The main objective of this study is to determine the performance of the closed-loop system in adolescents with T1DM. Secondary objectives include: • to assess the safety of the closed-loop system; • to determine the time that the closed-loop…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the percentage of time spent in the target range
(3.9-10.0 mmol/L), which will be compared between the open and closed-loop
periods for each patient.
Secondary outcome
The safety parameters are:
• The proportion of time spent in the following categories:
o Hypoglycaemia (< 3.9 mmol/L);
o Hypoglycaemia (< 3.0 mmol/L);
o Hyperglycaemia (> 10.0 mmol/L);
o Hyperglycaemia (> 13.9 mmol/L).
Secondary performance parameters are:
• Mean or median sensor glucose concentration;
• Glycaemic variability;
• Day and night mean or median sensor glucose concentration;
• Day and night time spent in hypo-, hyper- and euglycaemia.
• Percentage of time that the closed-loop algorithm is active (closed-loop
period only).
• Expectations of the closed-loop system and treatment satisfaction scores in
patients and their parents (expectations for closed-loop only).
Background summary
In previous studies, we tested the performance and safety of a bihormonal
reactive closed-loop system without mealtime announcement. This system for
automated control of blood glucose in patients with type 1 diabetes mellitus
(T1DM) was tested in an outpatient setting for 3 days (APPEL 4) and 2 weeks
(APPEL 5). The results of the APPEL 4 study suggest improved time in target
glucose (3.9-10.0 mmol/L) with closed-loop control. The results of the APPEL 5
study demonstrated vastly improved glycaemic control and this has consequently
facilitated CE-marking of the system. The device is currently intended for
insulin-dependent adult patients with diabetes. However, there is great need to
improve glycaemic control in youth and adolescents with diabetes.
Study objective
The main objective of this study is to determine the performance of the
closed-loop system in adolescents with T1DM.
Secondary objectives include:
• to assess the safety of the closed-loop system;
• to determine the time that the closed-loop algorithm is active;
• and to assess expectations and treatment satisfaction of the closed-loop
system.
Study design
This study is a monocenter randomized cross-over trial.
Intervention
The intervention includes 2 weeks of closed-loop control with the artificial
pancreas (AP) of Inreda Diabetic. The device uses 2 subcutaneous glucose
sensors, 2 subcutaneous infusion sets, and incorporates 2 pumps and a patented
reactive closed-loop algorithm. During 4-6 days before the intervention the
patients receive training on the use of the closed-loop system and will start
using the device under close supervision. The control arm (open loop treatment)
consists of the patient*s standard therapy at home for 2 weeks.
Study burden and risks
The patients will have to wear the device with the subcutaneous glucose sensors
and infusion sets. In addition, participants will wear a blinded sensor during
the closed-loop and open loop periods. Furthermore, they will be asked to keep
a diary with SMBGs and insulin dosing when the patient*s standard therapy is
MDI or alterations to the standard insulin settings when the patient uses CSII
as standard therapy. Patients and their caregivers fill out questionnaires on
expectations and treatment satisfaction of the closed-loop system on 3
occasions. There are no major risks associated with this study. The
intervention is a CE-marked device for use in adults. There is no indication to
expect adolescents to respond differently to the closed-loop system compared to
adults. A potential risk might be the administration of an incorrect amount of
insulin or glucagon, which may result in hypo- or hyperglycaemia. This may be
caused by failure of the closed-loop algorithm, technical failure of the system
or incorrect sensor glucose measurements. With multiple risk control measures
the risk for patients is minimized. The system contains a controller and a
separate safety processor, and also several alerts are built in the system. The
patients can be monitored via wireless connection. The individual benefit for
the participating patients is potentially very well regulated glycaemic control
during the test. The potential benefit from this study is however more general;
the continued development and improvement of a portable closed-loop system for
automated glucose control.
Klavermaten 65-5
Goor 7472 DD
NL
Klavermaten 65-5
Goor 7472 DD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with Type 1 Diabetes
- 12-18 years old
- Treated with insulin therapy for at least 6 months
Exclusion criteria
- Impaired awareness of hypoglycaemia (score >= 4) according to Gold and/or
Clarke questionnaire
- BMI >= 35 kg/m2
- Pregnancy and/or breastfeeding
- HbA1c > 97 mmol/mol (11.0%)
- Use of acetaminophen (paracetamol) during the open loop or closed-loop period
- Limited ability to see, hear or feel the alarm signals of the closed-loop
system
- Unwillingness to act in response to the alarm signals
- Living alone during the night during the closed-loop period
- Expected poor internet connectivity regarding 24/7 tele monitoring
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79829.000.22 |