Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,

Diabetes Mellitus, Type 1 Clinical Trial

— APPEL5  

Official title:

Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 5

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858062
• Other study ID #: NL55693.018.15
• Status: Completed
• Phase: N/A
• Start date: March 10, 2019
• Est. completion date: September 12, 2019

Study information

• Verified date: October 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Insulin pump therapy (with or without glucose sensor)
Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor
• Artificial pancreas (Inreda Diabetic)
Bi-hormonal reactive closed loop system without mealtime announcement

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
J.H. DeVries	Inreda Diabetic, Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic variables		Baseline
Other	Weight		Baseline
Other	Length		Baseline
Other	HbA1c plasma concentration		Baseline
Other	Meals	Carbohydrate intake	Week 1-2
Other	Physical activity 1	Number of exercise moments per intensity category ("light", "moderate", "heavy'"; )	Week 1-2
Other	Physical activity 2	Duration of exercise moments per intensity category ("light", "moderate", "heavy'"; )	Week 1-2
Other	Physical activity 3	Total number of exercise moments	Week 1-2
Other	Physical activity 4	Total duration of exercise moments	Week 1-2
Other	Insulin dose	Daily average	Week 1-2
Other	Glucagon dose	Daily average	Week 1-2
Primary	Time in target	Proportion of time spent in the target range (3.9-10 mmol/l)	Week 1-2
Secondary	Time in hypoglycemia 1	Proportion of time spent in hypoglycemia (<3.9 mmol/l)	Week 1-2 / Week 1 / Week 2
Secondary	Time in hypoglycemia 2	Proportion of time spent in hypoglycemia (<3.3 mmol/l)	Week 1-2 / Week 1 / Week 2
Secondary	Time in hyperglycemia 1	Proportion of time spent in hyperglycemia (>10 mmol/l)	Week 1-2 / Week 1 / Week 2
Secondary	Time in hyperglycemia 2	Proportion of time spent in hyperglycemia (>13.9 mmol/l)	Week 1-2 / Week 1 / Week 2
Secondary	Hypoglycemic events	Number of carbohydrate-treated hypoglycemic events	Week 1-2 / Week 1 / Week 2
Secondary	Mean or median glucose	Mean or median sensor glucose concentration	Week 1-2 / Week 1 / Week 2
Secondary	Mean or median day glucose	Mean or median sensor glucose concentration	Day time: Week 1-2 / Week 1 / Week 2
Secondary	Mean or median night glucose	Mean or median sensor glucose concentration	Night time: Week 1-2 / Week 1 / Week 2
Secondary	Mean or median postprandial glucose	Mean or median sensor glucose concentration	Postprandial: Week 1-2 / Week 1 / Week 2
Secondary	Glycemic variability 1	Interquartile range (IQR)	Week 1-2 / Week 1 / Week 2
Secondary	Glycemic variability 2	Coefficient of variation (CV)	Week 1-2 / Week 1 / Week 2
Secondary	Glycemic variability 3	Low blood glucose index (LBGI)	Week 1-2 / Week 1 / Week 2
Secondary	Glycemic variability 4	High blood glucose index (HBGI)	Week 1-2 / Week 1 / Week 2
Secondary	Glycemic variability 5	Blood glucose risk index (BGRI)	Week 1-2 / Week 1 / Week 2
Secondary	Time in target	Proportion of time spent in the target range (3.9-10 mmol/l)	Week 1 / Week 2
Secondary	PAID: Problem Areas In Diabetes questionnaire	Total score; Scale 0 (no problems) to 80 (big problems)	Baseline / End week 2
Secondary	EQ5D: EuroQol 5 Dimensions questionnaire	Quality of life measure; Scale 1 ("no problem) to 5 ("extreme problems")	Baseline / End week 2
Secondary	DTSQ-status: Diabetes Treatment Satisfaction Questionnaire	Total score: Scale 0 (negative) to 36 (positive)	Baseline / End week 2
Secondary	DTSQ-change: Diabetes Treatment Satisfaction Questionnaire	Change in DTSQ; Total score: Scale -18 (negative) to 18 (positive)	End week 2
Secondary	Algorithm active time	Percentage of time that the closed loop algorithm is active	Week 1-2 (closed loop only)
Secondary	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)
Secondary	Glucose measurement performance	MARD	Day 3, 4 or 5 of the training period prior to the closed loop