Back to results

Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Closed-Loop Control

Sensor Augmented Pump Therapy

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas (AP), Sensor-Augmented Pump (SAP) Therapy, Closed Loop Control, Insulin Pump, Continuous Glucose Monitor (CGM)

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be eligible for the study, a subject must meet the following:

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 ≥ 12 months
- Insulin pump therapy for ≥ 3 months
Age 10 - 25 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
Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD)

Exclusion Criteria: The presence of any of the following is an exclusion for the study:

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
Sexually active females who do not practice acceptable contraceptive methods to prevent 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:
- Inpatient psychiatric treatment in the past 6 months
- Uncontrolled adrenal insufficiency
- Alcohol abuse

Sites / Locations

University of Colorado, Denver, Barbara Davis Center
University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Closed-Loop Control (CLC) System

Sensor Augmented Pump Therapy Group

Arm Description

Subjects will use the Closed-Loop Control system in an attempt to maintain blood glucose in a certain range during the day and at night during the trial.

Subjects will manage their own glucose levels during the trial.

Outcomes

Primary Outcome Measures

Time in range when using closed-loop compared with SAP.

Secondary Outcome Measures

Reduction of hypoglycemia episodes when using closed-loop

assessed by the number of hypoglycemia treatments were needed for each group

Full Information

NCT ID

NCT02604524

First Posted

November 6, 2015

Last Updated

September 17, 2018

Sponsor

Daniel Chernavvsky, MD, CRC

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02604524

Brief Title

Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp

Official Title

Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Daniel Chernavvsky, MD, CRC

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The biggest challenges for glycemic control during the day time involve meals and exercise variations, which are impacted by age, fitness level, duration, intensity and history of exercise. Meal variability has the benefit that meals are typically announced and quantified. Glucose control around exercise, on the other hand, is more complicated if the patient doesn't announce a change in activity level.

Detailed Description

The object of this study is to evaluate the Closed-Loop Control (CLC) in an environment where muscle glycogen is systematically depleted, glucose uptake systematically increased, and meal sizes are naturally larger than normal: a week of camp at high altitude, with the concomitant variable of oxygen consumption that this environment involves; during the winter, that will expose and challenge the different components of the system during cold temperatures, and with twice daily practice of physical activity designed to deplete glycogen reserves such as skiing. This proposal aims to demonstrate the superiority of the CLC, also known as Artificial Pancreas (AP), compared to the state-of-the art system available on the market: Sensor-augmented pump (SAP). This system has shown to diminish hypoglycemic events by setting the alarms on the continues glucose monitor (CGM) and taken action, such as performing self-monitoring blood glucose (SMBG) and treating if it is confirm to be low.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus (T1DM), Artificial Pancreas (AP), Sensor-Augmented Pump (SAP) Therapy, Closed Loop Control, Insulin Pump, Continuous Glucose Monitor (CGM)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Closed-Loop Control (CLC) System

Arm Type

Experimental

Arm Description

Subjects will use the Closed-Loop Control system in an attempt to maintain blood glucose in a certain range during the day and at night during the trial.

Arm Title

Sensor Augmented Pump Therapy Group

Arm Type

Placebo Comparator

Arm Description

Subjects will manage their own glucose levels during the trial.

Intervention Type

Device

Intervention Name(s)

Closed-Loop Control

Other Intervention Name(s)

CLC

Intervention Description

Subjects will use the CLC during 5 nights/6 days at a ski camp.

Intervention Type

Other

Intervention Name(s)

Sensor Augmented Pump Therapy

Other Intervention Name(s)

SAP

Intervention Description

Subjects using their personal pumps with study CGM.

Primary Outcome Measure Information:

Title

Time in range when using closed-loop compared with SAP.

Time Frame

120-144 hours

Secondary Outcome Measure Information:

Title

Reduction of hypoglycemia episodes when using closed-loop

Description

assessed by the number of hypoglycemia treatments were needed for each group

Time Frame

120-144 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: To be eligible for the study, a subject must meet the following: 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 ≥ 12 months Insulin pump therapy for ≥ 3 months Age 10 - 25 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 Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD) Exclusion Criteria: The presence of any of the following is an exclusion for the study: 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 Sexually active females who do not practice acceptable contraceptive methods to prevent 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: Inpatient psychiatric treatment in the past 6 months Uncontrolled adrenal insufficiency Alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel R. Chernavvsky, MD, CRC

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado, Denver, Barbara Davis Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

undetermined

Citations:

PubMed Identifier

28855239

Citation

Breton MD, Chernavvsky DR, Forlenza GP, DeBoer MD, Robic J, Wadwa RP, Messer LH, Kovatchev BP, Maahs DM. Closed-Loop Control During Intense Prolonged Outdoor Exercise in Adolescents With Type 1 Diabetes: The Artificial Pancreas Ski Study. Diabetes Care. 2017 Dec;40(12):1644-1650. doi: 10.2337/dc17-0883. Epub 2017 Aug 30.

Results Reference

result

Learn more about this trial

Reducing Risks and Improving Glucose Control During Extended Exercise in Youth With T1DM: The AP Ski Camp

We'll reach out to this number within 24 hrs