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1.
N Engl J Med ; 387(10): 869-881, 2022 09 08.
Artículo en Inglés | MEDLINE | ID: mdl-36069869

RESUMEN

BACKGROUND: Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system. METHODS: In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial). RESULTS: A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues. CONCLUSIONS: In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).


Asunto(s)
Glucemia , Diabetes Mellitus Tipo 1 , Hipoglucemiantes , Bombas de Infusión , Insulina , Adolescente , Adulto , Anciano , Australia , Glucemia/análisis , Niño , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Humanos , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Persona de Mediana Edad , Adulto Joven
2.
Diabet Med ; 39(5): e14750, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-34826158

RESUMEN

BACKGROUND: Open-source automated insulin delivery (AID) is a user-driven treatment modality used by thousands globally. Healthcare professionals' (HCPs) ability to support users of this technology is limited by a lack of knowledge of these systems. AIMS: To describe the challenges experienced by HCPs supporting participants' use of open-source automated insulin delivery in the Community deRivEd AuTomatEd insulin delivery (CREATE) study. METHODS: Data were collected prospectively from the study team's fortnightly meetings and Slack Workspace (Slack Technologies, Ltd. 2018) during the first 4 months of the trial. Key topics were identified from minutes of meetings. Slack conversations were categorised by topic, with the number of posts per conversation, number of sites per conversation and involvement of experts in open-source AID being recorded. RESULTS: In the first 4 months of the trial, there were 254 conversations in Slack with a mean of 5.2 (±4.25) posts per conversation. The most frequent learning challenge was insulin pump and cannula problems relating to the DANA-iTM insulin pump, which totalled 24.0% of all conversations. Experts on open-source AID use were involved in 83.3% of conversations. CONCLUSIONS: A significant proportion of challenges related to specific devices, rather than AID. Challenges relating to the functioning of open-source AID were more likely to involve input from experts in open-source AID. This is the first report of challenges experienced by a multidisciplinary team in a supported open-source environment that may inform expectations in routine clinical care.


Asunto(s)
Diabetes Mellitus Tipo 1 , Páncreas Artificial , Atención a la Salud , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico
3.
Diabetes Technol Ther ; 26(1): 40-48, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37823890

RESUMEN

Objective: To investigate 12-month glycemic and psychosocial changes following transition from multiple daily injections (MDI) to advanced hybrid closed-loop (AHCL) therapy in youth (aged 13-25 years) with type 1 diabetes and suboptimal glycemia (glycated hemoglobin [HbA1c] ≥8.5% [69 mmol/mol]). Research Design and Methods: Prospective, single arm, dual-center study in 20 participants. Extension phase outcomes reported after 12 months, including HbA1c, time in glycemic ranges, AHCL system performance, and psychosocial questionnaires assessing quality of life, diabetes treatment, and sleep. Results: After 12 months, 19 out of 20 participants continued to use AHCL. Average time-in-range 70-180 mg/dL (3.9-10.0 mmol/L) improved from 27.6% ± 13.2% to 62.5% ± 11.4%. This translated to an average 2.5 percentage-point (27.1 mmol/mol) improvement in HbA1c from 10.5% ± 2.1% (91.2 mmol/mol) at baseline to 8.0% ± 0.9% (64.1 mmol/mol) at 12 months. Psychosocial questionnaires and very high HbA1c at study entry indicated significant diabetes-associated burden for both individuals and parents. After 12 months, improvements were observed in general and diabetes-specific health-related quality of life, as well as in diabetes treatment satisfaction. Safety data were reassuring with a diabetic ketoacidosis rate of 0.15 per participant-year after 12 months of AHCL (compared to 0.25 per participant-year in the 12 months before the study). Conclusions: After 12 months of AHCL usage, this study highlights the potential for substantial and sustained glycemic and psychosocial improvements among individuals experiencing considerable diabetes burden and suboptimal glycemia, following their switch from MDI to AHCL.


