Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp

University of Virginia

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Tandem t:slim X2 with Control-IQ Technology + Dexcom G6; Device: Dexcom CGM G5; Device: Continuous Subcutaneous Insulin Infusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03369067

20335

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups, including a placebo group

Artificial Pancreas Therapy

Experimental group

Description:

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.

Treatment:

Device: Dexcom CGM G5

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

Sensor Augmented Pump Therapy

Placebo Comparator group

Description:

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.

Treatment:

Device: Continuous Subcutaneous Insulin Infusion

Device: Dexcom CGM G5