To determine the long-term clinical effectiveness of treatment with a dual-hormone (insulin and glucagon) fully closed loop system during 12 months compared to the current most used care and to the currently most advanced technological care.…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the Time in Range (TIR; % of time spent in the
3.9-10 mmol/l target range) at 12 months, which will be compared between the
intervention and the control treatment within each arm.
Secondary outcome
Secondary endpoints include cost-effectiveness, PROMs, other glycaemic
outcomes, safety measures and device-related outcomes.
Background summary
Patients with type 1 diabetes mellitus (T1DM) require lifelong insulin therapy.
Insulin therapy improves but does not fully normalise blood glucose levels with
current therapies. Current therapies include subcutaneous insulin injection or
subcutaneous insulin infusion, combined with a device to measure glucose levels
(finger stick, intermittent sensor or continuous glucose monitoring). Although
having provided a huge improvement in glycaemic control, patients have to work
hard every day and still have to calculate mealtime boluses. An automated
insulin delivery device covering both basal and prandial insulin requirement
would mean another great leap forwards. The dual-hormone fully closed loop
(DHFCL) provides a new strategy of automated insulin delivery (coupled with
targeted glucagon infusion as insulin-antagonist to even more approximate
normal physiology).
Study objective
To determine the long-term clinical effectiveness of treatment with a
dual-hormone (insulin and glucagon) fully closed loop system during 12 months
compared to the current most used care and to the currently most advanced
technological care. Secondary objectives include the assessment of
cost-effectiveness, Patient Reported Outcome Measures (PROMs), other glycaemic
outcomes and safety.
Study design
A 12 month open-label, two-arm randomised parallel-group trial.
Intervention
1 group will use the dual hormone fully closed loop (Inreda Diabetic; CE
marked). The other group will continue their regular treatment.
Study burden and risks
There are no major risks associated with this study. The most prominent risk is
failure of the closed loop to regulate the plasma glucose concentration
properly, which can result in hypo- or hyperglycaemia. However, with multiple
risk control measures the risk for the patients is minimized. The dual hormone
fully closed loop (DHFCL) has several benefits for patients compared to current
therapies. Clinical studies have shown that the DHFCL system provides better
glycaemic control than insulin pump therapy, resulting in a higher percentage
TIR. The DHFCL system completely takes over the glucose regulation, thereby
relieving patients with regard to counting carbohydrates, estimating the amount
of insulin to be administered, and taking into account future activities for
glucose control.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
• Age between 18 and 75 years;
• Diagnosed with type 1 diabetes mellitus at least one year ago;
• HbA1c <= 91 mmol/mol;
Exclusion criteria
• Current use of non-approved hybrid closed loop device;
• BMI >35 kg/m2;
• eGFR<30 mL/min/1.73m2;
• Plan to change usual diabetes regimen in the next 3 months;
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 | NL81500.041.23 |