User Experiences of a Bihormonal Fully Closed-Loop System Among Adults with Type 1 Diabetes in a Real-World Setting: A Qualitative Analysis.

Closing the loop

Purpose of ReviewThis manuscript describes how person-reported outcomes (PROs) can be utilized in care for young people with diabetes in the context of motivation.Recent FindingsThe use of person-reported outcome measures (PROMS) in clinical care is feasible and acceptable, and helps focus the clinical encounter on life domains important to the person with diabetes. Results with regard to impact on self-management and glycemic outcomes are limited. Motivation is an important factor for self-management. Based on self-determination theory, autonomy-supportive, person-centered, and collaborative communication by diabetes care providers is associated with better outcomes. PROMs can facilitate this conversation.SummaryUnderstanding of youth motivation for maintaining or improving self-management behaviors requires a person-centered approach. PROMs can be used to facilitate an autonomy-supportive and person-centered conversation in clinical care. Training diabetes care providers in autonomy-supportive, person-centered conversation skills to discuss PROs might help to tap into youth’s motivation, but further research is needed.

Many adolescents with type 1 diabetes experience diabetes distress which is associated with suboptimal glycemic and psychosocial outcomes. The ways in which adolescents respond to diabetes distress may serve as a risk or protective factor for these outcomes, but few studies have examined the coping strategies adolescents use to manage diabetes distress. To examine the association of coping strategies with glycemic and psychosocial outcomes among adolescents experiencing diabetes distress. Participants included 198 adolescents with elevated diabetes distress who completed baseline data for a randomized controlled trial (Mage = 15.3 ± 1.4, 58% female, 58% non-Hispanic White, MA1c = 9.1 ± 2.1%). Adolescents reported on their use of coping strategies related to diabetes stressors, including primary control engagement coping (e.g., problem-solving), secondary control engagement coping (e.g., positive thinking), and disengagement coping (e.g., avoidance). Adolescents also completed measures of diabetes distress, quality of life, and resilience. HbA1c data were extracted from electronic medical records and at-home kits. Higher use of primary control engagement coping was associated with better glycemic and psychosocial outcomes. Secondary control engagement coping was associated with better psychosocial outcomes but not glycemic outcomes. Greater use of disengagement coping strategies was associated with poorer glycemic and psychosocial outcomes. All associations were significant after adjusting for adolescent sex, age, race/ethnicity, and continuous glucose monitor use. These results build on prior findings by including a more diverse sample of adolescents and highlight the value of promoting engagement coping strategies and discouraging the use of disengagement coping strategies among adolescents experiencing diabetes distress. NCT03845465.

In Brief Objective To identify factors associated with long-term hormone replacement therapy (HRT) and reasons for early discontinuation of it. Methods A cross-sectional study was conducted in four United Kingdom group general practices. Six hundred fifteen past or present HRT users (representing a response rate of 66%) responded to questionnaires on HRT and potential determinants of long-term use. Main outcome measures were long-term HRT use (at least 6 years) as opposed to short-term use (at most 2 years) and self-reported reasons for discontinuation. Odds ratios (ORs) of long-term use were adjusted for age and other variables, in the same groups, calculated by logistic regression and 95% confidence intervals (CIs). Results Ovariectomy (OR 2.59, 95% CI 1.12, 5.97), hysterectomy (OR 2.28, 95% CI 1.37, 3.79), previous oral contraceptive use (OR 1.76, 95% CI 1.03, 3.01), HRT prescription to prevent osteoporosis (OR 1.81, 95% CI 1.04, 3.13), opinion that HRT prevents health problems (OR 3.22, 95% CI 1.57, 6.63), opinion that HRT is associated with health risks (OR 0.23, 95% CI 0.08, 0.65), and opinion that HRT has cosmetic benefits (OR 2.52, 95% CI 1.45, 4.40) were statistically significantly associated with long-term HRT. Women surveyed most often reported side effects and weight gain (each about 30%) as reasons for discontinuation, followed by possible health risks and dislike of menstrual bleeding or hormones (each about 15%). Conclusion Ovariectomy, hysterectomy, and opinions about benefits and disadvantages of HRT were the most important determinants of long-term use, whereas women themselves mentioned side effects and weight gain most frequently as reasons for discontinuing it. Ovariectomy, hysterectomy, prescription for prevention purposes, previous oral contraceptive use, and opinions regarding hormone replacement therapy lead to its long-term use.

