Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format

NCT ID: NCT02160275

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Loop

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

Group Type: ACTIVE_COMPARATOR

Insulin pump therapy

Intervention Type: DEVICE

Patients' own insulin pump with fast-acting insulin analog

Closed Loop

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

Group Type: EXPERIMENTAL

Artificial Pancreas (Inreda Diabetic BV)

Intervention Type: DEVICE

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

Interventions

Artificial Pancreas (Inreda Diabetic BV)

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

Intervention Type: DEVICE

Insulin pump therapy

Patients' own insulin pump with fast-acting insulin analog

Intervention Type: DEVICE

Other Intervention Names

Continuous subcutaneous insulin infusion

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

J.H. DeVries

OTHER

Sponsor Role: lead

Responsible Party

J.H. DeVries

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

J. Hans DeVries, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Academic Medical Center

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

NL43469.018.13

Identifier Type: -

Identifier Source: org_study_id