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Artificial Pancreas in Pediatric Patients (PEDarPAN) (PEDarPAN)

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

artificial pancreas

sensor augmented pump

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Artificial pancreas, SAP therapy, children, adolescents, type 1 diabetes

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical diagnosis of type 1 diabetes · The diagnosis of type 1 diabetes is based on the investigator's judgment
· C peptide levels and antibody determinations are not required
Daily insulin therapy for ≥ 12 months
Insulin pump therapy for ≥ 3 months
Age 6-18 years
A1C<10
Avoidance of acetaminophen-containing medications (i.e. Tachipirina, tachidol, tachiflu) while wearing the continuous glucose monitor.
Willingness to wear a continuous glucose sensor
Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD).

Exclusion Criteria:

Diabetic ketoacidosis in the past month
Hypoglycemic seizure or loss of consciousness in the past 3 months
History of seizure disorder (except for hypoglycemic seizure)
A1C>10
History of any heart disease including coronary artery disease, heart failure, or arrhythmias
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 , Glargine or Degludec).
Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
Pregnancy - verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned.
Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/hotel admission if these criteria are not met. 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 Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAP

Arm Description

Experimental arm: A closed-loop control system (artificial pancreas) will be used during night and day for 72 hours (3 days) with the aim of automate insulin infusion by an insulin pump to control glucose level. AP is composed of a CGM device (Dexcom G4), an insulin pump (Accu Chek Spirit combo, Roche), and a model predictive control algorithm that is embedded in a smartphone and wirelessly linked to the CGM device and insulin pump. A remote monitoring will be ensured all the time the AP will be active and study team will be present in the camp. Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence

Active Comparator: Sensor Augmented Pump (SAP teraphy : CGM + insulin pump) will be used for 72 hours during day and night (3 days). Patients will be randomly assigned to receive either 3 days of SAP (Control) followed by 3 days of automated closed-loop insulin delivery (intervention), or the inverted sequence

Outcomes

Primary Outcome Measures

Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl)

percentage of time spent in hypoglicemia (< 70 mg/dl or 3.9 mmol/L) both during day and night. All analyses will include a comparison of the results in Artificial Pancreas and SAP period

Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L)

percentage of time spent in target range (70-180 mg/dl or 3.9-10.0 mmol/L) both during day and night. All analyses will include a comparison of the results in Artificial pancraes and SAP period

Secondary Outcome Measures

Percentage of Time Artificial Pancreas is Active

percentage of time that the system worked without any technical problem

Full Information

NCT ID

NCT02620878

First Posted

November 18, 2015

Last Updated

April 23, 2019

Sponsor

University of Padova

1. Study Identification

Unique Protocol Identification Number

NCT02620878

Brief Title

Artificial Pancreas in Pediatric Patients (PEDarPAN)

Acronym

PEDarPAN

Official Title

Use of Artificial Pancreas in Pediatric Patients. Feasibility , Safety and Efficacy Study of an Automatic Control of Blood Glucose 24/24 at a Diabetes Camp

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Padova

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine safety, feasibility and efficacy (with respect to sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night closed-loop control in children and adolescents with type 1 diabetes.

Detailed Description

The AP prototype is based on a Modular Model Predictive Control algorithm (MMPC) implemented on the Diabetes Assistant (DiAs) wearable platform. The study will be divided in two parts: the first part will serve as a 3 days pilot study and will be conducted in a hotel/residence near the hospital. The investigators will recruit 6/8 children (5-12 years) and/or 6/8 adolescents (12-18 years), with type 1 diabetes who have experience with insulin pump. DiAs will be used 72 continuous hours of day and night. If part 1 will be successfully, after about 2-3 months, the study will move to the second part (the main part), that will consist in cross-over randomized study that will be conducted in a camp setting. The participants will be randomly assigned to the treatment arm (Artificial Pancreas) or to the control arm (sensor-augmented insulin pump). Then the same patient will be assigned to the other arm. Each treatment will be applied 3 consecutive days. During the first period (days 1-3) patients will do the same activites and will have the same diet as in the second period (day s 5-7). The investigators will recruit 30/40 children (5-12 years) and/or 30/40 adolescents (12-18 years), affected by type 1 diabetes who have experience with insulin pump therapy. The study has the permission of the Ethics Committee reference and the permission for "clinical investigation with devices not CE marked" by the Health Ministry.

6. Conditions and Keywords

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

Type 1 Diabetes

Keywords

Artificial pancreas, SAP therapy, children, adolescents, type 1 diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

SAP

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

artificial pancreas

Intervention Description

Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.

Intervention Type

Other

Intervention Name(s)

sensor augmented pump

Intervention Description

During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas

Primary Outcome Measure Information:

Title

Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl)

Description

percentage of time spent in hypoglicemia (< 70 mg/dl or 3.9 mmol/L) both during day and night. All analyses will include a comparison of the results in Artificial Pancreas and SAP period

Time Frame

3 days

Title

Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L)

Description

percentage of time spent in target range (70-180 mg/dl or 3.9-10.0 mmol/L) both during day and night. All analyses will include a comparison of the results in Artificial pancraes and SAP period

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Percentage of Time Artificial Pancreas is Active

Description

percentage of time that the system worked without any technical problem

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of type 1 diabetes · The diagnosis of type 1 diabetes is based on the investigator's judgment · C peptide levels and antibody determinations are not required Daily insulin therapy for ≥ 12 months Insulin pump therapy for ≥ 3 months Age 6-18 years A1C<10 Avoidance of acetaminophen-containing medications (i.e. Tachipirina, tachidol, tachiflu) while wearing the continuous glucose monitor. Willingness to wear a continuous glucose sensor Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD). Exclusion Criteria: Diabetic ketoacidosis in the past month Hypoglycemic seizure or loss of consciousness in the past 3 months History of seizure disorder (except for hypoglycemic seizure) A1C>10 History of any heart disease including coronary artery disease, heart failure, or arrhythmias 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 , Glargine or Degludec). Subjects requiring other anti-diabetic medications other than insulin (oral or injectable). Pregnancy - verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned. Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy. Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/hotel admission if these criteria are not met. 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

Daniela Bruttomesso, MD

Organizational Affiliation

University of Padova, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Padova

City

Padova

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

27208335

Citation

Del Favero S, Boscari F, Messori M, Rabbone I, Bonfanti R, Sabbion A, Iafusco D, Schiaffini R, Visentin R, Calore R, Moncada YL, Galasso S, Galderisi A, Vallone V, Di Palma F, Losiouk E, Lanzola G, Tinti D, Rigamonti A, Marigliano M, Zanfardino A, Rapini N, Avogaro A, Chernavvsky D, Magni L, Cobelli C, Bruttomesso D. Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe. Diabetes Care. 2016 Jul;39(7):1180-5. doi: 10.2337/dc15-2815. Epub 2016 May 10.

Results Reference

derived

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Artificial Pancreas in Pediatric Patients (PEDarPAN)

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