Clinical trial NCT02620878: Artificial Pancreas in Pediatric Patients (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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Artificial pancreas
SAP therapy
children
adolescents
type 1 diabetes
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl)
timeFrame: 3 days
measure: Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L)
timeFrame: 3 days
Secondary outcomes:
measure: Percentage of Time Artificial Pancreas is Active
timeFrame: 3 days
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
Study officials:
affiliation: University of Padova, Italy
name: Daniela Bruttomesso, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.