Hybrid Closed-Loop Control Is Safe and Effective for People with Type 1 Diabetes Who Are at Moderate to High Risk for Hypoglycemia

Anderson, Stacey M.; Buckingham, Bruce A.; Breton, Marc D.; Robic, J.; Barnett, Charlotte L.; Wakeman, Christian; Oliveri, Mary C.; Brown, Sue A.; Ly, Trang T.; Clinton, Paula; Hsu, Liana; Kingman, Ryan S.; Norlander, Lisa; Loebner, Sarah E.; Reuschel-DiVirglio, Suzette; Kovatchev, Boris

doi:10.1089/dia.2019.0018

Cited by 50 publications

(33 citation statements)

References 21 publications

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“…With the advancement of technology and closed loop systems many of the glucose metrics are improving including among them the number of hypoglycaemic events and their magnitude. Even in people at high risk for hypoglycaemia, there is currently only one Food and Drug Administration (FDA) approved system and the data were consistent with those findings 94‐96 …”

Section: Technology and Hypoglycaemiasupporting

confidence: 64%

Hypoglycaemia and its management in primary care setting

Ibrahim¹,

Baker

Cahn³

et al. 2020

Diabetes Metabolism Res

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Hypoglycaemia is common in patients with type 1 diabetes and type 2 diabetes and constitutes a major limiting factor in achieving glycaemic control among people with diabetes. While hypoglycaemia is defined as a blood glucose level under 70 mg/dL (3.9 mmol/L), symptoms may occur at higher blood glucose levels in individuals with poor glycaemic control. Severe hypoglycaemia is defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions to assure neurologic recovery. Hypoglycaemia is the most important safety outcome in clinical studies of glucose lowering agents. The American Diabetes Association Standards of Medical Care recommends that a management protocol for hypoglycaemia should be designed and implemented by every hospital, along with a clear prevention and treatment plan. A tailored approach, using clinical and pathophysiologic disease stratification, can help individualize glycaemic goals and promote new therapies to improve quality of life of patients. Data from recent large clinical trials reported low risk of hypoglycaemic events with the use of newer anti‐diabetic drugs. Increased hypoglycaemia risk is observed with the use of insulin and/or sulphonylureas. Vulnerable patients with T2D at dual risk of severe hypoglycaemia and cardiovascular outcomes show features of “frailty.” Many of such patients may be better treated by the use of GLP‐1 receptor agonists or SGLT2 inhibitors rather than insulin. Continuous glucose monitoring (CGM) should be considered for all individuals with increased risk for hypoglycaemia, impaired hypoglycaemia awareness, frequent nocturnal hypoglycaemia and with history of severe hypoglycaemia. Patients with impaired awareness of hypoglycaemia benefit from real‐time CGM. The diabetes educator is an invaluable resource and can devote the time needed to thoroughly educate the individual to reduce the risk of hypoglycaemia and integrate the information within the entire construct of diabetes self‐management. Conversations about hypoglycaemia facilitated by a healthcare professional may reduce the burden and fear of hypoglycaemia among patients with diabetes and their family members. Optimizing insulin doses and carbohydrate intake, in addition to a short warm up before or after the physical activity sessions may help avoiding hypoglycaemia. Several therapeutic considerations are important to reduce hypoglycaemia risk during pregnancy including administration of rapid‐acting insulin analogues rather than human insulin, pre‐conception initiation of insulin analogues, and immediate postpartum insulin dose reduction.

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Section: Technology and Hypoglycaemiasupporting

confidence: 64%

Hypoglycaemia and its management in primary care setting

Ibrahim¹,

Baker

Cahn³

et al. 2020

Diabetes Metabolism Res

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“…Despite these limitations, the comparisons tend to favour Diabeloop in the ways listed below. The reference time spent in the range of 3.9‐10.0 mmol/L was 23.9% (5.7 hours) longer with the Diabeloop CL system than with the OL systems. This value is in the upper range of those reported in the outpatient randomized clinical trials reviewed by Weisman et al (ie, published time‐in‐range values lie between 57% and 81%, with a −6% to 21% gain when compared with OL systems; see also Anderson et al, who reported an 18.6% gain, and Benhamou et al, who reported a 9.2% gain in a 12‐week study conducted in an ambulatory setting). Moreover, the percentage gain with the Diabeloop device is also higher than values obtained with commercially available hybrid CL devices in outpatients (14% gain found by Messer et al with the MiniMed670G, 10.3% reported by Lee et al with an enhanced version of the MiniMed670G, and 6.7% found by Biester et al with the DreaMed GlucoSitter) and in inpatients (5.7% found by Buckingham et al with a modified version of the OmniPod; see also the 10.8% gain with Tandem's Control‐IQ system as well as the clinical experience with the Medtronic 670G “hybrid” closed‐loop system presented at the American Diabetes Association's 79th Scientific Sessions).…”

