N/A
N=32
Artificial Pancreas in Pediatric Patients (PEDarPAN)
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02620878 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl) — 2; 6.7 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- artificial pancreas (Device); sensor augmented pump (Other)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- University of Padova
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl) |
2; 6.7 | — |
| PRIMARY Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L) |
56.8; 63.1 | — |
| SECONDARY Percentage of Time Artificial Pancreas is Active |
97 | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT02620878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.