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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-10

Study Completion Date

2019-09-12

Brief Summary

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In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open loop

14 days patient-managed Insulin pump therapy (with or without glucose sensor) with blinded continuous glucose monitoring

Group Type ACTIVE_COMPARATOR

Insulin pump therapy (with or without glucose sensor)

Intervention Type DEVICE

Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor

Closed loop

4-6 training + 14 days automated blood glucose control with the Artificial pancreas (Inreda Diabetic)

Group Type EXPERIMENTAL

Artificial pancreas (Inreda Diabetic)

Intervention Type DEVICE

Bi-hormonal reactive closed loop system without mealtime announcement

Interventions

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Insulin pump therapy (with or without glucose sensor)

Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor

Intervention Type DEVICE

Artificial pancreas (Inreda Diabetic)

Bi-hormonal reactive closed loop system without mealtime announcement

Intervention Type DEVICE

Other Intervention Names

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Continuous subcutaneous insulin infusion (CSII) Sensor augmented pump therapy (SAP) Closed loop therapy

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with diabetes mellitus type 1;
* Treated with SAP or CSII for a minimum of 6 months;
* 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;
* Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
* Limited ability to see, and to hear or feel alarm signals of the closed loop system;
* Skin condition prohibiting needle insertion;
* Pregnancy and/or breastfeeding;
* Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
* Expected poor connectivity with internet regarding 24/7 tele monitoring;
* 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