Asunto(s)
Diabetes Mellitus Tipo 1 , Humanos , Adolescente , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/psicología , Hipoglucemiantes/uso terapéutico , Glucosa , Insulina/uso terapéutico , Calidad de Vida , Estudios Prospectivos , Resultado del Tratamiento , Sistemas de Infusión de Insulina , Automonitorización de la Glucosa Sanguínea , Glucemia
4.
Front Endocrinol (Lausanne) ; 14: 1214975, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37693343

RESUMEN

Introduction: To evaluate the experiences of patients with type 1 diabetes following transition from a calibration-requiring to a calibration-free sensor and remote monitoring in the context of using automated insulin delivery (AID). Research design and methods: Fifteen participants aged 7-65 years with type 1 diabetes participating in a longitudinal study used a Medtronic® advanced hybrid closed loop (AHCL) device with initially calibration-requiring then calibration-free sensors. Qualitative interviews were conducted ≥20 weeks following use of the calibration-requiring and ≥4 weeks after use of the calibration-free sensors/remote monitoring. Thematic analysis was used to identify key themes and subthemes. Results: At baseline, mean diabetes duration was 14.5 years ( ± 10.9), mean Hba1c 54.8 mmol/mol ( ± 10.2) (7.2 ± 0.9%) and Time in range 75.4% ( ± 11.6). Participants reported a progressive improvement in digital and lifestyle integration, and device trust following transition to calibration-free sensors with remote monitoring potential. They also reported a reduced need for capillary glucose, increased device satisfaction and trust, and reduced burden of diabetes care. Negative aspects reported included periodic early sensor loss, and for some, impaired integration with mobile devices. Conclusion: Transitioning to calibration-free sensors with remote monitoring while using AHCL was associated with better user experience, including perceptions of improved quality of life and a reduced burden of diabetes care. Appropriate expectation setting, training, and ongoing support allow for the optimal user experience while using AHCL. Clinical trial registration: https://www.anzctr.org.au, identifier ACTRN12621000360819.


Asunto(s)
Diabetes Mellitus Tipo 1 , Insulina , Humanos , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Estudios Longitudinales , Investigación Cualitativa , Calidad de Vida , Niño , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano
5.
Diabetes Care ; 46(3): 628-632, 2023 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-36689621

RESUMEN

OBJECTIVE: To evaluate glycemic outcomes in youth (aged 13-25 years) with type 1 diabetes and high-risk glycemic control (HbA1c ≥8.5% [69 mmol/mol]) on multiple daily injection (MDI) therapy after transitioning to advanced hybrid closed loop (AHCL) therapy. RESEARCH DESIGN AND METHODS: This prospective, 3-month, single-arm, dual-center study enrolled 20 participants, and all completed the study. RESULTS: HbA1c decreased from 10.5 ± 2.1% (91.2 ± 22.8 mmol/mol) at baseline to 7.6 ± 1.1% (59.7 ± 11.9 mmol/mol), and time spent in target range 70-180 mg/dL (3.9-10.0 mmol/L) increased from 27.6 ± 13.2% at baseline to 66.5 ± 9.8% after 3 months of AHCL. Two episodes of diabetic ketoacidosis attributed to infusion set failure occurred. CONCLUSIONS: AHCL has the potential to improve suboptimal glycemia in youth with type 1 diabetes previously on MDI therapy.


Asunto(s)
Diabetes Mellitus Tipo 1 , Adolescente , Humanos , Glucemia , Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hemoglobina Glucada , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Sistemas de Infusión de Insulina , Estudios Prospectivos , Adulto Joven , Adulto
6.
J Diabetes Metab Disord ; 22(1): 861-871, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37250371

RESUMEN

Purpose: Open-source automated insulin delivery (AID) is used by thousands of people with type 1 diabetes (T1D), but has unknown generalisability to marginalised ethnic groups. This study explored experiences of Indigenous Maori participants in the CREATE trial with use of an open-source AID system to identify enablers/barriers to health equity. Methods: The CREATE randomised trial compared open-source AID (OpenAPS algorithm on an Android phone with a Bluetooth-connected pump) to sensor-augmented pump therapy. Kaupapa Maori Research methodology was used in this sub-study. Ten semi-structured interviews with Maori participants (5 children, 5 adults) and whanau (extended family) were completed. Interviews were recorded and transcribed, and data were analysed thematically. NVivo was used for descriptive and pattern coding. Results: Enablers/barriers to equity aligned with four themes: access (to diabetes technologies), training/support, operation (of open-source AID), and outcomes. Participants described a sense of empowerment, and improved quality of life, wellbeing, and glycaemia. Parents felt reassured by the system's ability to control glucose, and children were granted greater independence. Participants were able to use the open-source AID system with ease to suit whanau needs, and technical problems were manageable with healthcare professional support. All participants identified structures in the health system precluding equitable utilisation of diabetes technologies for Maori. Conclusion: Maori experienced open-source AID positively, and aspired to use this therapy; however, structural and socio-economic barriers to equity were identified. This research proposes strength-based solutions which should be considered in the redesign of diabetes services to improve health outcomes for Maori with T1D.Trial Registration: The CREATE trial, encompassing this qualitative sub-study, was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000034932p) on the 20th January 2020. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01215-3.

