Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6
* Device: Dexcom CGM G5
* Device: Continuous Subcutaneous Insulin Infusion


Participation Criteria
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Eligibility Criteria
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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. 8. 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Pancreas Therapy<br>Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety. | Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6<br>* 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].<br>* Other names: Automated Insulin Delivery Device;Device: Dexcom CGM G5<br>* 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<br>* Other names: Continuous Glucose monitoring;|
| Placebo Comparator: Sensor Augmented Pump Therapy<br>Subjects will use a Dexcom CGM G5 and their Continuous Subcutaneous Insulin Infusion devices (insulin pumps) to modulate their insulin delivery and control their glycemia. In addition a Dexcom G5 Share/Follow system will be used to remote monitor the participants and ensure safety. | Device: Dexcom CGM G5<br>* 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<br>* Other names: Continuous Glucose monitoring;Device: Continuous Subcutaneous Insulin Infusion<br>* Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.<br>* Other names: Insulin pump;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent time spent in glycemic zone (70-180mg/dl) | Primary outcome will be the percent time spent in desirable glycemic zone (70-180mg/dl) during the entirety of the camp. | up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump