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Completed

NCT Number: NCT04084171

Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

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

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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

2 year–6 year

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

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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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:
  • 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.

Treatment and study plan

Tandem t:slim X2 with Control-IQ Technology + Dexcom G6

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].

Other names: Artificial Pancreas, Automated Insulin Delivery Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Percent of time spent below 70 mg/dl.

  2. 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.

    Percent of time spent below 60mg/dl.

  3. 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.

    Percent of time spent below 54mg/dL.

  4. 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.

    Percent of time spent below 50mg/dL.

  5. 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.

    Percent of time spent above 180mg/dl.

  6. 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.

    Percent of time spent above 250mg/dl.

  7. 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.

    Percent of time spent above 300 mg/dl.

  8. 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.

    Percent of time spent between 70 mg/dl and 140mg/dl.

  9. 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.

    Percent of time spent between 70 mg/dl and 180mg/dl.

  10. 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.

    Number of hypoglycemia events (below 70 mg/dL).

  11. 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 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

  12. 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.

    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

  13. 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.

    Percentage of the amount of time spent with the Control-IQ system running in closed loop mode.

  14. 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.

    Percentage of subjects with more than 70% time in 70-180mg/dL range with less than 4% time below 70mg/dL.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • DexCom, Inc.
  • Tandem Diabetes Care, Inc.

Registry information

Official study title

Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2019
Registry last updated
Mar 22, 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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