Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries

Danne, Thomas; Battelino, Tadej; Jarosz-Chobot, Przemysława; Kordonouri, Olga; Pańkowska, Ewa; Ludvigsson, Johnny; Schober, Edith; Kaprio, Eero A.; Saukkonen, Tero; Nicolino, Marc; Tubiana‐Rufi, N.; Klinkert, Christof; Haberland, Holger; Vazeou, Andriani; Madácsy, László; Zangen, David; Cherubini, Valentino; Rabbone, Ivana; Toni, Sonia; Beaufort, Carine de; Waarde, Willie Bakker-van; Berg, N. van den; Волков, И Э; Barrio, Raquel; Hanås, Ragnar; Zumsteg, Urs; Kuhlmann, Beatrice; Aebi, C.; Schumacher, U.; Gschwend, Sylvia; Hindmarsh, Peter C.; Torres, M.; Shehadeh, Naim; Phillip, Moshe

doi:10.1007/s00125-008-1072-2

Cited by 128 publications

(127 citation statements)

References 29 publications

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“…The rate of severe events reported in this cohort (6.2 events of severe hypoglycaemia per 100 patient-years) is consistent with other reports in the literature: recently observed rates were 6.6 per 100 patient-years in a European pump cohort [13], 9.6 per 100 patient-years in Boston, MA, and Houston, TX, [17], and 6.9 and 4.4 per 100 patient-years for children <6 years and ≥6 years, respectively, in Israel [11].…”

Section: Discussionsupporting

confidence: 92%

“…We did observe reduced rates in adolescents treated with pump therapy. While some reports in the past have not observed this [18,19], our finding of reduced rates of severe hypoglycaemia in patients treated with pump therapy is supported by more recent reports in this age group [13,17], including a systematic review [20]. Because of the infrequency of hypoglycaemic convulsions and coma, no randomised trials can be powered to compare pump and injection therapy for hypoglycaemia prevention, and observational studies are the major source of evidence.…”

Section: Discussionsupporting

confidence: 69%

“…This may have resulted from improvements in therapy [13], suggesting that re-evaluation of the factors associated with severe events may be required. As a follow-up to the previously published analysis [1,10] and a subsequent update of rates of severe hypoglycaemia [3], our objectives for this study were to characterise the current epidemiology of, and risk factors for, severe hypoglycaemia in a contemporary child and adolescent population-based cohort.…”

Section: Introductionmentioning

confidence: 99%

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A population-based study of risk factors for severe hypoglycaemia in a contemporary cohort of childhood-onset type 1 diabetes

et al. 2013

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Aims/hypothesis Severe hypoglycaemia is a major barrier to optimising glycaemic control. Recent changes in therapy, however, may have altered the epidemiology of severe hypoglycaemia and its associated risk factors. The aim of this study was to examine the incidence rates and risk factors associated with severe hypoglycaemia in a contemporary cohort of children and adolescents with type 1 diabetes. Methods Subjects were identified from a population-based register containing data on >99% of patients (<16 years of age) who were being treated for type 1 diabetes in Western Australia. Patients attend the clinic approximately every 3 months, where data pertaining to diabetes management, demographics and complications including hypoglycaemia are prospectively recorded. A severe hypoglycaemic event was defined as an episode of coma or convulsion associated with hypoglycaemia. Risk factors assessed included age, duration of diabetes, glycaemic control, sex, insulin therapy, socioeconomic status and calendar year.Results Clinical visit data from 1,770 patients, providing 8,214 patient-years of data between 2000 and 2011 were analysed. During follow-up, 841 episodes of severe hypoglycaemia were observed. No difference in risk of severe hypoglycaemia was observed between age groups. Good glycaemic control (HbA 1c <7% [53 mmol/mol]) compared with the cohort average (HbA 1c 8-9% [64-75 mmol/mol]) was not associated with an increased risk of severe hypoglycaemia. When compared with patients on injection regimens, subjects aged 12-18 years on pump therapy were at reduced risk of severe hypoglycaemia (incidence risk ratio 0.6; 95% CI 0.4, 0.9). Conclusions/interpretation In this population-based sample of children and adolescents with type 1 diabetes, contemporary therapy is associated with a changed pattern and incidence of severe hypoglycaemia.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 69%

Section: Introductionmentioning

confidence: 99%

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A population-based study of risk factors for severe hypoglycaemia in a contemporary cohort of childhood-onset type 1 diabetes

et al. 2013

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“…The AP system improved safety compared with SAP, greatly decreasing the incidence of hypoglycemia, a fact of special relevance in this age population which is characterized by a higher frequency of hypoglycemic episodes (12), blunted sympathoadrenal response to falling blood glucose, and reduced warning symptoms and sluggish arousal from sleep (13). This beneficial effect was likely achieved by reducing the administration of basal insulin (25% less than during SAP).…”

Section: Discussionmentioning

confidence: 99%

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

et al. 2016

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OBJECTIVEThe Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5-to 9-yearold children during a camp. RESEARCH DESIGN AND METHODSA total of 30 children, 5-to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensoraugmented pump (SAP). RESULTSOvernight time-in-hypoglycemia was reduced with the AP versus SAP, median (25 th -75 th percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P 5 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P 5 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P 5 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P 5 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONSThis trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.Only three artificial pancreas (AP) trials have focused on the prepubertal population so far: two single-hormone AP studies, performed inpatient for less than 1 day (1,2) and a recent dual-hormone AP study, performed in a camp for 5 days (3). Here we report the first outpatient single-hormone AP trial focusing on 5-to 9-year-old children.Data were collected in the Pediatric Artificial Pancreas (PedArPan) camp, where sensor-augmented pump (SAP) therapy was compared with the modular model predictive control algorithm (MMPC) (4,5), running on the wearable platform Diabetes Assistant (DiAs) (6).

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“…This modality of treatment reduces the incidence of acute complications, not only hypoglycaemias but also ketoacidosis, together with improved metabolic control, increased adherence to the treatment and promotion of family involvement. Treatment with CIIS in the paediatric population is safe and efficacious and represents a valid option in selected patients of whatever age provided that there is always appropriate family and health-care professional support (Boland et al, 1999;Danne et al, 2008;DiMeglio et al, 2004). The results of the use of CIIS in pregestational diabetes have not been quite conclusive.…”

Section: Continuous Insulin Infusion Systems (Ciis)mentioning

confidence: 99%

Metabolic Control Targets for Patients with Type 1 Diabetes in Clinical Practice

Baena-Nieto¹,

López-Tinoco²,

Ortego-Rojo³

et al. 2011

Update on Mechanisms of Hormone Action - Focus on Metabolism, Growth and Reproduction

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Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries

Cited by 128 publications

References 29 publications

A population-based study of risk factors for severe hypoglycaemia in a contemporary cohort of childhood-onset type 1 diabetes

A population-based study of risk factors for severe hypoglycaemia in a contemporary cohort of childhood-onset type 1 diabetes

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

Metabolic Control Targets for Patients with Type 1 Diabetes in Clinical Practice

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