Automated Insulin Delivery (AID) hybrid closed-loop systems have not been well studied in the context of prescribed meals. We evaluated our interoperable artificial pancreas system (iAPS) with ...scheduled meal challenges in a randomized crossover trial in an at-home setting.
Ten adults with type 1 diabetes completed two weeks of AID-based control and two weeks of conventional therapy (sensor-augmented pump/predictive low-glucose suspend) at home in random order. During each period, subjects consumed pasta or white rice as part of a complete dinner meal on six different occasions (each meal three times in random order).
The AID system increased time in range 70-180 mg/dL from 70.6 to 74.0% (3.4, 95% CI -2.3 to 9.1, p=0.22), while sensor time <70 mg/dL significantly decreased from 3.5 to 2.3% (-1.2, 95% CI -2.1 to -0.2, p=0.02). Postprandial glucose AUC difference between meals in conventional therapy was 10,919.0 mg/dL x min (95% CI 3,190.5 to 18,648.0, p=0.009) while for AID it was 6,522.1 mg/dL x min (p=0.24), highlighting the ability of AID to minimize glycemic excursions postprandially. The AID system decreased insulin delivery at 0-2h by 0.45 units (p=0.001) for pasta, while it increased at 2-4h by 0.47 units (p=0.18) for white rice (Table 1).
The AID system improved postprandial glucose control over conventional therapy in the handling of challenging meals in the at-home setting.
Disclosure
J.E. Pinsker: Advisory Panel; Self; Medtronic. Consultant; Self; Eli Lilly and Company, Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Tandem Diabetes Care. Speaker’s Bureau; Self; Tandem Diabetes Care. S. Deshpande: None. M. Church: None. M. Piper: None. C.C. Andre: None. J.S. Massa: None. F.J. Doyle: Research Support; Self; DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Mode AGC. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. D.M. Eisenberg: Consultant; Self; Barilla Center For Food and Nutrition, Italy. E. Dassau: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; Roche Diabetes Care. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care.
Funding
Barilla Center for Food & Nutrition Foundation; National Institutes of Health (DP3DK104057, DP3DK113511); Harvard Accelerator; Dexcom, Inc. (IIS-2018-019)
Pregnancy complicated by type 1 diabetes (T1D) is associated with increased maternal and fetal morbidity and mortality. We report results from the first clinical trial testing a closed-loop control ...(CLC) system specifically designed for pregnant women with T1D in the United States. Eight pregnant women with T1D participated in a 48-hour clinical trial at three US sites (NCT04492566). Women were enrolled in the second trimester after organogenesis was completed. CLC sessions used the interoperable artificial pancreas system (iAPS) running a Zone-Model Predictive Control algorithm designed for stricter glycemic targets for pregnancy. Glycemic target zones were 80-110 mg/dL during the day and 80-100 mg/dL overnight, with assertive insulin delivery in the postprandial period. The primary outcome was sensor glucose time in range (TIR) for pregnancy 63-140 mg/dL as per international consensus guidelines. All enrolled subjects completed the trial. Participants had a mean age of 29.3±3.5 years, gestational age of 22.2±3.6 weeks, weight of 77±12.2 kg, and HbA1c of 5.7±0.5%. Mean sensor TIR 63-140 mg/dL was 79.3±12.8% during CLC, compared to 60.8±18.8% for the week prior in open loop at home (p=0.03, Table 1). Unrestricted carbohydrate intake at meals ranged from 7 to 78 grams during the CLC sessions. No severe hypoglycemia or adverse events occurred. CLC in pregnant women with T1D is safe and effective.
Aim
Parents of children born preterm have identified outcomes to be measured for audit and research at 18–24 months of age: child well‐being, quality of life/function, socio‐emotional/behavioural ...outcomes, respiratory, feeding, sleeping, and caregiver mental health. The aim was to identify the best tools to measure these seven domains.
Methods
Seven working groups completed literature reviews and evaluated potential tools to measure these outcomes in children aged 18–24 months. A group of experts and parents voted on the preferred tools in a workshop and by questionnaire. Consensus was 80% agreement.
Results
Consensus was obtained for seven brief, inexpensive, parent friendly valid measures available in English or French for use in a minimum dataset and potential alternative measures for use in funded research.
Conclusion
Valid questionnaires and tools to measure parent‐identified outcomes in young preterm children exist. This study will facilitate research and collection of data important to families.
