Diabetes Mellitus, Type 1
Conditions
Keywords
Artificial pancreas, Glucose control
Brief summary
In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.
Interventions
DEVICEInsulin pump therapy (with or without glucose sensor)
Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor
DEVICEArtificial pancreas (Inreda Diabetic)
Bi-hormonal reactive closed loop system without mealtime announcement
Sponsors
Rijnstate Hospital
Inreda Diabetic B.V.
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 SAP or CSII for a minimum of 6 months; * 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; * Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements; * Limited ability to see, and to hear or feel alarm signals of the closed loop system; * Skin condition prohibiting needle insertion; * Pregnancy and/or breastfeeding; * Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily); * Expected poor connectivity with internet regarding 24/7 tele monitoring; * 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 | Description |
|---|---|---|
| Time in target | Week 1-2 | Proportion of time spent in the target range (3.9-10 mmol/l) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic events | Week 1-2 / Week 1 / Week 2 | Number of carbohydrate-treated hypoglycemic events |
| Glycemic variability 1 | Week 1-2 / Week 1 / Week 2 | Interquartile range (IQR) |
| Glycemic variability 2 | Week 1-2 / Week 1 / Week 2 | Coefficient of variation (CV) |
| Glycemic variability 3 | Week 1-2 / Week 1 / Week 2 | Low blood glucose index (LBGI) |
| Glycemic variability 4 | Week 1-2 / Week 1 / Week 2 | High blood glucose index (HBGI) |
| Glycemic variability 5 | Week 1-2 / Week 1 / Week 2 | Blood glucose risk index (BGRI) |
| Time in target | Week 1 / Week 2 | Proportion of time spent in the target range (3.9-10 mmol/l) |
| PAID: Problem Areas In Diabetes questionnaire | Baseline / End week 2 | Total score; Scale 0 (no problems) to 80 (big problems) |
| EQ5D: EuroQol 5 Dimensions questionnaire | Baseline / End week 2 | Quality of life measure; Scale 1 (no problem) to 5 (extreme problems) |
| Algorithm active time | Week 1-2 (closed loop only) | Percentage of time that the closed loop algorithm is active |
| Usability score | End week 2 (closed loop only) | Questionnaire: Mobile Phone Usability Questionnaire (MPUQ); Total score: Scale 62 (low level of usability) to 310 (higher level of usability) |
| Glucose measurement performance | Day 3, 4 or 5 of the training period prior to the closed loop | MARD |
| Time in hypoglycemia 1 | Week 1-2 / Week 1 / Week 2 | Proportion of time spent in hypoglycemia (\<3.9 mmol/l) |
| Time in hypoglycemia 2 | Week 1-2 / Week 1 / Week 2 | Proportion of time spent in hypoglycemia (\<3.3 mmol/l) |
| Time in hyperglycemia 1 | Week 1-2 / Week 1 / Week 2 | Proportion of time spent in hyperglycemia (\>10 mmol/l) |
| DTSQ-status: Diabetes Treatment Satisfaction Questionnaire | Baseline / End week 2 | Total score: Scale 0 (negative) to 36 (positive) |
| DTSQ-change: Diabetes Treatment Satisfaction Questionnaire | End week 2 | Change in DTSQ; Total score: Scale -18 (negative) to 18 (positive) |
| Time in hyperglycemia 2 | Week 1-2 / Week 1 / Week 2 | Proportion of time spent in hyperglycemia (\>13.9 mmol/l) |
| Mean or median glucose | Week 1-2 / Week 1 / Week 2 | Mean or median sensor glucose concentration |
| Mean or median day glucose | Day time: Week 1-2 / Week 1 / Week 2 | Mean or median sensor glucose concentration |
| Mean or median night glucose | Night time: Week 1-2 / Week 1 / Week 2 | Mean or median sensor glucose concentration |
| Mean or median postprandial glucose | Postprandial: Week 1-2 / Week 1 / Week 2 | Mean or median sensor glucose concentration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length | Baseline | — |
| HbA1c plasma concentration | Baseline | — |
| Meals | Week 1-2 | Carbohydrate intake |
| Physical activity 1 | Week 1-2 | Number of exercise moments per intensity category (light, moderate, heavy' ) |
| Physical activity 2 | Week 1-2 | Duration of exercise moments per intensity category (light, moderate, heavy' ) |
| Physical activity 3 | Week 1-2 | Total number of exercise moments |
| Physical activity 4 | Week 1-2 | Total duration of exercise moments |
| Insulin dose | Week 1-2 | Daily average |
| Glucagon dose | Week 1-2 | Daily average |
| Demographic variables | Baseline | — |
| Weight | Baseline | — |
Countries
Netherlands
Outcome results
None listed