Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: Insulin pump therapyDevice: Artificial Pancreas (Inreda Diabetic BV)
- Registration Number
- NCT02160275
- Lead Sponsor
- J.H. DeVries
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Open Loop Insulin pump therapy 4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring Closed Loop Artificial Pancreas (Inreda Diabetic BV) 4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)
- Primary Outcome Measures
Name Time Method Mean sensor glucose concentration Day 2-4
- Secondary Outcome Measures
Name Time Method Mean sensor glucose concentration during specific periods Day 2-4 Periods:
* Day
* Night
* PostprandialNumber of carbohydrate-treated hypoglycemic events Day 2-4 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)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)Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l) Day 2-4 Glycemic variability Day 2-4 Calculated as Interquartile Range (IQR)
Mean absolute relative difference between sensor values and self-monitored blood glucose values Day 2-4 Heart rate Day 2-4 Time that the control algorithm is inactive Day 1-4 Intervention arm (closed loop) only
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
Trial Locations
- Locations (2)
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands
Academic Medical Center
🇳🇱Amsterdam, Noord-Holland, Netherlands