Citations 22
SAT-641 Self-Reported Psychological Stress and Glucose Variability in Type 1 Diabetes on Sensor Augmented Pump over 5 Weeks
Kaur, Ravinder Jeet , Pinsker, Jordan E. , Dadlani, Vikash, Thapa, Prabin , Batthula, Sreedhar, Church, Mei Mei , Reid, Corey, Spitzer, Shelly McCrady, Dassau, Eyal , Kudva, Yogish C. , Kremers, Walter K.
Journal of the Endocrine Society | May 8, 2020 | Volume: 4 | Issue: Supplement_1 | Pages: No page available
Abstract Introduction: Patients and their families and medical providers have assumed that psychologic stress impacts glucose control in T1D (Type 1 Diabetes) though studies providing confirmatory evidence in real world settings are, to our knowledge, lacking. We hypothesized that self-reported psychologic stress worsens glucose control in T1D. Method: We studied 20 adults with T1D on continuous glucose monitor (CGM), sensor augmented insulin pump (SAP) prospectively at 2 clinical research centers. Patients reported psychological stress through stress diaries for 5 weeks on a severity scale of 1-7 using hard copy logs including time of onset and offset of stress and severity. For analytic purpose, grades 1-4 are classified as mild and grades 5-7 as severe. Results: Baseline characteristics were age 44.9±15.0 years, F/M 12/8, HbA1c 6.8 ± 0.7%, and diabetes duration of 22.9±15.9 years. We analyzed glucose variability during days of stress versus days without stress. During a 24 hour period, patients experienced less hypoglycemia during days with stress versus days without stress (p value 0.03). During the 5 week period, patients reported 23 ± 19.5 events. We analyzed the impact of self-reported stress on CGM data streams after excluding stress events associated with missing CGM data, nocturnal events (from 12 MN to 6 AM, too few events) and events for which subjects did not provide duration of stress. Thus, we analyzed 19.5 ± 17 events per patient from 6AM to 12MN. From 6 AM to 12 MN, the episodes lasted 179 ± 255 minutes with 83 % episodes being mild/moderate and 17% moderate/ severe. Number of CGM readings during daytime stress episodes were 717± 1120 compared to 8768± 1238 during non-stress periods. Impact of stress from 6 AM to 12 MN (Mid-Night) on CGM glucose was analyzed using matched paired t test. Mean glucose (160.6±41.9 vs 148.3± 28.6) and SD (53.2 ±17.7 vs 56.1±14.6) did not show a difference; however % of time spent below 70 mg/dl was less (4 ± 5) in patients during stressful periods compared to times without stress (6.3± 5.5, P value 0.02). Conclusions: To our knowledge, this is the first study attempting to analyze the impact of self-reported stress using daily stress diaries on CGM data streams in T1D patients on SAP. The study revealed significant challenges experienced by patients in reporting adequate data. Self-reported stress was not associated with hyperglycemia. However, days of self-reported stress and periods during patients reported stress were characterized by less hypoglycemia on CGM data streams.
Randomized Controlled Trial of Mobile Closed-Loop Control
Kovatchev, Boris , Anderson, Stacey M. , Raghinaru, Dan, Kudva, Yogish C. , Laffel, Lori M. , Pinsker, Jordan E. , Buckingham, Bruce A. , Doyle, Francis J. , Brown, Sue A. , Church, Mei Mei , Dadlani, Vikash, Dassau, Eyal , Ekhlaspour, Laya , Forlenza, Gregory P. , Isganaitis, Elvira , Lam, David W. , Lum, John W. , Group, iDCL Study, Emory, Emma, Voelmle, Mary, Conshafter, Katie, Morris, Kim, Mitchell, Harry, Calvo, Kayla, Wakeman, Christian, Breton, Marc D. , Ambler-Osborn, Louise, Flint, Emily, Schultz, Alan , Kim, Kenny, Church, Mei Mei, André, Camille , Lam, David W., O’Malley, Grenye , Levister, Camilla, Ogyaadu, Selassie, Simha, Vinaya , McCrady-Spitzer, Shelly , Reid, Corey, Jost, Emily , Berget, Cari , Towers, Lindsey, Buckingham, Bruce, Ekhlaspour, Laya, Hsu, Liana, Loebner, Sarah E., Doyle, Francis J., Campos, Tiffany, Passman, Samantha, Murphy, Carlos, Patibandla, Nandan, Kollman, Craig, Pinsker, Jordan E , Doyle, Francis J , Dassau, Eyal , Ekhlaspour, Laya , Forlenza, Gregory P , Lum, John , Kovatchev, Boris , Buckingham, Bruce , Levy, Carol J. , Wadwa, R Paul , Beck, Roy W. , Group, iDCL Study, Oliveri, Mary Clancy , Church, Mei Mei, Lam, David W., Messer, Laurel H , Buckingham, Bruce, Ekhlaspour, Laya, Doyle, Francis J., Kollman, Craig
Diabetes Care | January 15, 2020 | Volume: 43 | Issue: 3 | Pages: 607-615
OBJECTIVE Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND METHODS This protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)–measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. RESULTS Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (n = 65) versus SAP (n = 62); 125 participants completed the study. CGM time below 3.9 mmol/L was 5.0% at baseline and 2.4% during follow-up in the CLC group vs. 4.7% and 4.0%, respectively, in the SAP group (mean difference −1.7% [95% CI −2.4, −1.0]; P < 0.0001 for superiority). CGM time above 10 mmol/L was 40% at baseline and 34% during follow-up in the CLC group vs. 43% and 39%, respectively, in the SAP group (mean difference −3.0% [95% CI −6.1, 0.1]; P < 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device. CONCLUSIONS In meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.