Artificial Pancreas in Pediatric Patients (PEDarPAN) (PEDarPAN)

April 23, 2019 updated by: Daniela Bruttomesso, University of Padova

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy
        • University of Padova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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

  2. Daily insulin therapy for ≥ 12 months
  3. Insulin pump therapy for ≥ 3 months
  4. Age 6-18 years
  5. A1C<10
  6. Avoidance of acetaminophen-containing medications (i.e. Tachipirina, tachidol, tachiflu) while wearing the continuous glucose monitor.
  7. Willingness to wear a continuous glucose sensor
  8. Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD).

Exclusion Criteria:

  1. Diabetic ketoacidosis in the past month
  2. Hypoglycemic seizure or loss of consciousness in the past 3 months
  3. History of seizure disorder (except for hypoglycemic seizure)
  4. A1C>10
  5. History of any heart disease including coronary artery disease, heart failure, or arrhythmias
  6. Cystic fibrosis
  7. 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.
  8. History of ongoing renal disease (other than microalbuminuria).
  9. Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir , Glargine or Degludec).
  10. Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
  11. Pregnancy - verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned.
  12. Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
  13. 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.

  14. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AP

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
Device: artificial pancreas
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: SAP

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
Other: sensor augmented pump
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl)
Time Frame: 3 days

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
3 days
Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L)
Time Frame: 3 days

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
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Time Artificial Pancreas is Active
Time Frame: 3 days
percentage of time that the system worked without any technical problem
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Principal Investigator: Daniela Bruttomesso, MD, University of Padova, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3486/AO/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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