Objective: To investigate the safety and efficacy of the addition of a trust index to enhanced Model Predictive Control (eMPC) Artificial Pancreas (AP) that works by adjusting the aggressiveness of the controller’s insulin delivery based on the confidence intervals around predictions of glucose trends. Methods: After one week of sensor-augmented pump (SAP) use, subjects completed a 48-hour AP admission that included 3 meals/day of at least 30 g CHO per meal, 1 hour of unannounced exercise and two overnight periods. Endpoints included sensor glucose percentage time 70-180 mg/dL, <70 mg/dL, >180 mg/dL, number of hypoglycemic events, and assessment of the trust index vs. standard eMPC glucose predictions. Results: Baseline characteristics for the 15 subjects (mean±SD) were age 46.1±17.8 years, HbA1c 7.2±1.0%, diabetes duration 26.8±17.6 years and TDD 35.5±16.4 units/day. Glycemic outcomes are reported in the table. Mean percent time 70-180 mg/dL (88.0±7.7%), <70 mg/dL (1.5±1.8%), and number of hypoglycemic events (0.6±0.6%) all showed statistically significant improvement during AP (p<0.001). On average, the trust index enhanced controller responsiveness to predicted hyper- and hypoglycemia by 26% (p<0.005). Glycemic Outcomes. eMPC Artificial Pancreas with Trust Index vs. Sensor-Augmented Pump.Glycemic Outcomes (Mean±SD)48-Hour AP SessionSAP Run-In Weekp-valuePercentage Time 70-180, mg/dL88.0±7.774.6±9.0<0.001Percentage Time 80-140, mg/dL60.1±13.445.2±10.30.004Percentage Time < 70, mg/dL1.5±1.87.8±5.8<0.001Percentage Time > 180, mg/dL10.5±7.717.6±10.40.081Mean CGM, mg/dL130.1±14.7135.1±18.8>0.5Standard Deviation, mg/dL32.9±6.150.3±10.5<0.001Number of daily hypoglycemic events (CGM <70 mg/dL for ≥ 15 minutes)0.6±0.61.7±0.9<0.001 Conclusions: eMPC AP with trust index additions achieved nearly 90% time in the target glucose range. Additional studies will further validate these results. Disclosure J.E. Pinsker: Research Support; Self; Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. A.J. Laguna Sanz: None. M. Church: None. J. Lee: Employee; Self; Insulet Corporation. L. Lindsey: None. C.C. Andre: None. F.J. Doyle: Research Support; Self; Insulet Corporation, Roche Diagnostics Corporation, Xeris Pharmaceuticals, Inc., Dexcom, Inc., DreaMed Diabetes, Ltd., LifeScan, Inc.. Other Relationship; Self; ModeAGC. E. Dassau: Consultant; Self; Insulet Corporation. Research Support; Self; Insulet Corporation. Consultant; Self; Animas Corporation. Research Support; Self; Dexcom, Inc.. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions, Xeris Pharmaceuticals, Inc.. Consultant; Self; Eli Lilly and Company. Research Support; Self; Tandem Diabetes Care, Inc.. Other Relationship; Self; ModAGC. Research Support; Self; LifeScan, Inc., DreaMed Diabetes, Ltd..

This multicenter prospective observational cohort study assessed real-world changes in glycemic and person-reported outcomes one-year after Control-IQ initiation in children and adolescents with type 1 diabetes. Between October 2021 and December 2022, all children 6-18 years who started Control-IQ at 13 Belgian centers were consecutively recruited. Data were collected at start of Control-IQ and after 4, 8 and 12 months. Person-reported outcomes were evaluated through questionnaires (Diabetes Quality of Life for Youth [DQOLY], Hypoglycemia Fear Survey [HFS], HAPPI-D). Data are reported as mean ± SD or least-squares mean (95% CI). A total of 114 children were included, with a mean age of 12.0 ± 3.2 years and of whom 61.4% were girls. Time in range (3.9-10.0 mmol/L) increased from start (51.6% [47.6-55.5]) to 12 months (64.4% [61.2-67.5]) (p<0.001). After 12 months, HbA1c decreased from 62 mmol/mol (60-65) (7.8% [7.6-8.1]) to 54 mmol/mol (52-56) (7.1% [6.9-7.3]) and time <3.9 mmol/L from 3.9% (3.1-4.8) to 2.7% (1.9-3.5) (all p<0.001). Children scored better on DQOLY satisfaction (70.4 [67.8-73.0] vs 74.0 points [71.3-76.6]) and DQOLY impact (54.6 [50.9-58.3] vs 51.3 points [47.4-55.1]), and parents on HAPPI-D (22.5 [21.1-23.9] vs 19.6 points [18.2-21.0]) and HFS worry (25.0 [21.6-28.4] vs 20.3 points [17.0-23.5] (all p<0.001). Children missed fewer days of school (287 vs 30 days/100 person-years, p=0.001) and parents missed less days of work (247 vs 47 days/100 person-years, p<0.001). One-year use of Control-IQ was associated with improved glycemic management, more diabetes-related quality of life and fewer school/work absences.

