NCT02160275

Brief Summary

In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. Glucose control with automated closed loop control was comparable to patient-managed open loop control. The closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. The aim of this trial is to assess the efficacy of the new prototype at the home of the patient. It is hypothesized that the closed loop system provides better glucose control than standard open loop therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

June 5, 2014

Last Update Submit

October 1, 2015

Conditions

Diabetes Mellitus, Type 1

Keywords

Artificial pancreasBi-hormonal closed loopDiabetes Type 1

Outcome Measures

Primary Outcomes (1)

  • Mean sensor glucose concentration

    Day 2-4

Secondary Outcomes (11)

  • Proportion of time spent in each glycemic category

    Day 2-4

  • Number of events in each glycemic category

    Day 2-4

  • Number of carbohydrate-treated hypoglycemic events

    Day 2-4

  • Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l)

    Day 2-4

  • Glycemic variability

    Day 2-4

  • +6 more secondary outcomes

Other Outcomes (5)

  • Demographic characteristics

    Baseline

  • Weight

    Baseline

  • Length

    Baseline

  • +2 more other outcomes

Study Arms (2)

Open Loop

ACTIVE COMPARATOR

4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring

Device: Insulin pump therapy

Closed Loop

EXPERIMENTAL

4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)

Device: Artificial Pancreas (Inreda Diabetic BV)

Interventions

Artificial Pancreas (Inreda Diabetic BV)DEVICE

Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype

Closed Loop
Insulin pump therapyDEVICE

Patients' own insulin pump with fast-acting insulin analog

Also known as: Continuous subcutaneous insulin infusion
Open Loop

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with diabetes mellitus type 1
  • Treated with insulin pump therapy for a minimum of 6 months
  • Age between 18 and 75 years
  • Willing and able to sign informed consent

You may not qualify if:

  • Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire
  • BMI \> 35 kg/m2
  • HbA1c \> 97 mmol/mol (=11.0 %)
  • Use of heparin, coumarin derivatives or oral corticosteroids
  • Skin condition prohibiting needle insertion
  • Pregnancy and/or breastfeeding
  • Living alone during the closed loop period (the patient may ask someone to stay over temporarily)
  • Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artificial OrgansSurgical EquipmentEquipment and Supplies

Study Officials

  • J. Hans DeVries, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 10, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 2, 2015

Record last verified: 2015-10

Locations

NL(2)