Artificial Pancreas in Pediatric Patients (PEDarPAN)

NCT ID: NCT02620878

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-09-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

artificial pancreas

Intervention Type: DEVICE

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.

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

Group Type: ACTIVE_COMPARATOR

sensor augmented pump

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Daniela Bruttomesso

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Bruttomesso, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova, Italy

Locations

University of Padova

Padua, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 27208335 (View on PubMed)

Other Identifiers

3486/AO/15

Identifier Type: -

Identifier Source: org_study_id