Determinants of long-term hormone replacement therapy and reasons for early discontinuation

Adaptive tuning of basal and bolus insulin to reduce postprandial hypoglycemia in a hybrid artificial pancreas

Extended Characterization of Newly Diagnosed Multiple Myeloma (NDMM) Patients with In-Class Transition (iCT) from Parenteral Bortezomib to Oral Ixazomib Proteasome Inhibitor (PI) Therapy in the Community-Based United States (US) MM-6 Study: Updated Efficacy and Safety, and Reasons for Premature Discontinuation

We evaluated the effect of the MD-Logic system on overnight glycemic control at patients' homes. Twenty-four patients (aged 12-43 years; average A1c 7.5 ± 0.8%, 58.1 ± 8.4 mmol/mol) were randomly assigned to participate in two overnight crossover periods, each including 6 weeks of consecutive nights: one under closed loop and the second under sensor-augmented pump (SAP) therapy at patients' homes in real-life conditions. The primary end point was time spent with sensor glucose levels below 70 mg/dL (3.9 mmol/L) overnight. Closed-loop nights significantly reduced time spent in hypoglycemia (P = 0.02) and increased the percentage of time spent in the target range of 70-140 mg/dL (P = 0.003) compared with nights when the SAP therapy was used. The time spent in substantial hyperglycemia above 240 mg/dL was reduced by a median of 52.2% (interquartile range [IQR] 4.8, 72.9%; P = 0.001) under closed-loop control compared with SAP therapy. Overnight total insulin doses were lower in the closed-loop nights compared with the SAP nights (P = 0.04). The average daytime glucose levels after closed-loop operation were reduced by a median of 10.0 mg/dL (IQR -2.7, 19.2; P = 0.017) while lower total insulin doses were used (P = 0.038). No severe adverse events occurred during closed-loop control; there was a single event of severe hypoglycemia during a control night. The long-term home use of automated overnight insulin delivery by the MD-Logic system was found to be a feasible, safe, and an effective tool to reduce nocturnal hypoglycemia and improve overnight glycemic control in subjects with type 1 diabetes.

There is growing recognition that to maximize service impacts, first-time users of community mental health services require treatment approaches different from those for experienced users. This study examines differences between new and ongoing service users in their sociodemographic and clinical characteristics, how episodes of the treatment status (new vs. ongoing) interact with problem severity and the level of functioning at the baseline and three-month follow-up; and the role of the service quantity, satisfaction, and hopefulness in predicting service outcomes for children. The results of mixed factorial ANOVAs reveal significant interactions between new/ongoing treatment conditions and problem severity as well as functioning across time periods. New users showed higher problem severity at the baseline than at T2 in comparison with ongoing users. In addition, new users showed lower functioning scores at the baseline than at T2 in comparison with ongoing users. Hopefulness predicted problem severity for new and ongoing users, and service satisfaction predicted problem severity only for ongoing users. In terms of functional outcomes, gender, diagnosis, the number of providers, and hopefulness were predictors for new users, and hopefulness was a predictor for ongoing users. The results suggest a need for using different treatment approaches for new versus ongoing users.

Objective: Examine gestational safety, glycemic and health outcomes, of a hybrid closed-loop (HCL) system without pregnancy-specific glucose targets. Research Design: This was a pilot feasibility investigator-initiated, two-site, single-blind, randomized controlled trial of sensor-augmented pump therapy (SAPT) versus HCL therapy in type 1 diabetes pregnancies. Participants were enrolled in the first trimester and randomized at 14-18 weeks of gestation and used SAPT or HCL until 4-6 weeks postpartum. We compared continuous glucose monitoring (CGM) metrics, severe hypoglycemia (SH), diabetic ketoacidosis (DKA), adverse skin reactions, and pregnancy outcomes between groups. Results: Baseline characteristics were similar between groups (n = 11 HCL and n = 12 SAPT). There was no SH or DKA episode after randomization. Time spent <54 mg/dL did not differ between groups. Time spent <63 mg/dL decreased in both groups, significantly in the HCL group (3.5% [1.3% standard error] second trimester and 2.8% [1.3%] third trimester vs. 7.9% [1.3%] run-in phase, P < 0.05 for both). Mean sensor glucose was lower with SAPT compared to HCL therapy in the third trimester (119 [4] mg/dL SAPT vs. 132 [4] mg/dL HCL, P < 0.05). Third trimester time-in-range (TIR; 63-140 mg/dL) increased with SAPT (68.2% [3.1%] vs. 64.3% [3.1%] run-in phase, P < 0.05). Gestational health outcomes did not differ between groups. The HCL group used assistive techniques, such as fake carbohydrate boluses and exiting HCL overnight. Conclusions: CGM within group differences were seen for time <63 mg/dL favoring HCL therapy and TIR favoring SAPT (third trimester vs. baseline). Safety and adverse pregnancy outcomes were similar between groups.

