scholarly journals Hybrid Closed-Loop System Achieves Optimal Perioperative Glycemia in a Boy With Type 1 Diabetes: A Case Report

2021 ◽  
Vol 9 ◽  
Author(s):  
Jesus Dominguez-Riscart ◽  
Nuria Buero-Fernandez ◽  
Ana Garcia-Zarzuela ◽  
Fernando A. Marmolejo-Franco ◽  
Ana C. Perez-Guerrero ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Insulin Infusion ◽  
Closed Loop ◽  
Total Duration ◽  
Blood Glucose Monitoring ◽  
Medical Team ◽  
The Family ◽  
The Impact

The goal in type 1 diabetes (T1D) therapy is to maintain optimal glycemic control under any circumstance. Diabetes technology is in continuous development to achieve this goal. The most advanced Food and Drug Administration- and European Medicines Agency-approved devices are hybrid closed-loop (HCL) systems, which deliver insulin subcutaneously in response to glucose levels according to an automated algorithm. T1D is frequently encountered in the perioperative period. The latest international guidelines for the management of children with diabetes undergoing surgery include specific adjustments to the patient's insulin therapy, hourly blood glucose monitoring, and intravenous (IV) insulin infusion. However, these guidelines were published while the HCL systems were still marginal. We present a case of a 9-year-old boy with long-standing T1D, under HCL system therapy for the last 9 months, and needing surgery for an appendectomy. We agreed with the family, the surgical team, and the anesthesiologists to continue HCL insulin infusion, without further adjustments, hourly blood glucose checks or IV insulin, while monitoring closely. The HCL system was able to keep glycemia within range for the total duration of the overnight fast, the surgery, and the initial recovery, without any external intervention or correction bolus. This is, to the best of our knowledge, the first reported pediatric case to undergo major surgery using a HCL system, and the results were absolutely satisfactory for the patient, his family, and the medical team. We believe that technology is ripe enough to advocate for a “take your pump to surgery” message, minimizing the impact and our interventions. The medical team may discuss this possibility with the family and patients.

scholarly journals Hybrid Closed-Loop Insulin Delivery Systems for People With Type 1 Diabetes

2021 ◽  
Vol 1 (3) ◽  
Author(s):  
CADTH Health Technology Assessment Service
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Closed Loop ◽  
Insulin Pump ◽  
Insulin Delivery ◽  
Blood Glucose Monitoring ◽  
Self Management ◽  
Publicly Funded ◽  
Delivery Methods

Blood glucose monitoring and insulin delivery are essential parts of the management of type 1 diabetes. Hybrid closed-loop insulin delivery (HCL) systems are a treatment option for people with type 1 diabetes and consist of an insulin pump, a continuous glucose monitor (CGM), and a computer program (algorithm) that allows the devices to communicate with each other and calculates insulin needs. CADTH conducted a Health Technology Assessment (HTA) of the use of HCL systems compared to other insulin delivery methods in people with type 1 diabetes to inform decisions regarding whether HCL systems have a place in the management of type 1 diabetes. HCL therapy generally improved the amount of time a person spent in target blood glucose ranges. Additionally, people who used HCL systems had improved average blood glucose levels (glycated hemoglobin [A1C]) over the preceding 2 or 3 months. However, the effectiveness or safety of HCL systems based on age, sex, race, glucose management, or other clinical features (e.g., those who are pregnant or planning pregnancy, or who have hypoglycemia unawareness or a history of severe hypoglycemia) is unknown. HCL systems were generally as safe as other insulin delivery methods. Additional studies with longer follow-up periods and more participants are needed to confirm the clinical effectiveness and safety of HCL systems. From a pan-Canadian, publicly funded health care system perspective, the cost of covering HCL systems for individuals with type 1 diabetes who are eligible for insulin pumps in their jurisdictions was estimated to be an additional $822,635,045 over 3 years compared with diabetes supplies that are currently covered. If HCL systems are covered for all individuals with type 1 diabetes, regardless of their current insulin-pump eligibility, the budget impact will be higher. HCL systems can help provide distance from demanding self-management and monitoring tasks for people living with type 1 diabetes; however, in order to do this, people using these systems must navigate complex relationships built on trust and collaboration. Given that type 1 diabetes self-management to date has required considerable attention to blood glucose numbers and technical tasks, developing these relationships of trust and collaboration will require a shift in understanding what it means to care for someone who has — or to self-manage — type 1 diabetes. It is not possible to conclude whether HCL systems will improve overall population health over the longer-term because the data for this are not available. It is also unclear which people with type 1 diabetes would benefit most from HCL systems. Eligibility criteria for the existing public insulin-pump program may be useful in making coverage decisions; trial periods may be considered to ensure HCL systems are working well for new users. Education and support are needed for people living with type 1 diabetes when they start to use HCL systems. Clinicians noted the need for interactions between diabetes educators and HCL system pump users. User-friendly devices and understandable reports are key to effective use. Eligibility for access through any publicly funded program for HCL systems should be based on evidence. The criteria for coverage should be consistent with broader public health goals and should not contribute to existing inequities in diabetes management.

scholarly journals Six-months of hybrid closed-loop versus manual insulin delivery with finger-prick blood glucose monitoring in adults with type 1 diabetes: a randomized, controlled trial

2020 ◽  
Author(s):  
Sybil A McAuley ◽  
Melissa H Lee ◽  
Barbora Paldus ◽  
Sara Vogrin ◽  
Martin I de Bock ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Closed Loop ◽  
Insulin Pump ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Diabetes Distress ◽  
Current Therapy ◽  
Control Group

