DiaCon Overnight Closed-Loop Glucose Control Study (DiaCon2)

Hvidovre University Hospital

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Open-loop control; Device: Closed-loop control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01444443

2106-07-0034

Details and patient eligibility

About

The objective of this in-clinic study is to test our closed-loop glucose control system in patients with type 1 diabetes.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65 years
• Type 1 diabetes duration > 2 years
• HbA1c < 8%
• Insulin pump user > 1 year

Exclusion criteria

• Use of medication affecting glucose metabolism
• Pregnancy or nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Closed-loop glucose control

Experimental group

Description:

Blood glucose controlled by control algorithm.

Treatment:

Device: Closed-loop control

Open-loop glucose control

Active Comparator group

Description:

Blood glucose controlled by patient

Treatment:

Other: Open-loop control