Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, (APPEL5)

J.H. DeVries

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Artificial pancreas (Inreda Diabetic); Device: Insulin pump therapy (with or without glucose sensor)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03858062

NL55693.018.15

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Open loop

Active Comparator group

Description:

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

Treatment:

Device: Insulin pump therapy (with or without glucose sensor)

Closed loop

Experimental group

Description:

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

Treatment:

Device: Artificial pancreas (Inreda Diabetic)