As artificial pancreas (AP) becomes standard of care, consideration of extended use of insulin infusion sets (IIS) and continuous glucose monitors (CGMs) becomes vital. We conducted an outpatient randomized crossover study to test the safety and efficacy of a zone model predictive control (zone-MPC)-based AP system versus sensor augmented pump (SAP) therapy in which IIS and CGM failures were provoked via extended wear to 7 and 21 days, respectively. A smartphone-based AP system was used by 19 adults (median age 23 years [IQR 10], mean 8.0 ± 1.7% HbA1c) over 2 weeks and compared with SAP therapy for 2 weeks in a crossover, unblinded outpatient study with remote monitoring in both study arms. AP improved percent time 70-140 mg/dL (48.1 vs. 39.2%; P = 0.016) and time 70-180 mg/dL (71.6 vs. 65.2%; P = 0.008) and decreased median glucose (141 vs. 153 mg/dL; P = 0.036) and glycemic variability (SD 52 vs. 55 mg/dL; P = 0.044) while decreasing percent time <70 mg/dL (1.3 vs. 2.7%; P = 0.001). AP also improved overnight control, as measured by mean glucose at 0600 h (140 vs. 158 mg/dL; P = 0.02). IIS failures (1.26 ± 1.44 vs. 0.78 ± 0.78 events; P = 0.13) and sensor failures (0.84 ± 0.6 vs. 1.1 ± 0.73 events; P = 0.25) were similar between AP and SAP arms. Higher percent time in closed loop was associated with better glycemic outcomes. Zone-MPC significantly and safely improved glycemic control in a home-use environment despite prolonged CGM and IIS wear. This project represents the first home-use AP study attempting to provoke and detect component failure while successfully maintaining safety and effective glucose control.

This multicentre prospective observational cohort study aimed to evaluate real-world changes in glycaemic and person-reported outcomes after 1 year's use of Control-IQ technology in adults with type 1 diabetes. Adults who started with Control-IQ between December 2021 and December 2022 were consecutively recruited in 13 Belgian diabetes centres. Data were collected at start and after 4, 8 and 12 months. The primary endpoint was the evolution of time in range (TIR; glucose levels of 3.9-10.0 mmol/l). Data are reported as mean ± SD or least-squares mean (95% CI). A total of 473 adults were included, with a mean age of 38.5±13.1 years and of whom 57.3% were female. TIR increased from 58.8% (95% CI56.7, 60.9) at start to 70.9% (69.1, 72.8) at 12 months (p<0.001). HbA1c decreased from 57.3 mmol/mol (56.1, 58.5) (7.4% [7.3, 7.5]) to 49.5 mmol/mol (48.5, 50.6) (6.7% [6.6, 6.8]) and time <3.9 mmol/l from 4.2% (3.9, 4.6) to 1.9% (1.8, 2.1) (all p<0.001). Participants scored better on the Hypoglycaemia Fear Survey version 2 worry (22.5 [21.3, 23.7] vs 18.1 points [17.0, 19.3]), the Problem Areas in Diabetes - Short Form (7.2 [6.7, 7.8] vs 6.1 points [5.5, 6.7]), and the Diabetes Treatment Satisfaction Questionnaire status (25.5 [24.8, 26.2] vs 31.0 points [30.4, 31.6]) (all p<0.001). The number of self-reported severe hypoglycaemia events (37.5 [21.3, 65.9] vs 15.7 [9.7, 25.3] events per 100 person-years, p=0.002) and work absenteeism days (116.3 [42.8, 315.5] vs 69.3 [25.4, 189.2] days per 100 person-years, p=0.034) decreased. One-year use of Control-IQ was associated with better glucose management, improved diabetes-related quality of life, more treatment satisfaction, less severe hypoglycaemia and less work absenteeism in adults with type 1 diabetes. ClinicalTrials.gov NCT04414280.

Living with sensor-augmented pump therapy in type 1 diabetes: adolescents' and parents' search for harmony.