7.
Diabetes Technol Ther ; 25(4): 250-259, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36763345

RESUMEN

Aim: To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Methods: Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID). Most participants (69/94) used a preproduction YpsoPump® insulin pump during the continuation phase. Analyses incorporated all 52 weeks of data, and combined between-group and within-subject differences to calculate an overall "treatment effect" of AID versus SAPT. Results: Mean time in range (TIR; 3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT (95% confidence interval [CI] 10.4 to 14.1; P < 0.001). TIR was 56.9% (95% CI 54.2 to 59.6) with SAPT and 69.1% (95% CI 67.1 to 71.1) with AID. The treatment effect did not differ by age (P = 0.39) or insulin pump type (P = 0.37). HbA1c was 5.1 mmol/mol lower [0.5%] with AID (95% CI -6.6 to -3.6; P < 0.001). There were no episodes of diabetic ketoacidosis or severe hypoglycemia with either treatment over the 48 weeks. Six participants (all in SAPT-AID) withdrew: three with hardware issues, two preferred SAPT, and one with infusion-site skin irritation. Conclusion: Further evaluation of the community derived automated insulin delivery (CREATE) trial to 48 weeks confirms that open-source AID is efficacious and safe with different insulin pumps, and demonstrates sustained glycemic improvements without additional safety concerns.


Asunto(s)
Diabetes Mellitus Tipo 1 , Hipoglucemia , Adulto , Humanos , Niño , Insulina/uso terapéutico , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Hipoglucemia/inducido químicamente , Glucemia , Insulina Regular Humana/uso terapéutico , Sistemas de Infusión de Insulina
8.
Acta Diabetol ; 59(1): 31-37, 2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-34453208

RESUMEN

BACKGROUND: Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes. METHODS: We present sub-study data from a dual-center, randomized, open-label, two-sequence crossover study in automated insulin delivery naïve users, comparing Medtronic MiniMed® Advanced Hybrid Closed-Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP + PLGM). At the end of each 4-week intervention, impacts on quality of life, sleep and treatment satisfaction were compared using seven age-appropriate validated questionnaires given to patients or caregivers. RESULTS: 59/60 people completed the study (mean age 23.3 ± 14.4yrs). Statistically significant differences favoring AHCL were demonstrated in several scales (data shown as mean ± SE). In adults (≥ 18yrs), technology satisfaction favored AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (n = 28) vs SAP + PLGM (n = 29) (30.9 ± 0.7 vs 27.9 ± 0.7, p = 0.004) and DTSQc AHCL (n = 29) vs SAP + PLGM (n = 30) (11.7 ± 0.9 vs 9.2 ± 0.8, p = 0.032). Adolescents (aged 13-17yrs) also showed a higher DTSQc score during AHCL (n = 16) versus SAP + PLGM (n = 15) (14.8 ± 0.7 vs 12.1 ± 0.8, p = 0.024). The DTQ "change" score (n = 59) favored AHCL over SAP + PLGM (3.5 ± 0.0 vs 3.3 ± 0.0, p < 0.001). PSQI was completed in those > 16 years (n = 36) and demonstrated improved sleep quality during AHCL vs SAP + PLGM (4.8 ± 0.3 vs 5.7 ± 0.3, p = 0.048) with a total score > 5 indicating poor quality sleep. CONCLUSION: These data suggest that AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.


