Clinical trial NCT03858062: Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,
Official title: Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 5
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Artificial pancreas
Glucose control
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
name: Inreda Diabetic B.V.
First posted: 2019-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time in target
timeFrame: Week 1-2
Secondary outcomes:
measure: Time in hypoglycemia 1
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Time in hypoglycemia 2
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Time in hyperglycemia 1
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Time in hyperglycemia 2
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Hypoglycemic events
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Mean or median glucose
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Mean or median day glucose
timeFrame: Day time: Week 1-2 / Week 1 / Week 2
measure: Mean or median night glucose
timeFrame: Night time: Week 1-2 / Week 1 / Week 2
measure: Mean or median postprandial glucose
timeFrame: Postprandial: Week 1-2 / Week 1 / Week 2
measure: Glycemic variability 1
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Glycemic variability 2
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Glycemic variability 3
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Glycemic variability 4
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Glycemic variability 5
timeFrame: Week 1-2 / Week 1 / Week 2
measure: Time in target
timeFrame: Week 1 / Week 2
measure: PAID: Problem Areas In Diabetes questionnaire
timeFrame: Baseline / End week 2
measure: EQ5D: EuroQol 5 Dimensions questionnaire
timeFrame: Baseline / End week 2
measure: DTSQ-status: Diabetes Treatment Satisfaction Questionnaire
timeFrame: Baseline / End week 2
measure: DTSQ-change: Diabetes Treatment Satisfaction Questionnaire
timeFrame: End week 2
measure: Algorithm active time
timeFrame: Week 1-2 (closed loop only)
measure: Usability score
timeFrame: End week 2 (closed loop only)
measure: Glucose measurement performance
timeFrame: Day 3, 4 or 5 of the training period prior to the closed loop
Other outcomes:
measure: Demographic variables
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Length
timeFrame: Baseline
measure: HbA1c plasma concentration
timeFrame: Baseline
measure: Meals
timeFrame: Week 1-2
measure: Physical activity 1
timeFrame: Week 1-2
measure: Physical activity 2
timeFrame: Week 1-2
measure: Physical activity 3
timeFrame: Week 1-2
measure: Physical activity 4
timeFrame: Week 1-2
measure: Insulin dose
timeFrame: Week 1-2
measure: Glucagon dose
timeFrame: Week 1-2
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum, Universiteit van Amsterdam
name: J.H. DeVries, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.