To evaluate the effect of hybrid-closed loop Control-IQ technology (Control-IQ) in randomized controlled trials (RCTs) in subgroups based on baseline characteristics such as race/ethnicity, ...socioeconomic status (SES), prestudy insulin delivery modality (pump or multiple daily injections), and baseline glycemic control.
Data were pooled and analyzed from 3 RCTs comparing Control-IQ to a Control group using continuous glucose monitoring in 369 participants with type 1 diabetes (T1D) from age 2 to 72 years old.
Time in range 70-180 mg/dL (TIR) in the Control-IQ group (
= 256) increased from 57% ± 17% at baseline to 70% ± 11% during follow-up, and in the Control group (
= 113) was 56% ± 15% and 57% ± 14%, respectively (adjusted treatment group difference = 11.5%, 95% confidence interval +9.7% to +13.2%,
< 0.001), an increase of 2.8 h/day on average. Significant reductions in mean glucose, hyperglycemia metrics, hypoglycemic metrics, and HbA1c were also observed. A statistically similar beneficial treatment effect on time in range 70-180 mg/dL was observed across the full age range irrespective of race-ethnicity, household income, prestudy continuous glucose monitor use, or prestudy insulin delivery method. Participants with the highest baseline HbA1c levels showed the greatest improvements in TIR and HbA1c.
This pooled analysis of Control-IQ RCTs demonstrates the beneficial effect of Control-IQ in T1D across a broad spectrum of participant characteristics, including racial-ethnic minority, lower SES, lack of prestudy insulin pump experience, and high HbA1c levels. The greatest benefit was observed in participants with the worst baseline glycemic control in whom the auto-bolus feature of the Control-IQ algorithm appears to have substantial impact. Since no subgroups were identified that did not benefit from Control-IQ, hybrid-closed loop technology should be strongly considered for all youth and adults with T1D. Clinical Trials Registry: clinicaltrials.gov; NCT03563313, NCT03844789, and NCT04796779.
Cardiovascular disease (CVD) remains the leading cause of death in people with diabetes, and the risk of CVD for adults with diabetes is at least two to four times the risk in adults without ...diabetes. Complications of diabetes, including not only CVD but also microvascular diseases such as retinopathy and nephropathy, are a major health and financial burden. Diabetes is a disease of glucose intolerance, and so much of the research on complications has focused on the role of hyperglycemia. Clinical trials have clearly demonstrated the role of hyperglycemia in microvascular complications of diabetes, but there appears to be less evidence for as strong of a relationship between hyperglycemia and CVD in people with diabetes. Hypoglycemia has become a more pressing health concern as intensive glycemic control has become the standard of care in diabetes. Clinical trials of intensive glucose lowering in both type 1 and type 2 diabetes populations has resulted in significantly increased hypoglycemia, with no decrease in CVD during the trial period, although several studies have shown a reduction in CVD with extended follow-up. There is evidence that hypoglycemia may adversely affect cardiovascular risk in patients with diabetes, and this is one potential explanation for the lack of CVD prevention in trials of intensive glycemic control. Hypoglycemia causes a cascade of physiologic effects and may induce oxidative stress and cardiac arrhythmias, contribute to sudden cardiac death, and cause ischemic cerebral damage, presenting several potential mechanisms through which acute and chronic episodes of hypoglycemia may increase CVD risk. In this review, we examine the risk factors and prevalence of hypoglycemia in diabetes, review the evidence for an association of both acute and chronic hypoglycemia with CVD in adults with diabetes, and discuss potential mechanisms through which hypoglycemia may adversely affect cardiovascular risk.
The future of telehealth in type 1 diabetes Cobry, Erin C; Wadwa, R Paul
Current opinion in endocrinology, diabetes, and obesity,
08/2022, Letnik:
29, Številka:
4
Journal Article
Recenzirano
Although telemedicine and telehealth services have been a part of type 1 diabetes (T1D) clinical care for several decades, the expansion of in-home telemedicine during the COVID-19 pandemic ...significantly increased interest in long-term use as part of routine care. This review highlights the current literature regarding telemedicine in T1D care as well as the benefits and barriers to use in a postpandemic world.
Telemedicine has increased patient contact with healthcare providers, allowing for more frequent insulin dose adjustments and improvements in glycemic outcomes. In addition to routine clinical care, T1D device training and mental healthcare have been successful through telemedicine. Significant barriers to continued telemedicine care exist, including patient access and technology knowledge, language, and loss of face-to-face interaction. Healthcare providers additionally face unpredictable reimbursement and loss of continuity across state lines, and lack of resources and training for device downloads and telemedicine software.
Telemedicine can be successfully used in T1D care and has the potential to significantly impact glycemic and long-term outcomes. Due to continued interest for in-person visits by people with T1D and providers, it is likely that long-term telemedicine use will include a hybrid format.
Examine patient-reported outcomes (PROs) after the use of t:slim X2 insulin pump with Control-IQ technology (CIQ) in young children with type 1 diabetes.
Children with type 1 diabetes, ages 2 ...to < 6 years (n = 102), were randomly assigned 2:1 to either CIQ or standard care (SC) with pump or multiple daily injections (MDI) plus continuous glucose monitoring (CGM) for 13 weeks. Both groups were offered to use CIQ for an additional 13 weeks after the randomized control trial’s (RCT) completion. Guardians completed PRO questionnaires at baseline, 13-, and 26-weeks examining hypoglycemia concerns, quality of life, parenting stress, and sleep. At 26 weeks, 28 families participated in user-experience interviews. Repeated measures analyses compared PRO scores between systems used.
