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| Name | Class |
|---|---|
| Rijnstate Hospital | OTHER |
| Inreda Diabetic B.V. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open loop | Active Comparator | 14 days patient-managed Insulin pump therapy (with or without glucose sensor) with blinded continuous glucose monitoring |
|
| Closed loop | Experimental | 4-6 training + 14 days automated blood glucose control with the Artificial pancreas (Inreda Diabetic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump therapy (with or without glucose sensor) | Device | Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in target | Proportion of time spent in the target range (3.9-10 mmol/l) | Week 1-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Time in hypoglycemia 1 | Proportion of time spent in hypoglycemia (<3.9 mmol/l) | Week 1-2 / Week 1 / Week 2 |
| Time in hypoglycemia 2 | Proportion of time spent in hypoglycemia (<3.3 mmol/l) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic variables | Baseline | |
| Weight | Baseline | |
| Length |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J.H. DeVries, MD PhD | Academisch Medisch Centrum, Universiteit van Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | 6815 AD | Netherlands | ||
| Academic Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24224750 | Background | van Bon AC, Luijf YM, Koebrugge R, Koops R, Hoekstra JB, DeVries JH. Feasibility of a portable bihormonal closed-loop system to control glucose excursions at home under free-living conditions for 48 hours. Diabetes Technol Ther. 2014 Mar;16(3):131-6. doi: 10.1089/dia.2013.0166. Epub 2013 Nov 13. | |
| 26996542 | Background |
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|
| Artificial pancreas (Inreda Diabetic) | Device | Bi-hormonal reactive closed loop system without mealtime announcement |
|
|
| Week 1-2 / Week 1 / Week 2 |
| Time in hyperglycemia 1 | Proportion of time spent in hyperglycemia (>10 mmol/l) | Week 1-2 / Week 1 / Week 2 |
| Time in hyperglycemia 2 | Proportion of time spent in hyperglycemia (>13.9 mmol/l) | Week 1-2 / Week 1 / Week 2 |
| Hypoglycemic events | Number of carbohydrate-treated hypoglycemic events | Week 1-2 / Week 1 / Week 2 |
| Mean or median glucose | Mean or median sensor glucose concentration | Week 1-2 / Week 1 / Week 2 |
| Mean or median day glucose | Mean or median sensor glucose concentration | Day time: Week 1-2 / Week 1 / Week 2 |
| Mean or median night glucose | Mean or median sensor glucose concentration | Night time: Week 1-2 / Week 1 / Week 2 |
| Mean or median postprandial glucose | Mean or median sensor glucose concentration | Postprandial: Week 1-2 / Week 1 / Week 2 |
| Glycemic variability 1 | Interquartile range (IQR) | Week 1-2 / Week 1 / Week 2 |
| Glycemic variability 2 | Coefficient of variation (CV) | Week 1-2 / Week 1 / Week 2 |
| Glycemic variability 3 | Low blood glucose index (LBGI) | Week 1-2 / Week 1 / Week 2 |
| Glycemic variability 4 | High blood glucose index (HBGI) | Week 1-2 / Week 1 / Week 2 |
| Glycemic variability 5 | Blood glucose risk index (BGRI) | Week 1-2 / Week 1 / Week 2 |
| Time in target | Proportion of time spent in the target range (3.9-10 mmol/l) | Week 1 / Week 2 |
| PAID: Problem Areas In Diabetes questionnaire | Total score; Scale 0 (no problems) to 80 (big problems) | Baseline / End week 2 |
| EQ5D: EuroQol 5 Dimensions questionnaire | Quality of life measure; Scale 1 ("no problem) to 5 ("extreme problems") | Baseline / End week 2 |
| DTSQ-status: Diabetes Treatment Satisfaction Questionnaire | Total score: Scale 0 (negative) to 36 (positive) | Baseline / End week 2 |
| DTSQ-change: Diabetes Treatment Satisfaction Questionnaire | Change in DTSQ; Total score: Scale -18 (negative) to 18 (positive) | End week 2 |
| Algorithm active time | Percentage of time that the closed loop algorithm is active | Week 1-2 (closed loop only) |
| Usability score | Questionnaire: Mobile Phone Usability Questionnaire (MPUQ); Total score: Scale 62 (low level of usability) to 310 (higher level of usability) | End week 2 (closed loop only) |
| Glucose measurement performance | MARD | Day 3, 4 or 5 of the training period prior to the closed loop |
| Baseline |
| HbA1c plasma concentration | Baseline |
| Meals | Carbohydrate intake | Week 1-2 |
| Physical activity 1 | Number of exercise moments per intensity category ("light", "moderate", "heavy'" ) | Week 1-2 |
| Physical activity 2 | Duration of exercise moments per intensity category ("light", "moderate", "heavy'" ) | Week 1-2 |
| Physical activity 3 | Total number of exercise moments | Week 1-2 |
| Physical activity 4 | Total duration of exercise moments | Week 1-2 |
| Insulin dose | Daily average | Week 1-2 |
| Glucagon dose | Daily average | Week 1-2 |
| Amsterdam |
| North Holland |
| 1105 AZ |
| Netherlands |
| Blauw H, van Bon AC, Koops R, DeVries JH; , on behalf of the PCDIAB consortium. Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home. Diabetes Obes Metab. 2016 Jul;18(7):671-7. doi: 10.1111/dom.12663. Epub 2016 Apr 25. |
| 33397767 | Derived | Blauw H, Onvlee AJ, Klaassen M, van Bon AC, DeVries JH. Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial. Diabetes Care. 2021 Mar;44(3):836-838. doi: 10.2337/dc20-2106. Epub 2021 Jan 4. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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