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Completed

NCT Number: NCT03369067

Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.

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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

6 year–18 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 proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and assess usability in a supervised setting in a controlled environment compared with state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes (T1D) in adolescents. Phase 1 participants (13-18 years old) and Phase 2 participants (6-12 years old) will be assessed during a ~48 hour ski camp; Upon completion of the ski camp, Phase 2 participants (6-12 years old) will also be assessed during a ~78 hour home use.

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)
  • The diagnosis of type 1 diabetes is based on the investigator's judgment
  • Criteria for requiring insulin at diagnosis (both criteria must be met):
  • Daily insulin therapy for ≥ 6 months
  • Insulin pump therapy for ≥ 3 months (note: must be willing to disable any glucose suspend, predictive suspend, or artificial pancreas functionality on insulin pump during study)
  • Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years
  • Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
  • Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
  • Not being pregnant at the start of the trial. All female subjects of childbearing potential will be screened for pregnancy.
  • If the participant is less than 13 years of age and the parents or the study team request it, at least one parent commit to stay with the study subject at the camp site 9. A parent/caregiver is available for system training and will commit to be the main responsible person for the use of the AP system at home

Exclusion criteria

  • Diabetic ketoacidosis in the past 6 months
  • Hypoglycemic seizure or loss of consciousness in the past 6 months
  • History of seizure disorder (except for hypoglycemic seizure)
  • 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 judgment 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).
  • Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
  • Pregnancy
  • Presence of a febrile illness within 24 hours of start ski camp or acetaminophen use while wearing the CGM. The camp study subject will not participate in the trial if these conditions are met.
  • Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as (for parent and/or child):
  • Inpatient psychiatric treatment in the past 6 months
  • Uncontrolled adrenal insufficiency
  • Alcohol abuse

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

Dexcom CGM G5

Device

The Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people ("followers") to receive in real-time information about the current blood glucose concentration and rate of change.

The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes

Other names: Continuous Glucose monitoring

Continuous Subcutaneous Insulin Infusion

Device

Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.

Other names: Insulin pump

Primary outcomes

  1. Percent Time Spent Between 70 and 180 mg/dL

    Time frame: Overall [48hr study admission]

    The primary outcome was the percent time spent between 70 and 180 mg/dL during the 48hr study admission.

  2. Percent Time Spent Between 70 and 180 mg/dL

    Time frame: Daytime [7am - 11pm]

    This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Daytime, defined as 7am-11pm.

  3. Percent Time Spent Between 70 and 180 mg/dL

    Time frame: Overnight [11pm - 7am]

    This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Overnight, defined as 11pm-7am.

  4. Percent Time Spent Between 70 and 180 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm.

Secondary outcomes

  1. Percent Time Spent <50 mg/dL

    Time frame: Overall [48hr study admission]

    The percentage of time spent below 50 mg/dL during the Overall period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.

  2. Percent Time Spent <54 mg/dL

    Time frame: Overall [48hr study admission]

    The percentage of time spent below 54 mg/dL during the Overall period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.

  3. Percent Time Spent <60 mg/dL

    Time frame: Overall [48hr study admission]

    The percentage of time spent below 60 mg/dL during the Overall period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.

  4. Percent Time Spent <70 mg/dL

    Time frame: Overall [48hr study admission]

    The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.

  5. Percent Time Spent >180 mg/dL

    Time frame: Overall [48hr study admission]

    The percentage of time spent above 180 mg/dL during the overall period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.

  6. Percent Time Spent >250 mg/dL

    Time frame: Overall [48hr study admission]

    The percentage of time spent above 250 mg/dL during the Overall period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.

  7. Percent Time Spent >300 mg/dL

    Time frame: Overall [48hr study admission]

    The percentage of time spent above 300 mg/dL. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.

  8. Mean Glucose

    Time frame: Overall [48hr study admission]

    Mean glucose is a measure of the average CGM value in mg/dL during the Overall period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.

  9. Glucose Variability

    Time frame: Overall [48hr study admission]

    Variability of glucose during the Overall period

  10. Insulin

    Time frame: Overall [48hr study admission]

    Amount (U/kg) of insulin administered during the Overall period

  11. Carbohydrate (CHO) Treatment

    Time frame: Overall [48hr study admission]

    The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period.

  12. Percent Time Spent <50 mg/dL

    Time frame: Daytime [7am - 11pm]

    The percentage of time spent below 50 mg/dL during the Daytime period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.

  13. Percent Time Spent <54 mg/dL

    Time frame: Daytime [7am - 11pm]

    The percentage of time spent below 54 mg/dL during the Daytime period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.

  14. Percent Time Spent <60 mg/dL

    Time frame: Daytime [7am - 11pm]

    The percentage of time spent below 60 mg/dL during the Daytime period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.

  15. Percent Time Spent <70 mg/dL

    Time frame: Daytime [7am - 11pm]

    The percentage of time spent below 70 mg/dL during the Daytime period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.