Asunto(s)
Diabetes Mellitus Tipo 1 , Adolescente , Adulto , Glucemia , Automonitorización de la Glucosa Sanguínea , Niño , Estudios Cruzados , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Sistemas de Infusión de Insulina , Satisfacción Personal , Calidad de Vida , Calidad del Sueño , Tecnología , Adulto Joven
9.
J Diabetes Metab Disord ; 20(2): 2103-2113, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34900846

RESUMEN

PURPOSE: Type 1 diabetes (T1D) management requires regular monitoring of glucose levels and judicious therapeutic administration of insulin to prevent both microvascular and macrovascular complications. Few people with diabetes are able to sustain the self-monitored blood glucose measurements needed for optimal care, and those that do, typically experience significant diabetes-related distress. Both intermittently scanned continuous glucose monitoring (isCGM) and continuous glucose monitoring (CGM) offer alternatives to reduce the overall burden, but both still have limitations. Given the expense of CGM, smart watch integrated do-it-yourself (DIY)-CGM has been developed as an alternative to commercial isCGM and CGM technologies. This study has been designed to evaluate the clinical efficacy of smart watch integrated DIY-CGM compared with isCGM in adults with T1D. METHODS: This multicentre, randomised, crossover study will be conducted in New Zealand and aims to recruit 60 adults with established T1D who currently use isCGM. DIY-CGM will be compared to usual care with isCGM. Participants will be randomised to either arm of the study for 8 weeks followed by a 4-week washout period before crossing over to the other study arm for a further 8 weeks. The primary endpoint is glucose time in range (TIR) defined as percentage of time interstitial glucose is spent between 3.9 to 10 mmol/L for the entire intervention period. Secondary endpoints include diabetes-related quality of life, distress, and sleep quality in participants and their partners. DISCUSSION: The results of this study will provide clinical trial data regarding smart watch integrated DIY-CGM versus isCGM for improving glycaemic control in adults with T1D, and also report a variety of key secondary outcomes, including changes in subjective outcome measures for both people with diabetes and their partners. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12621000648820,31 May 2021); World Health Organisation International Clinical Trial Registry Platform (U1111-1262-2784, 3rd December 2020).

10.
Diabetes Care ; 44(4): 969-975, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-33579715

RESUMEN

OBJECTIVE: To study the MiniMed Advanced Hybrid Closed-Loop (AHCL) system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability. RESEARCH DESIGN AND METHODS: This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-delivery-naive participants with type 1 diabetes (aged 7-80 years) compared AHCL to sensor-augmented pump therapy with predictive low glucose management (SAP + PLGM). Each study phase was 4 weeks, preceded by a 2- to 4-week run-in and separated by a 2-week washout. RESULTS: The study was completed by 59 of 60 people (mean age 23.3 ± 14.4 years). Time in target range (TIR) 3.9-10 mmol/L (70-180 mg/dL) favored AHCL over SAP + PLGM (70.4 ± 8.1% vs. 57.9 ± 11.7%) by 12.5 ± 8.5% (P < 0.001), with greater improvement overnight (18.8 ± 12.9%, P < 0.001). All age-groups (children [7-13 years], adolescents [14-21 years], and adults [>22 years]) demonstrated improvement, with adolescents showing the largest improvement (14.4 ± 8.4%). Mean sensor glucose (SG) at run-in was 9.3 ± 0.9 mmol/L (167 ± 16.2 mg/dL) and improved with AHCL (8.5 ± 0.7 mmol/L [153 ± 12.6 mg/dL], P < 0.001), but deteriorated during PLGM (9.5 ± 1.1 mmol/L [17 ± 19.8 mg/dL], P < 0.001). TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared with 6.7 mmol/L (120 mg/dL), 72.0 ± 7.9% vs. 64.6 ± 6.9%, respectively, with no additional hypoglycemia. Auto Mode was active 96.4 ± 4.0% of the time. The percentage of hypoglycemia at baseline (<3.9 mmol/L [70 mg/dL] and ≤3.0 mmol/L [54 mg/dL]) was 3.1 ± 2.1% and 0.5 ± 0.6%, respectively. During AHCL, the percentage time at <3.9 mmol/L (70 mg/dL) improved to 2.1 ± 1.4% (P = 0.034) and was statistically but not clinically reduced for ≤3.0 mmol/L (54 mg/dL) (0.5 ± 0.5%; P = 0.025). There was one episode of mild diabetic ketoacidosis attributed to an infusion set failure in combination with an intercurrent illness, which occurred during the SAP + PLGM arm. CONCLUSIONS: AHCL with automated correction bolus demonstrated significant improvement in glucose control compared with SAP + PLGM. A lower algorithm SG set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.


Asunto(s)
Diabetes Mellitus Tipo 1 , Adolescente , Adulto , Glucemia , Niño , Estudios Cruzados , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Glucosa/uso terapéutico , Humanos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Sistemas de Infusión de Insulina , Adulto Joven
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