Artificial Pancreas in Pediatric Patients (PEDarPAN)

NCT02620878 | Completed Results

• 1 other identifier: 3486/AO/15
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  3 days

• 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

  3 days

Secondary Outcomes (1)

• Percentage of Time Artificial Pancreas is Active

  3 days

Study Arms (2)

AP

EXPERIMENTAL

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

SAP

ACTIVE COMPARATOR

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

Interventions

artificial pancreas 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.

AP

sensor augmented pump 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

SAP

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University of Padova

Padua, Italy

Location

Related Publications (1)

• 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.

  PMID: 27208335 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Daniela Bruttomesso
• Organization: Università di Padova-Italy

daniela.bruttomesso@unipd.it

00390498212183

Study Officials

• Daniela Bruttomesso, MD

  University of Padova, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 3, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 12, 2019
• Results First Posted: July 12, 2019

Record last verified: 2019-04

Locations

IT (1)