Type 1 Diabetes Mellitus Clinical Trial
Official title:
Feasibility Study of a Modular Control to Range System in T1DM
In this protocol the investigators plan to demonstrate the feasibility of a modular insulin
management system based on continuous glucose monitoring and targeted towards the avoidance
of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol
is designed to challenge the insulin management system with meals and mild exercise, so as
to demonstrate its capacity to avoid large glucose excursion with changing metabolic state.
This system is designed to both
- monitor the meal boluses of the patient and correct it in case of observed/predicted
under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and
subjective knowledge of the meal amount, a precise understanding of the subject's day
to day insulin treatment, continuous glucose monitoring, and past insulin injections;
- predict and avoid hypoglycemic events, based on continuous glucose reading and past
insulin injection.
The investigators plan to enroll 12 adult Type 1 Diabetes Mellitus (T1DM) patients (expected
retention 10/12) and compare glucose control performances under two treatments: standard vs.
the new insulin management system. The protocol will include a total of 6 admissions per
subject (4 out-patients and 2 in-patients): screening, effort test, CGM insertion 1,
inpatient 1, CGM insertion 2, and inpatient 2. During the 24h inpatient admissions, the
patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage
of these events will vary depending on the chosen treatment, each subject will be exposed to
both studied treatments (repeated measure design).The order of treatment during the
inpatient admissions will be randomized.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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