Pregnancies in type 1 diabetes (T1D) are high-risk, and data in the U.S. are limited regarding clinical and CGM based hypoglycemia throughout pregnancy while on sensor augmented insulin pump (SAP). ...Pregnant women with T1D on insulin pump ≤ 16 wks gestation were enrolled at 3 U.S. centers and used study Dexcom G6. We analyzed episodes of severe hypoglycemia (SH) and days with > 20 hrs of CGM for biochemical hypoglycemia (BH) based on international consensus guidelines (<63 and <54 mg/dl) and frequency/duration of prolonged hypoglycemia (PH, ≥120 mins < 54 mg/dl) Twenty pregnant subjects, age 31 ± 4.5 yrs, 14 ± 8 yrs of T1D, baseline weight 77 ± 16 kg, BMI 28 ± 6.2 kg/m2, HbA1c 6.5 ± 0.7%, were studied. Gestational age at enrollment and delivery was 11.4 ± 4 and 37.7 ± 1.5 wks respectively. One subject experienced a single episode of SH with an overall incidence 7/100 patient years. Percentage of hypoglycemia and BH events per trimester are described in Table 1. BH was common in each trimester, but most frequent in the first. Eighteen events of PH occurred in four subjects (20%) lasting 120-410 mins with two events each in two, three events in one and 11 events in one subject respectively with 15 (83%) events occurring between 12am-6am. Our study shows pregnant women with T1D on SAP frequently experience level 1 hypoglycemia, and 20% experience prolonged hypoglycemia predominantly overnight.
Disclosure
R. Kaur: None. B.H. Smith: None. J.E. Pinsker: Advisory Panel; Self; Medtronic. Consultant; Self; Eli Lilly and Company, Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Tandem Diabetes Care. Speaker’s Bureau; Self; Tandem Diabetes Care. B. Ozaslan: None. G. O’Malley: Research Support; Self; Abbott, Dexcom, Inc. M. Trinidad: None. D. Desjardins: None. K.N. Castorino: Research Support; Self; Abbott, Dexcom, Inc., Medtronic, Mylan, Novo Nordisk Inc. C. Levister: None. C. Reid: None. S.K. McCrady-Spitzer: None. S.J. Ogyaadu: None. M. Church: None. M. Piper: None. W.K. Kremers: Research Support; Self; AstraZeneca. B. Rosenn: None. C.J. Levy: Consultant; Self; Dexcom, Inc. Employee; Spouse/Partner; Allergan plc. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation. E. Dassau: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; Roche Diabetes Care. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. Y.C. Kudva: Research Support; Self; Dexcom, Inc., Roche Diabetes Care. Other Relationship; Self; Abbott.
Funding
National Institutes of Health (122358); Dexcom, Inc. (AP-2018-016)
There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We ...designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can interface wirelessly with leading continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms while running on an unlocked smartphone.
After algorithm verification, hazard and mitigation analysis, and complete system verification of iAPS, six adults with type 1 diabetes completed 1 week of sensor-augmented pump (SAP) use followed by 48 h of AP use with the iAPS, a Dexcom G5 CGM, and either a Tandem or Insulet insulin pump in an investigational device exemption study. The AP system was challenged by participants performing extensive walking without exercise announcement to the controller, multiple large meals eaten out at restaurants, two overnight periods, and multiple intentional connectivity interruptions.
Even with these intentional challenges, comparison of the SAP phase with the AP study showed a trend toward improved time in target glucose range 70-180 mg/dL (78.8% vs. 83.1%; P = 0.31), and a statistically significant reduction in time below 70 mg/dL (6.1% vs. 2.2%; P = 0.03). The iAPS system performed reliably and showed robust connectivity with the peripheral devices (99.8% time connected to CGM and 94.3% time in closed loop) while requiring limited user intervention.
The iAPS system was safe and effective in regulating glucose levels under challenging conditions and is suitable for use in unconstrained environments.
Objective: There have been no clear data describing the association between acute psychological stress and glycemic variability (GV) in people with type 1 diabetes (T1D). Patients self-report that ...acute stress leads to hyperglycemia.
Methods: Twenty adults with T1D on CGM augmented insulin pump completed self-reported psychological stress diaries for a period of 5 weeks at 2 clinical research centers. Participants reported intensity of stress on a 7-point scale, with 1 indicating mild stress and 7 severe stress, and duration of each stress episode. CGM data were analyzed for week 1 and week 5.