Section: Discussionmentioning

confidence: 54%

Efficacy of the Diabeloop closed‐loop system to improve glycaemic control in patients with type 1 diabetes exposed to gastronomic dinners or to sustained physical exercise

Hanaire¹,

Franc

Borot

et al. 2019

Diabetes Obesity Metabolism

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Aims To compare closed‐loop (CL) and open‐loop (OL) systems for glycaemic control in patients with type 1 diabetes (T1D) exposed to real‐life challenging situations (gastronomic dinners or sustained physical exercise). Methods Thirty‐eight adult patients with T1D were included in a three‐armed randomized pilot trial (Diabeloop WP6.2 trial) comparing glucose control using a CL system with use of an OL device during two crossover 72‐hour periods in one of the three following situations: large (gastronomic) dinners; sustained and repeated bouts of physical exercise (with uncontrolled food intake); or control (rest conditions). Outcomes included time in spent in the glucose ranges of 4.4‐7.8 mmol/L and 3.9‐10.0 mmol/L, and time in hypo‐ and hyperglycaemia. Results Time spent overnight in the tight range of 4.4 to 7.8 mmol/L was longer with CL (mean values: 63.2% vs 40.9% with OL; P ≤ .0001). Time spent during the day in the range of 3.9 to 10.0 mmol/L was also longer with CL (79.4% vs 64.1% with OL; P ≤ .0001). Participants using the CL system spent less time during the day with hyperglycaemic excursions (glucose >10.0 mmol/L) compared to those using an OL system (17.9% vs 31.9%; P ≤ .0001), and the proportions of time spent during the day with hyperglycaemic excursions of those using the CL system in the gastronomic dinner and physical exercise subgroups were of similar magnitude to those in the control subgroup (18.1 ± 6.3%, 17.2 ± 8.1% and 18.4 ± 12.5%, respectively). Finally, times spent in hypoglycaemia were short and not significantly different among the groups. Conclusions The Diabeloop CL system is superior to OL devices in reducing hyperglycaemic excursions in patients with T1D exposed to gastronomic dinners, or exposed to physical exercise followed by uncontrolled food and carbohydrate intake.

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“…To our knowledge, no study has investigated closed‐loop systems in patients with a very high risk of hypoglycaemia (stage 4 of CPRs, highly unstable diabetes eligible for transplant) 2 . Anderson et al investigated people with T1D who were at moderate to high risk of hypoglycaemia (patients with previous ketoacidosis or severe hypoglycaemia were excluded, and the control group was equipped with a sensor‐augmented pump system without PLGS) 22 . After 4 weeks of closed‐loop home use, the time below 70 mg/dL was 2.0% 22 compared with 0.9% in the current study.…”

Section: Discussionmentioning

confidence: 99%

Patients with highly unstable type 1 diabetes eligible for islet transplantation can be managed with a closed‐loop insulin delivery system: A series of N‐of‐1 randomized controlled trials

Benhamou

Lablanche

Vambergue

et al. 2020

Diabetes Obesity Metabolism

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Aim To compare the efficacy of the closed‐loop Diabeloop for highly unstable diabetes (DBLHU) system with the open‐loop predictive low glucose suspend (PLGS) system in patients with highly unstable type 1 diabetes (T1D) who experience acute metabolic events. Methods DBLHU‐WP10 was an interventional, controlled, randomized, open‐label study that comprised two cycles of N‐of‐1 trials (2‐of‐1 trials). Each trial consisted of two crossover 4‐week periods of treatment with either DBLHU or PLGS in randomized order. The primary outcome was the percentage of time spent in the 70‐180 mg/dL glucose range (time in range [TIR]). Results Five out of seven randomized patients completed the aggregated 2‐of‐1 trials. TIR was significantly higher with DBLHU (73.3% ± 1.7%) compared with PLGS (43.5% ± 1.7%; P < .0001). The percentage of time below 70 mg/dL was significantly lower with DBLHU (0.9% ± 0.4%) versus PLGS (3.7% ± 0.4%; P < .0001). DBLHU was also significantly superior to PLGS in reducing hyperglycaemic excursions and improving almost all other secondary outcomes, including glucose variability and satisfaction score. No adverse event could be related to the experimental treatment. Conclusions DBLHU was superior to PLGS in improving the metabolic control of patients with highly unstable T1D who require an islet or pancreas transplant but who either have a contraindication or refuse to consent.

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Hybrid Closed-Loop Control Is Safe and Effective for People with Type 1 Diabetes Who Are at Moderate to High Risk for Hypoglycemia

Cited by 50 publications

References 21 publications

Hypoglycaemia and its management in primary care setting

Hypoglycaemia and its management in primary care setting

Efficacy of the Diabeloop closed‐loop system to improve glycaemic control in patients with type 1 diabetes exposed to gastronomic dinners or to sustained physical exercise

Patients with highly unstable type 1 diabetes eligible for islet transplantation can be managed with a closed‐loop insulin delivery system: A series of N‐of‐1 randomized controlled trials

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