool for assessing self-reported sleep quantity and quality, will be completed by parents. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

  37. Fear of Hypoglycemia Survey for Parents (HFS-P) - Total Score, 2 Subscales and 4 Factor Scores

    Time frame: 13 weeks

    Fear of Hypoglycemia Survey for Parents (HFS-P) - total score, 2 subscales and 4 factor scores: Behavior (avoidance, Maintain high BG), Worry (Helplessness, Social consequences)

  38. Number of SH Events During, Immediately After and Overnight From the Study Challenges

    Time frame: Up to 24 hour period

    Number of SH events during, immediately after and overnight from the study challenges

  39. Number of Adverse Events During, Immediately After and Overnight From the Study Challenges

    Time frame: Up to 24 hour period

    Number of adverse events during, immediately after and overnight from the study challenges

  40. CGM-measured % <54 mg/dL Overnight (All Challenge Types)

    Time frame: 8 hours

    CGM-measured % <54 mg/dL overnight (all challenge types)

  41. CGM-measured % <70 mg/dL Overnight (All Challenge Types)

    Time frame: 8 hours

    CGM-measured % <70 mg/dL overnight (all challenge types)

  42. CGM-measured % >180 mg/dL Overnight (All Challenge Types)

    Time frame: 8 hours

    CGM-measured % >180 mg/dL overnight (all challenge types)

  43. CGM-measured % <54 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge

    Time frame: 2 hours

    CGM-measured % <54 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge

  44. CGM-measured % <70 mg/dL During the Two Hours Immediately Following the Start of Exercise for Each Exercise-related Challenge

    Time frame: 2 hours

    CGM-measured % <70 mg/dL during the two hours immediately following the start of exercise for each exercise-related challenge

  45. CGM-measured % >180 mg/dL During the Four Hours Following the Announced Meal, or Until the Next Meal Bolus is Given, for the Missed Meal Bolus Challenge

    Time frame: 4 hours

    CGM-measured % >180 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge

  46. CGM-measured % >300 mg/dL During the Four Hours Following the Announced Meal, or Until the Next Meal Bolus is Given, for the Missed Meal Bolus Challenge

    Time frame: 4 hours

    CGM-measured % >300 mg/dL during the four hours following the announced meal, or until the next meal bolus is given, for the missed meal bolus challenge

Sponsors and collaborators

Lead sponsor

Marc Breton

Other

Collaborators

  • Jaeb Center for Health Research
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Tandem Diabetes Care, Inc.

Registry information

Official study title

The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2021
Registry last updated
Jun 28, 2023

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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