Diabetes Mellitus, Type 1
Conditions
Keywords
Artificial pancreas, Bi-hormonal closed loop, Diabetes Type 1
Brief summary
In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. Glucose control with automated closed loop control was comparable to patient-managed open loop control. The closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. The aim of this trial is to assess the efficacy of the new prototype at the home of the patient. It is hypothesized that the closed loop system provides better glucose control than standard open loop therapy.
Interventions
DEVICEArtificial Pancreas (Inreda Diabetic BV)
Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype
DEVICEInsulin pump therapy
Patients' own insulin pump with fast-acting insulin analog
Sponsors
European Commission
Rijnstate Hospital
J.H. DeVries
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with diabetes mellitus type 1 * Treated with insulin pump therapy for a minimum of 6 months * Age between 18 and 75 years * 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 * Skin condition prohibiting needle insertion * Pregnancy and/or breastfeeding * Living alone during the closed loop period (the patient may ask someone to stay over temporarily) * Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean sensor glucose concentration | Day 2-4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l) | Day 2-4 | — |
| Mean absolute relative difference between sensor values and self-monitored blood glucose values | Day 2-4 | — |
| Heart rate | Day 2-4 | — |
| Physical activity | Day 2-4 | Acceleration measured with a tri-axial accelerometer. The physical activity parameter is calculated as the magnitude of the total acceleration vector (square root of the sum of the squared axes). |
| Mean glucose concentration per day | Day 1-4 | Intervention arm (closed loop) only |
| Time that the control algorithm is inactive | Day 1-4 | Intervention arm (closed loop) only |
| Proportion of time spent in each glycemic category | Day 2-4 | Glycemic categories: * Low glucose (\<3.9 mmol/l and ≥ 3.3 mmol/l) * Very low glucose (\<3.3 mmol/l and ≥ 2.8 mmol/l) * Dangerously low glucose (\<2.8 mmol/l) * High glucose (\> 10 mmol/l and ≤ 13.9 mmol/l) * Very high glucose (\> 13.9 mmol/l and ≤ 22.2 mmol/) * Dangerously high glucose (\> 22.2 mmol/l) |
| Number of events in each glycemic category | Day 2-4 | Glycemic categories: * Low glucose (\<3.9 mmol/l and ≥ 3.3 mmol/l) * Very low glucose (\<3.3 mmol/l and ≥ 2.8 mmol/l) * Dangerously low glucose (\<2.8 mmol/l) * High glucose (\> 10 mmol/l and ≤ 13.9 mmol/l) * Very high glucose (\> 13.9 mmol/l and ≤ 22.2 mmol/) * Dangerously high glucose (\> 22.2 mmol/l) |
| Number of carbohydrate-treated hypoglycemic events | Day 2-4 | — |
| Glycemic variability | Day 2-4 | Calculated as Interquartile Range (IQR) |
| Mean sensor glucose concentration during specific periods | Day 2-4 | Periods: * Day * Night * Postprandial |
Other
| Measure | Time frame |
|---|---|
| Length | Baseline |
| Insulin use | Day 1-4 |
| Glucagon use | Day 1-4 |
| Weight | Baseline |
| Demographic characteristics | Baseline |
Countries
Netherlands
Outcome results
None listed