Comparing CIQ vs SC, responses on all 5 PRO surveys favored the CIQ group, showing that CIQ was superior to SC at 26 weeks (p values < 0.05). User-experience interviews indicated significant benefits in optimized glycemic control overall and nighttime control (28 of 28 families endorsed). All but 2/28 families noted substantial reduction in management burden resulting in less mental burden and all but 4 stated that they wanted their children to continue using CIQ.
Families utilizing CIQ experienced glycemic benefits coupled with substantial benefits in PROs, documented in surveys and interviews. Families utilizing CIQ had reduced hypoglycemia concerns and parenting stress, and improved quality of life and sleep. These findings demonstrate the benefit of CIQ in young children with type 1 diabetes that goes beyond documented glycemic benefit.
The American Diabetes Association (ADA) recommends that children with type 1 diabetes (T1D) see a multidisciplinary team and have hemoglobin A1c (A1C) levels measured every 3 months. Patients in ...rural areas may not follow guidelines because of limited specialty care access. We hypothesized that videoconferencing would result in equivalent A1C compared with in-person visits and increased compliance with ADA recommendations.
The Barbara Davis Center (BDC) (Aurora, CO) telemedicine program provides diabetes care to pediatric patients in Casper and Cheyenne, WY, via remote consultation with annual in-person visits. Over 27 months, 70 patients were consented, and 54 patients completed 1 year in the study.
Patients were 70% male, with a mean age of 12.1 ± 4.1 years and T1D duration of 5.4 ± 4.1 years. There was no significant change between baseline and 1-year A1C levels for patients with data at both time points. Patients saw diabetes specialists an average of 2.0 ± 1.3 times per year in the year prior to starting telemedicine and 2.9 ± 1.3 times (P < 0.0001) in the year after starting telemedicine. Patients and families missed significantly less school and work time to attend appointments.
Our study suggests telemedicine is equivalent to in-person visits to maintain A1C, whereas families increase the number of visits in line with ADA recommendations. Patients and families miss less school and work. Decreased financial burden and increased access may improve overall diabetes care and compliance for rural patients. Further study is needed to detect long-term differences in complications screenings and the financial impact of telemedicine on pediatric diabetes care.
Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and ...prolonged exercise in adolescents and children. We present the performance of the Tandem Control-IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control.
In a randomized controlled trial, 24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff.
The Control-IQ system improved percent time within range (70-180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events.
The use of the Control-IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM-SAP in pediatric patients with T1D during prolonged intensive winter sport activities.
Assess the efficacy of inControl AP, a mobile closed-loop control (CLC) system.
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 HbA
<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.
Between November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (
= 65) versus SAP (
= 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;
< 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;
< 0.0001 for noninferiority). One severe hypoglycemic event occurred in the CLC group, which was unrelated to the study device.
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.
The objective of this study was to assess the safety and performance of the Omnipod
personalized model predictive control (MPC) algorithm with variable glucose setpoints and moderate intensity ...exercise using an investigational device in adults with type 1 diabetes (T1D).
A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient standard treatment phase. Adults aged 18-65 years with T1D and HbA1c between 6.0% and 10.0% were eligible. Subjects completed two moderate intensity exercise sessions of >30 min duration on consecutive days: the first with the glucose set point increased from 130 to 150 mg/dL and the second with a temporary basal rate of 50%, both started 90 min pre-exercise. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL.
Twelve subjects participated in the study, with (mean ± standard deviation) age 36.5 ± 14.4 years, diabetes duration 21.7 ± 15.7 years, HbA1c 7.6% ± 1.1%, and total daily dose 0.60 ± 0.22 U/kg. Outcomes for the 54-h HCL period were mean glucose: 136 ± 14 mg/dL, percentage time <70 mg/dL: 1.4% ± 1.3%, 70-180 mg/dL: 85.1% ± 9.3%, and ≥250 mg/dL: 1.8% ± 2.4%. In the 12-h period after exercise start, percentage time <70 mg/dL was 1.4% ± 2.7% with the raised glucose set point and 1.6% ± 3.0% with reduced basal rate. The percentage time <70 mg/dL overnight was 0% ± 0% on both study nights.
The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to variable glucose set points and with temporarily raised glucose set point or reduced basal rate 90 min in advance of moderate intensity exercise in adults with T1D.
Youth with T1D and their parents are susceptible to diabetes-related nocturnal awakenings, which have been associated with reduced sleep duration and quality. We conducted an observational study of ...youth with T1D starting on the Tandem Control-IQ (CIQ) hybrid closed-loop (HCL) system to evaluate the impact of system use on sleep.
Thirty-nine youth (age 11.1±3.6 yrs, T1D duration 2.5±3.0 yrs, 54% male) and a parent (age 42.5±6.7 yrs, 18% male) completed sleep diaries capturing the number of and reasons for nocturnal awakenings over a 7-day period. Analyses compared diaries from before starting CIQ (baseline) to 3- and 6-months after starting CIQ using a zero-inflated Poisson mixed model with random intercept for participants.
Youth and parents reported significantly fewer total awakenings per night at 3- and 6-months compared to baseline (Table) . A significant decrease in diabetes-related awakenings was observed after 6 months in youth but not in parents.
Following CIQ initiation, fewer nocturnal awakenings were reported by parents and youth, with youth additionally reporting significantly fewer diabetes-related awakenings at 6 months. Due to the subjective nature of diaries, the number of true awakenings may be different. The results suggest that HCL technology may be beneficial in reducing sleep disruptions in youth and parents.
Disclosure
A.J.Karami: None. L.Pyle: None. T.B.Vigers: None. E.Jost: Other Relationship; Tandem Diabetes Care, Inc. R.Wadwa: Advisory Panel; Dompé, Consultant; Beta Bionics, Inc., Other Relationship; Tandem Diabetes Care, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. E.C.Cobry: None.
PDF