Results: Baseline characteristics were age 44.9±15.0 years, F/M 12/8, HbA1c 6.8±0.7%, and diabetes duration 22.9±15.9 years. Total number of stress events reported was 126 over the two-week period. Subjects reported stress on average of 9±2.2 days representing 64.2%±28.2% of days. GV was compared on days of stress vs. days without stress for each subject. Mean BG did not differ; however, % time spent above 250 mg/dl was less in patients who did not report stress events during the day (6.1± 9.8%) compared to patients with stressful episodes (10.1±17.6%) (p=0.02) (Table).
Discussion: Acute stress in patients with T1D was associated with certain measures of GV. We are currently analyzing GV based on duration and intensity of stress and the time between reported stress and change in glucose.
Disclosure
V. Dadlani: None. J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Tandem Diabetes Care. K. Kumari: None. C.C. Andre: None. M. Cescon: None. C. Reid: None. S.K. McCrady-Spitzer: None. P. Thapa: None. M. Church: None. D. Choudhary: None. F.J. Doyle: Consultant; Self; ModeAGC. Other Relationship; Self; Insulet Corporation. E. Dassau: Consultant; Self; Eli Lilly and Company, Insulet Corporation. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Ltd., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; Roche Diabetes Care. Other Relationship; Self; ModAGC. Y.C. Kudva: Advisory Panel; Self; Novo Nordisk Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care.
Funding
JDRF; The Leona M. and Harry B. Helmsley Charitable Trust (2-SRA-2017-503-M-B); Dexcom, Inc. (IIS-2017-043)
Background: Food choices are essential to successful glycemic control in persons with diabetes.
Methods: Twelve adults with type 1 diabetes (T1D) (age 58.7±14.2 years, HbA1c 7.5±1.3%) completed an ...in-clinic double-blinded crossover study comparing the glycemic response to higher protein pasta (10 grams protein/serving), regular pasta (7 grams protein/serving), and white rice. All meals contained 42 grams carbohydrate, were served with homemade tomato sauce, green salad and balsamic dressing, and were repeated in random order. Linear mixed effects models assessed the 5 h postprandial glycemic response.
Results: Compared to white rice, peak glucose levels were significantly lower for higher protein pasta (-32.6 mg/dL; 95% CI -48.4, -17.2; p<0.001) and for regular pasta (-43.2 mg/dL, 95% CI -58.7, -27.7; p<0.001). The difference between the two types of pastas did not reach statistical significance (-11 mg/dL; 95% CI -24.1, 3.4; p=0.17). Total glucose area under the curve for the 5 h postprandial period was significantly higher for white rice compared to both pastas (p<0.001) (Table 1).
Conclusions: There is a significant difference in postprandial glycemic response in persons with T1D between rice and both types of pasta when consumed in equal amounts of carbohydrate. Persons with T1D need to be aware of the relative impact of commonly consumed carbohydrates in the setting of real-life meals.
Disclosure
J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Tandem Diabetes Care. S. Zavitsanou: Employee; Self; Novo Nordisk A/S. J.S. Massa: None. S. Deshpande: None. M. Church: None. C.C. Andre: None. F.J. Doyle: Consultant; Self; ModeAGC. Other Relationship; Self; Insulet Corporation. A. Michelson: None. J. Creason: None. E. Dassau: Consultant; Self; Eli Lilly and Company, Insulet Corporation. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Ltd., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; Roche Diabetes Care. Other Relationship; Self; ModAGC. D.M. Eisenberg: Advisory Panel; Self; Barilla Center for Food & Nutrition Foundation. Consultant; Self; Campus for H (Japan), Infinitus (China) Company LTD., Nutrition Development Group, LLC.
Funding
Barilla Center for Food & Nutrition Foundation
Objective: Prior reports using the validated Barriers to Physical Activity in Diabetes (type 1) BAPAD1 scale showed fear of hypoglycemia was the strongest barrier to regular physical activity (PA) in ...people with type 1 diabetes (T1D). This was before the higher prevalence of continuous glucose monitoring (CGM) use today.
Methods: Twenty adults with T1D enrolling in an exercise tracking study completed the BAPAD1, reporting perceived barriers to regular PA on a scale of 1 (extremely unlikely) to 7 (extremely likely). All used insulin pumps. Fifteen of the 20 were current CGM users.