OBJECTIVE <p>To investigate glycemic and psychosocial outcomes with hybrid closed loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump i.e. standard therapy for most adults with type 1 diabetes.</p> <p>RESEARCH DESIGN AND METHODS</p> <p>Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26-weeks HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked-CGM time-in-range (TIR; 70–180mg/dL) during the final 3 weeks. </p> <p>RESULTS</p> <p>Participants were randomized to HCL (<i>n</i>=61) or control (<i>n</i>=59). Baseline mean (SD) age 44.2(11.7)years; HbA<sub>1c</sub> 7.4(0.9)%, 57(10)mmol/mol; 53% were women and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15%; 95% CI 11, 19%; <i>p</i><0.0001). For HCL, HbA<sub>1c</sub> was lower (median [95% CI] difference −0.4% [−0.6, −0.2]; −4mmol/mol [−7, −2]; <i>p</i><0.0001) and diabetes-specific positive well-being higher (difference 1.2, 95% CI 0.4, 1.9; <i>p</i><0.0048) without a deterioration in diabetes distress, perceived sleep quality or cognition. Seventeen (nine device-related) vs. thirteen serious adverse events occurred in the HCL and control groups respectively.</p> <p>CONCLUSIONS</p> <p>In adults with type 1 diabetes 26 weeks of HCL improved TIR, HbA<sub>1c</sub> and their sense of satisfaction from managing their diabetes than those continuing with user-determined insulin dosing and self-monitoring blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable and advantageous.</p>

scholarly journals Six-months of hybrid closed-loop versus manual insulin delivery with finger-prick blood glucose monitoring in adults with type 1 diabetes: a randomized, controlled trial

2020 ◽  
Author(s):  
Sybil A McAuley ◽  
Melissa H Lee ◽  
Barbora Paldus ◽  
Sara Vogrin ◽  
Martin I de Bock ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Closed Loop ◽  
Insulin Pump ◽  
Glucose Monitoring ◽  
Blood Glucose Monitoring ◽  
Diabetes Distress ◽  
Current Therapy ◽  
Control Group

OBJECTIVE <p>To investigate glycemic and psychosocial outcomes with hybrid closed loop (HCL) versus user-determined insulin dosing with multiple daily injections (MDI) or insulin pump i.e. standard therapy for most adults with type 1 diabetes.</p> <p>RESEARCH DESIGN AND METHODS</p> <p>Adults with type 1 diabetes using MDI or insulin pump without continuous glucose monitoring (CGM) were randomized to 26-weeks HCL (Medtronic 670G) or continuation of current therapy. The primary outcome was masked-CGM time-in-range (TIR; 70–180mg/dL) during the final 3 weeks. </p> <p>RESULTS</p> <p>Participants were randomized to HCL (<i>n</i>=61) or control (<i>n</i>=59). Baseline mean (SD) age 44.2(11.7)years; HbA<sub>1c</sub> 7.4(0.9)%, 57(10)mmol/mol; 53% were women and 51% used MDI. HCL TIR increased from (baseline) 55% (13%) to (26 weeks) 70% (10%) with the control group unchanged: (baseline) 55% (12%) and (26 weeks) 55% (13%) (difference 15%; 95% CI 11, 19%; <i>p</i><0.0001). For HCL, HbA<sub>1c</sub> was lower (median [95% CI] difference −0.4% [−0.6, −0.2]; −4mmol/mol [−7, −2]; <i>p</i><0.0001) and diabetes-specific positive well-being higher (difference 1.2, 95% CI 0.4, 1.9; <i>p</i><0.0048) without a deterioration in diabetes distress, perceived sleep quality or cognition. Seventeen (nine device-related) vs. thirteen serious adverse events occurred in the HCL and control groups respectively.</p> <p>CONCLUSIONS</p> <p>In adults with type 1 diabetes 26 weeks of HCL improved TIR, HbA<sub>1c</sub> and their sense of satisfaction from managing their diabetes than those continuing with user-determined insulin dosing and self-monitoring blood glucose. For most people living with type 1 diabetes globally, this trial demonstrates that HCL is feasible, acceptable and advantageous.</p>

scholarly journals The Hypoglycaemia-Hyperglycaemia Minimizer System in the Management of Type 1 Diabetes

2016 ◽  
Vol 12 (1) ◽  
pp. 18
Author(s):  
Brian L Levy ◽  
◽  
Thomas W McCann ◽  
Jr and Daniel A Finan ◽  
◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Insulin Infusion ◽  
Closed Loop ◽  
Insulin Dose ◽  
Infusion Pump ◽  
Artificial Pancreas ◽  
Continuous Glucose Monitor ◽  
Glucose Levels

Living with type 1 diabetes (T1D) presents many challenges in terms of daily living. Insulin users need to frequently monitor their blood glucose levels and take multiple injections per day and/or multiple boluses through an insulin infusion pump, with the consequences of failing to match the insulin dose to the body’s needs resulting in hypoglycaemia and hyperglycaemia. The former can result in seizures, coma and even death; the latter can have both acute and long-term health implications. Many patients with T1D also fail to meet their treatment goals. In order to reduce the burdens of self-administering insulin, and improve efficacy and safety, there is a need to at least partially remove the patient from the loop via a closed-loop ‘artificial pancreas’ system. The Hypoglycaemia-Hyperglycaemia Minimizer (HHM) System, comprising a continuous, subcutaneous insulin infusion pump, continuous glucose monitor (CGM) and closed-loop insulin dosing algorithm, is able to predict changes in blood glucose and adjust insulin delivery accordingly to help keep the patient at normal glucose levels. Early clinical data indicate that this system is feasible, effective and safe, and has the potential to dramatically improve the therapeutic outcomes and quality of life for people with T1D.

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