Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Dexcom CGM G5; Device: Continuous Subcutaneous Insulin Infusion

• Registration Number: NCT03369067
• Lead Sponsor: University of Virginia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-11
• Study Start: 2017-12-18
• Primary Completion: 2018-04-15
• Study Completion: 2018-04-15
• Results First Submitted: 2022-07-18
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Results First Posted: 2024-09-30
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. 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

2. 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)

3. Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years

4. Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.

5. Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study

6. Not being pregnant at the start of the trial. All female subjects of childbearing potential will be screened for pregnancy.

7. 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

1. Diabetic ketoacidosis in the past 6 months

2. Hypoglycemic seizure or loss of consciousness in the past 6 months

3. History of seizure disorder (except for hypoglycemic seizure)

4. History of any heart disease including coronary artery disease, heart failure, or arrhythmias

5. History of altitude sickness

6. Chronic pulmonary conditions that could impair oxygenation

7. Cystic fibrosis

8. 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.

9. History of ongoing renal disease (other than microalbuminuria).

10. Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).

11. Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).

12. Pregnancy

13. 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.

14. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artificial Pancreas Therapy	Dexcom CGM G5	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.
Sensor Augmented Pump Therapy	Dexcom CGM G5	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.
Sensor Augmented Pump Therapy	Continuous Subcutaneous Insulin Infusion	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.

Primary Outcome Measures

Name	Time	Method
Percent Time Spent Between 70 and 180 mg/dL	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 Outcome Measures

Name	Time	Method
Percent Time Spent <50 mg/dL	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.
Percent Time Spent <54 mg/dL	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.
Percent Time Spent <60 mg/dL	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.
Percent Time Spent <70 mg/dL	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.
Percent Time Spent >180 mg/dL	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.
Percent Time Spent >250 mg/dL	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.
Percent Time Spent >300 mg/dL	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.
Mean Glucose	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.
Glucose Variability	Skiing [9:30am-noon and 1:30pm-4pm	Variability of glucose during the Skiing period
Insulin	Skiing [9:30am-noon and 1:30pm-4pm]	Amount (U/kg) of insulin administered during the Skiing period
Carbohydrate (CHO) Treatment	Overall [48hr study admission]	The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Overall period.
CHO Treatment	Skiing [9:30am-noon and 1:30pm-4pm]	The amount of carbohydrates in grams administered as treatment for hypoglycemia in the Skiing period.
Percent Time Spent Between 70 and 150 mg/dL	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.

Trial Locations

Locations (3)

Barbara Davis Center, University of Colorado; 🇺🇸 Aurora, Colorado, United States

University of Virginia Center for Diabetes Technology; 🇺🇸 Charlottesville, Virginia, United States

Stanford University; 🇺🇸 Stanford, California, United States