Results: Baseline characteristics were age 44.9±15.0 years, F/M 12/8, HbA1c 6.8±0.7%, and diabetes duration 22.9±15.9 years. Mean BAPAD1 score was 2.55±1.05. The highest scores were for risk of hypoglycemia (4.00±1.78) and work schedule (3.70±2.00), with current CGM users reporting higher overall scores than non-CGM users (2.71±1.04 vs. 2.10±1.07, p=0.28). Significantly higher scores were reported by CGM users for “The fear of being tired” (p=0.01), “The fact that you have diabetes” (p=0.03), and “The location of a gym” (p=0.04) (Table 1). Greater barrier scores for work schedule were associated with lower age (r=-0.5, p=0.02).
Conclusions: CGM use was not associated with lower perceived barriers to regular PA, suggesting additional interventions beyond providing ways to measure glucose are needed to reduce these barriers in people with T1D.
Disclosure
C.C. Andre: None. Y.C. Kudva: Advisory Panel; Self; Novo Nordisk Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. V. Dadlani: None. M. Cescon: None. S.K. McCrady-Spitzer: None. M. Church: None. C. Reid: None. K. Kumari: None. D. Choudhary: None. F.J. Doyle: Consultant; Self; ModeAGC. Other Relationship; Self; Insulet Corporation. E. Dassau: Consultant; Self; Eli Lilly and Company, Insulet Corporation. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Ltd., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; Roche Diabetes Care. Other Relationship; Self; ModAGC. J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Tandem Diabetes Care.
Funding
JDRF; The Leona M. and Harry B. Helmsley Charitable Trust (2-SRA-2017-503-M-B); Dexcom, Inc. (IIS-2017-043)
The target time in range (TIR) for pregnant women with type 1 diabetes (T1D) by the International Consensus on TIR is 70% between 63-140 mg/dL. This is difficult to achieve and is rarely met in the ...literature. Insulin use increases during pregnancy, but prospective data and guidance on pump setting adjustments are limited. Insulin pump delivery and CGM data for 17 T1D women from 3 U.S. sites were prospectively collected every 2 weeks as part of the LOIS-P trial. Subjects enrolled before 17 weeks gestational age (GA) and wore personal pumps and study Dexcom G6 CGM. Changes in mean daily total, basal and bolus doses per kilogram, and TIR for every 2 weeks GA are reported, and linear mixed effects regression models are used for evaluation across trimesters. Enrollment HbA1C was 6.4±0.8%. Total daily dose increased from 0.68 to 0.73 to 0.98 U/kg during the first, second and third trimesters, respectively (p<0.01). Basal dose increased from 0.31 to 0.36 to 0.44 (p<0.01). Bolus dose increased from 0.37 to 0.37 to 0.54 (p<0.01). Daily TIR was 68%, 60% and 63% (p=0.9), with 29% of subjects achieving >70% TIR during pregnancy. Time below target was 5%, 4% and 2%. Doses trended upwards around 24 weeks GA. Postpartum doses decreased significantly. While insulin doses were increased significantly across pregnancy, most subjects did not achieve > 70% TIR. Systems that are customized to this population’s targets with changing insulin sensitivity are needed.
Disclosure
G. O’Malley: Research Support; Self; Abbott, Dexcom, Inc. B. Ozaslan: None. C. Levister: None. M. Trinidad: None. K.N. Castorino: Research Support; Self; Abbott, Dexcom, Inc., Medtronic, Mylan, Novo Nordisk Inc. D. Desjardins: None. M. Church: None. B.H. Smith: None. S.J. Ogyaadu: None. M. Piper: None. C. Reid: None. S.K. McCrady-Spitzer: None. R. Kaur: None. W.K. Kremers: Research Support; Self; AstraZeneca. F.J. Doyle: Research Support; Self; DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Mode AGC. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. J.E. Pinsker: Advisory Panel; Self; Medtronic. Consultant; Self; Eli Lilly and Company, Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Tandem Diabetes Care. Speaker’s Bureau; Self; Tandem Diabetes Care. C.J. Levy: Consultant; Self; Dexcom, Inc. Employee; Spouse/Partner; Allergan plc. Research Support; Self; Abbott, Dexcom, Inc., Insulet Corporation. B. Rosenn: None. Y.C. Kudva: Research Support; Self; Dexcom, Inc., Roche Diabetes Care. Other Relationship; Self; Abbott. E. Dassau: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; Roche Diabetes Care. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care.
Funding
National Institutes of Health (R01DK120358); Dexcom, Inc. (AP-2018-016)
PDF
