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

OBJECTIVE 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. RESEARCH DESIGN AND METHODS 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. RESULTS Participants were randomized to HCL (n=61) or control (n=59). Baseline mean (SD) age 44.2(11.7)years; HbA1c 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%; p<0.0001). For HCL, HbA1c was lower (median [95% CI] difference −0.4% [−0.6, −0.2]; −4mmol/mol [−7, −2]; p<0.0001) and diabetes-specific positive well-being higher (difference 1.2, 95% CI 0.4, 1.9; p<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. CONCLUSIONS In adults with type 1 diabetes 26 weeks of HCL improved TIR, HbA1c 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.

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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

10.2337/figshare.13014374 ◽

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

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Six Months of Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring in Adults With Type 1 Diabetes: A Randomized, Controlled Trial

Diabetes Care ◽

10.2337/dc20-1447 ◽

2020 ◽

Vol 43 (12) ◽

pp. 3024-3033

Author(s):

Sybil A. McAuley ◽

Melissa H. Lee ◽

Barbora Paldus ◽

Sara Vogrin ◽

Martin I. de Bock ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Type 1 Diabetes ◽

Blood Glucose ◽

Closed Loop ◽

Controlled Trial ◽

Glucose Monitoring ◽

Insulin Delivery ◽

Blood Glucose Monitoring ◽

Randomized Controlled

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G479(P) Adherence to blood glucose monitoring in children and young people with type 1 diabetes on insulin pump therapy in a teaching hospital:

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-308599.433 ◽

2015 ◽

Vol 100 (Suppl 3) ◽

pp. A204.2-A205

Author(s):

S Punniyakodi ◽

PCB Sundaram ◽

JE Greening ◽

V Tziaferi

Keyword(s):

Type 1 Diabetes ◽

Blood Glucose ◽

Young People ◽

Insulin Pump ◽

Glucose Monitoring ◽

Blood Glucose Monitoring ◽

Insulin Pump Therapy ◽

Pump Therapy ◽

Children And Young People

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

Canadian Journal of Health Technologies ◽

10.51731/cjht.2021.50 ◽

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.

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999-P: Six Months At-Home Hybrid Closed-Loop vs. Manual Insulin Delivery with Finger-Stick Blood Glucose Monitoring in Adults with Type 1 Diabetes: A Randomized Controlled Trial

Diabetes ◽

10.2337/db20-999-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 999-P

Author(s):

SYBIL A. MCAULEY ◽

MELISSA H. LEE ◽

BARBORA PALDUS ◽

SARA VOGRIN ◽

MARY B. ABRAHAM ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Type 1 Diabetes ◽

Blood Glucose ◽

Closed Loop ◽

Controlled Trial ◽

Glucose Monitoring ◽

Blood Glucose Monitoring ◽

Randomized Controlled ◽

Finger Stick

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The advantages of insulin pump therapy and real time glucose monitoring systems as the tools for reducing the frequency of hypoglycemic episodes in the children and adolescents with type 1 diabetes mellitus

Problems of Endocrinology ◽

10.14341/probl201460224-30 ◽

2014 ◽

Vol 60 (2) ◽

pp. 24-30 ◽

Cited By ~ 3

Author(s):

D N Laptev

Keyword(s):

Type 1 Diabetes ◽

Blood Glucose ◽

Type 1 Diabetes Mellitus ◽

Real Time ◽

Insulin Pump ◽

Glucose Monitoring ◽

Blood Glucose Monitoring ◽

Insulin Pump Therapy ◽

Pump Therapy

The primary objective of the present study was to analyse the advantages of insulin pump therapy and real time glucose monitoring systems as the tools for reducing the frequency of hypoglycemic episodes. The study included 190 children and adolescents at the age varying from 1 to 18 years suffering from type 1 diabetes mellitus. All the patients were hospitalized at the Endocrinological Research Centre for the treatment the disease using different modalities of insulin therapy, such as multiple injections of insulin (MII) and its continuous subcutaneous infusion (CSII). The blood glucose level was monitored during 72 hours making use of the continuous blind and real time monitoring protocols (blind-CGM and RT-CGM respectively). All the patients were divided into 4 groups depending on the therapeutic modality and the mode of blood glucose monitoring. Group 1 was comprised of the patients given multiple insulin injections in combination with blind glucose monitoring ("blind-CGM + MII"), group 2 included the patients undergoing blind glucose monitoring in conjunction with continuous insulin infusion ("blind-CGM + CSII"), group 3 contained the patients treated by multiple insulin injections followed by real-time blood glucose monitoring ("RT-CGM + MII"), and group 4 was composed of the patients undergoing continuous subcutaneous infusion of insulin combined with real-time blood glucose monitoring ("RT-CGM + CSII"). In all the cases, the blood glucose levels were measured and the occurrence of hypoglycemia during the period of monitoring time was evaluated. It was shown that the highest frequency of hypoglycemia during 72 hours was recorded in the "blind-CGM" group and the lowest one in the RT-CGM groups. Despite adequate self-control, almost half of the patients in the "blind-CGM + MII" group reported at least one hypoglycemic episode either at the daytime or at night ; the duration of such episode was more than 1 hour on the average. In the "blind-CGM" group, CSII resulted in the decrease of the number of hypoglycemic episodes both at night and daytime (p<0.05). In the "RT-CGM + CSII" group, continuous insulin infusion reduced the mean duration of nocturnal hypoglycemic episodes (p<0.05) whereas this parameter was not significantly different between the other groups. It is concluded that hypoglycemia especially nocturnal one is rather a common problem facing children and adolescents suffering from type 1 diabetes mellitus. The use of insulin pump therapy and real time glucose monitoring systems (RT-CGM) makes it possible to substantially decrease the frequency and duration of hypoglycemic episodes in this population group.

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

Frontiers in Pediatrics ◽

10.3389/fped.2021.625390 ◽

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.

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