  16. Percent Time Spent >180 mg/dL

    Time frame: Daytime [7am - 11pm]

    The percentage of time spent above 180 mg/dL during the Daytime period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.

  17. Percent Time Spent >250 mg/dL

    Time frame: Daytime [7am - 11pm]

    The percentage of time spent above 250 mg/dL during the Daytime period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.

  18. Percent Time Spent >300 mg/dL

    Time frame: Daytime [7am - 11pm]

    The percentage of time spent above 300 mg/dL during the Daytime period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.

  19. Mean Glucose

    Time frame: Daytime [7am - 11pm]

    Mean glucose is a measure of the average CGM value in mg/dL during the Daytime period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.

  20. Glucose Variability

    Time frame: Daytime [7am - 11pm]

    Variability of glucose during the Daytime period

  21. Insulin

    Time frame: Daytime [7am - 11pm]

    Amount (U/kg) of insulin administered during the Daytime period

  22. CHO Treatment

    Time frame: Daytime [7am - 11pm]

    The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Daytime period.

  23. Percent Time Spent <50 mg/dL

    Time frame: Overnight [11pm - 7am]

    The percentage of time spent below 50 mg/dL during the Overnight period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.

  24. Percent Time Spent <54 mg/dL

    Time frame: Overnight [11pm - 7am]

    The percentage of time spent below 54 mg/dL during the Overnight period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.

  25. Percent Time Spent <60 mg/dL

    Time frame: Overnight [11pm - 7am]

    The percentage of time spent below 60 mg/dL during the Overnight period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.

  26. Percent Time Spent <70 mg/dL

    Time frame: Overnight [11pm - 7am]

    The percentage of time spent below 70 mg/dL during the Overall period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.

  27. Percent Time Spent Between 70 and 150 mg/dL

    Time frame: Overnight [11pm - 7am]

    This outcome looks at the percentage of time spent between 70 and 150 mg/dL during the Overnight, defined as 11pm-7am.

  28. Percent Time Spent >180 mg/dL

    Time frame: Overnight [11pm - 7am]

    The percentage of time spent above 180 mg/dL during the Overnight period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.

  29. Percent Time Spent >250 mg/dL

    Time frame: Overnight [11pm - 7am]

    The percentage of time spent above 250 mg/dL during the Overnight period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.

  30. Percent Time Spent >300 mg/dL

    Time frame: Overnight [11pm - 7am]

    The percentage of time spent above 300 mg/dL during the Overnight period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.

  31. Mean Glucose

    Time frame: Overnight [11pm - 7am]

    Mean glucose is a measure of the average CGM value in mg/dL during the Overnight period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.

  32. Glucose Variability

    Time frame: Overnight [11pm - 7am]

    Variability of glucose during the Overnight period

  33. Insulin

    Time frame: Overnight [11pm - 7am]

    Amount (U/kg) of insulin administered during the Overnight period

  34. CHO Treatment

    Time frame: Overnight [11pm - 7am]

    The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overnight period.

  35. Percent Time Spent <50 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The percentage of time spent below 50 mg/dL during the Skiing period. CGM measured blood sugar values below 50 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 50 mg/dL is considered a better outcome.

  36. Percent Time Spent <54 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The percentage of time spent below 54 mg/dL during the Skiing period. CGM measured blood sugar values below 54 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.

  37. Percent Time Spent <60 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The percentage of time spent below 60 mg/dL during the Skiing period. CGM measured blood sugar values below 60 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 60 mg/dL is considered a better outcome.

  38. Percent Time Spent <70 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The percentage of time spent below 70 mg/dL during the Skiing period. CGM measured blood sugar values below 70 mg/dL falls into the range of hypoglycemia which have the potential to lead to unconsciousness or death. Thus, less time below 70 mg/dL is considered a better outcome.

  39. Percent Time Spent >180 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The percentage of time spent above 180 mg/dL during the Skiing period. CGM measured blood sugar values above 180 mg/dL are considered to be undesirable. Thus, less time spent above 180 mg/dL is considered a positive outcome.

  40. Percent Time Spent >250 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The percentage of time spent above 250 mg/dL during the Skiing period. CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250 mg/dL is considered a positive outcome.

  41. Percent Time Spent >300 mg/dL

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The percentage of time spent above 300 mg/dL during the Skiing period. CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome.

  42. Mean Glucose

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    Mean glucose is a measure of the average CGM value in mg/dL during the Skiing period. A lower value, without approaching hypoglycemia, is indicative of a desirable outcome.

  43. Glucose Variability

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm

    Variability of glucose during the Skiing period

  44. Insulin

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    Amount (U/kg) of insulin administered during the Skiing period

  45. CHO Treatment

    Time frame: Skiing [9:30am-noon and 1:30pm-4pm]

    The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Skiing period.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Official study title

Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2017
Registry last updated
Oct 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.

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