Skip to main content
OpenTrials
Completed

NCT Number: NCT03804983

Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin

The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus 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

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

About this study

This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.

Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Criteria for documented hyperglycemia (at least 1 must be met):
  • Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
  • Diagnosis of type 1 diabetes is based on the investigator's judgement
  • Criteria for requiring insulin at diagnosis (both criteria must be met):
  • Daily insulin therapy for ≥ 6 months
  • Insulin pump therapy for ≥ 3 months
  • Age 12-18 years
  • 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). If using glulisine, subject must be willing to switch to lispro or aspart.
  • Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
  • Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
  • For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study.
  • Total daily insulin dose (TDD) at least 10 U/day.

Exclusion criteria

  • Diabetic ketoacidosis in the past 6 months
  • Hypoglycemic seizure or loss of consciousness in the past 6 months
  • History of seizure disorder
  • History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  • History of altitude sickness
  • Chronic pulmonary conditions that could impair oxygenation
  • Cystic fibrosis
  • Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgement of the investigator, would be a contraindication to participation in the study.
  • History of ongoing renal disease (other than microalbuminuria).
  • Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or Glargine).
  • Pregnancy
  • Presence of a febrile illness within 24 hours of the Ski Admission
  • Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as:
  • Inpatient psychiatric treatment in the past 6 months
  • Uncontrolled adrenal insufficiency
  • Alcohol abuse

Treatment and study plan

Hybrid closed loop (HCL)

Device

Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Control-IQ with MyTDI

Device

Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.

Primary outcomes

  1. Percent Time in Range at Home Pre/Post Intervention at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.

Secondary outcomes

  1. Average CGM at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    Average of available CGM values within time frame

  2. Average CGM at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

    average of CGM values within time frame

  3. Percentage of CGM Values Below 50mg/dL at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    the percentage of CGM values falling below 50mg/dL, calculated as the number of CGM values <50mg/dL within the time frame divided by the total number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  4. Percentage of CGM Values Below 50mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)

    the percentage of CGM values falling below 50mg/dL, computed as the number of CGM values <50mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  5. Percentage of CGM Values Below 54mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

    the percentage of CGM values falling below 54mg/dL. computed as the number of CGM values <54mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  6. Percentage of CGM Values Below 60mg/dL at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  7. Percentage of CGM Values Below 60mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)

    the percentage of CGM values falling below 60mg/dL. computed as the number of CGM values <60mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  8. Percentage of CGM Values Below 70mg/dL at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  9. Percentage of CGM Values Below 70mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)

    the percentage of CGM values falling below 70mg/dL, computed as the number of CGM values <70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  10. Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

    the percentage of CGM values falling between 70mg/dL and 180mg/dL, computed as the number of CGM values <=180mg/dL and >70mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  11. Percentage of CGM Values Above 180mg/dL at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  12. Percentage of CGM Values Above 180mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

    the percentage of CGM values falling above 180mg/dL, computed as the number of CGM values >180mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  13. Percentage of CGM Values Above 250mg/dL at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  14. Percentage of CGM Values Above 250mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

    the percentage of CGM values falling above 250mg/dL, computed as the number of CGM values >250mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  15. Percentage of CGM Values Above 300mg/dL at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  16. Percentage of CGM Values Above 300mg/dL at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

    the percentage of CGM values falling above 300mg/dL, computed as the number of CGM values >300mg/dL within the time frame divided by the number of available CGM values within the time frame. CGM gaps inferior to 3 hours will be linearly interpolated.

  17. Change in Total Daily Insulin at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    sum of the recorded insulin injection over the time frame in units

  18. Change in Total Daily Insulin at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (baseline)

    sum of the recorded insulin injection over the time frame in units

  19. Change in Total Meal Carbohydrates at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    sum of the meal sized recorded over the time frame

  20. Change in Total Meal Carbohydrates at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)

    sum of the meal sized recorded over the time frame

  21. Change in Number of Hypoglycemic Events at Camp

    Time frame: 2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline)

    Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)

  22. Number of Hypoglycemia Treatment at Camp

    Time frame: 2 days during camp admission (Camp)

    Sum of the number of CHO treatments recorded over the time frame

  23. Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp

    Time frame: 2 days during camp admission (Camp)

    Sum of the amount of carbohydrates used for treatments recorded over the time frame

  24. Change in Hypoglycemia Events at Home

    Time frame: 5 days post camp (home) compared to 5 days before camp (baseline)

    change in number of hypoglycemia between baseline and home

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 15, 2019
Registry last updated
Aug 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.