Abstract
Background: Use of artificial pancreas (AP) requires seamless interaction of device components, such as continuous glucose monitor (CGM), insulin pump, and control algorithm. Mobile AP configurations also include a smartphone as computational hub and gateway to cloud applications (e.g., remote monitoring and data review and analysis). This International Diabetes Closed-Loop study was designed to demonstrate and evaluate the operation of the inControl AP using different CGMs and pump modalities without changes to the user interface, user experience, and underlying controller. Methods: Forty-three patients with type 1 diabetes (T1D) were enrolled at 10 clinical centers (7 United States, 3 Europe) and 41 were included in the analyses (39% female, >95% non-Hispanic white, median T1D duration 16 years, median HbA1c 7.4%). Two CGMs and two insulin pumps were tested by different study participants/sites using the same system hub (a smartphone) during 2 weeks of in-home use. Results: The major difference between the system components was the stability of their wireless connections with the smartphone. The two sensors achieved similar rates of connectivity as measured by percentage time in closed loop (75% and 75%); however, the two pumps had markedly different closed-loop adherence (66% vs. 87%). When connected, all system configurations achieved similar glycemic outcomes on AP control (73% [mean] time in range: 70-180 mg/dL, and 1.7% [median] time <70 mg/dL). Conclusions: CGMs and insulin pumps can be interchangeable in the same Mobile AP system, as long as these devices achieve certain levels of reliability and wireless connection stability.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 73-80 |
| Number of pages | 8 |
| Journal | Diabetes Technology and Therapeutics |
| Volume | 21 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 1 2019 |
Fingerprint
Keywords
- Continuous glucose monitor use
- Insulin pump use
- International Diabetes Closed-Loop Study
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Endocrinology
- Medical Laboratory Technology
Cite this
The International Diabetes Closed-Loop Study : Testing Artificial Pancreas Component Interoperability. / Anderson, Stacey M.; Dassau, Eyal; Raghinaru, Dan; Lum, John; Brown, Sue A.; Pinsker, Jordan E.; Church, Mei Mei; Levy, Carol; Lam, David; Kudva, Yogish C; Buckingham, Bruce; Forlenza, Gregory P.; Wadwa, R. Paul; Laffel, Lori; Doyle, Francis J.; Hans Devries, J.; Renard, Eric; Cobelli, Claudio; Boscari, Federico; Del Favero, Simone; Kovatchev, Boris P.
In: Diabetes Technology and Therapeutics, Vol. 21, No. 2, 01.02.2019, p. 73-80.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The International Diabetes Closed-Loop Study
T2 - Testing Artificial Pancreas Component Interoperability
AU - Anderson, Stacey M.
AU - Dassau, Eyal
AU - Raghinaru, Dan
AU - Lum, John
AU - Brown, Sue A.
AU - Pinsker, Jordan E.
AU - Church, Mei Mei
AU - Levy, Carol
AU - Lam, David
AU - Kudva, Yogish C
AU - Buckingham, Bruce
AU - Forlenza, Gregory P.
AU - Wadwa, R. Paul
AU - Laffel, Lori
AU - Doyle, Francis J.
AU - Hans Devries, J.
AU - Renard, Eric
AU - Cobelli, Claudio
AU - Boscari, Federico
AU - Del Favero, Simone
AU - Kovatchev, Boris P.
PY - 2019/2/1
Y1 - 2019/2/1
N2 - Background: Use of artificial pancreas (AP) requires seamless interaction of device components, such as continuous glucose monitor (CGM), insulin pump, and control algorithm. Mobile AP configurations also include a smartphone as computational hub and gateway to cloud applications (e.g., remote monitoring and data review and analysis). This International Diabetes Closed-Loop study was designed to demonstrate and evaluate the operation of the inControl AP using different CGMs and pump modalities without changes to the user interface, user experience, and underlying controller. Methods: Forty-three patients with type 1 diabetes (T1D) were enrolled at 10 clinical centers (7 United States, 3 Europe) and 41 were included in the analyses (39% female, >95% non-Hispanic white, median T1D duration 16 years, median HbA1c 7.4%). Two CGMs and two insulin pumps were tested by different study participants/sites using the same system hub (a smartphone) during 2 weeks of in-home use. Results: The major difference between the system components was the stability of their wireless connections with the smartphone. The two sensors achieved similar rates of connectivity as measured by percentage time in closed loop (75% and 75%); however, the two pumps had markedly different closed-loop adherence (66% vs. 87%). When connected, all system configurations achieved similar glycemic outcomes on AP control (73% [mean] time in range: 70-180 mg/dL, and 1.7% [median] time <70 mg/dL). Conclusions: CGMs and insulin pumps can be interchangeable in the same Mobile AP system, as long as these devices achieve certain levels of reliability and wireless connection stability.
AB - Background: Use of artificial pancreas (AP) requires seamless interaction of device components, such as continuous glucose monitor (CGM), insulin pump, and control algorithm. Mobile AP configurations also include a smartphone as computational hub and gateway to cloud applications (e.g., remote monitoring and data review and analysis). This International Diabetes Closed-Loop study was designed to demonstrate and evaluate the operation of the inControl AP using different CGMs and pump modalities without changes to the user interface, user experience, and underlying controller. Methods: Forty-three patients with type 1 diabetes (T1D) were enrolled at 10 clinical centers (7 United States, 3 Europe) and 41 were included in the analyses (39% female, >95% non-Hispanic white, median T1D duration 16 years, median HbA1c 7.4%). Two CGMs and two insulin pumps were tested by different study participants/sites using the same system hub (a smartphone) during 2 weeks of in-home use. Results: The major difference between the system components was the stability of their wireless connections with the smartphone. The two sensors achieved similar rates of connectivity as measured by percentage time in closed loop (75% and 75%); however, the two pumps had markedly different closed-loop adherence (66% vs. 87%). When connected, all system configurations achieved similar glycemic outcomes on AP control (73% [mean] time in range: 70-180 mg/dL, and 1.7% [median] time <70 mg/dL). Conclusions: CGMs and insulin pumps can be interchangeable in the same Mobile AP system, as long as these devices achieve certain levels of reliability and wireless connection stability.
KW - Continuous glucose monitor use
KW - Insulin pump use
KW - International Diabetes Closed-Loop Study
UR - http://www.scopus.com/inward/record.url?scp=85060912327&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85060912327&partnerID=8YFLogxK
U2 - 10.1089/dia.2018.0308
DO - 10.1089/dia.2018.0308
M3 - Article
C2 - 30649925
AN - SCOPUS:85060912327
VL - 21
SP - 73
EP - 80
JO - Diabetes Technology and Therapeutics
JF - Diabetes Technology and Therapeutics
SN - 1520-9156
IS - 2
ER -