NCT02160184

Brief Summary

The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 22, 2024

Status Verified

June 1, 2014

Enrollment Period

3.9 years

First QC Date

June 9, 2014

Last Update Submit

August 20, 2024

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.

    During the closed-loop period for each patient: 12 hours

Study Arms (1)

experimental

EXPERIMENTAL

Night under closed loop system

Device: Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)

Interventions

Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)DEVICE
experimental

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 Diabetes
  • Diabetes duration \> 3 years
  • Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
  • A1c 6-9%
  • No ketoacidosis during the previous 12 months
  • Glomerular Filtration Rate (GFR) \> 60 ml/kg/min m2
  • Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice

You may not qualify if:

  • Gastroparesis
  • Hypoglycemia unawareness
  • Uncorrected visual impairment
  • Deafness
  • BMI\> 35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Tauli University Hospital

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mercedes Rigla, MD, PhD

    Parc Tauli University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 10, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 22, 2024

Record last verified: 2014-06

Locations

ES(1)