scholarly journals Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042790
Author(s):  
Julia Fuchs ◽  
Janet M Allen ◽  
Charlotte K Boughton ◽  
Malgorzata E Wilinska ◽  
Ajay Thankamony ◽  
...  
Keyword(s):  
Closed Loop ◽  
Diabetes Management ◽  
Insulin Pump ◽  
Open Label ◽  
Pump Therapy ◽  
Very Young Children ◽  
Sensor Glucose ◽  
The University ◽  
Target Glucose

IntroductionDiabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.Methods and analysisThe study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1–7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1–4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants’ and caregivers’ experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.Ethics and disseminationEthics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d’Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.Trial registration numberNCT03784027.

scholarly journals Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under free-living conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027856 ◽  
Author(s):  
Gianluca Musolino ◽  
Janet M Allen ◽  
Sara Hartnell ◽  
Malgorzata E Wilinska ◽  
Martin Tauschmann ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Children And Adolescents ◽  
Closed Loop ◽  
Insulin Pump ◽  
Insulin Delivery ◽  
Open Label ◽  
Pump Therapy ◽  
Glucose Levels ◽  
Sensor Glucose

IntroductionClosed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes.Methods and analysisThe trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ≥6 and <19 years) with type 1 diabetes for at least 1 year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ≥58 mmol/mol (7.5%) and ≤86 mmol/mol (10%)). After a 2–3 week run-in period, participants will be randomised to 6-month use of hybrid closed-loop insulin delivery, or to usual care. Analyses will be conducted on an intention-to-treat basis. The primary outcome is glycated haemoglobin at 6 months. Other key endpoints include time in the target glucose range (3.9–10 mmol/L, 70–180 mg/dL), mean sensor glucose and time spent above and below target. Secondary outcomes include SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5 mmol/L (63 mg/dL) and <3.0 mmol/L (54 mg/dL), area under the curve of glucose <3.5 mmol/L (63 mg/dL), time with glucose levels >16.7 mmol/L (300 mg/dL), area under the curve of glucose >10.0 mmol/L (180 mg/dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated.Ethics and disseminationCambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations.Trial registration numberNCT02925299; Pre-results.

Fasting during the holy month of Ramadan among older children and adolescents with type 1 diabetes in Kuwait

2019 ◽  
Vol 32 (8) ◽  
pp. 843-849 ◽  
Author(s):  
Kholoud Mohamed ◽  
Dalia Al-Abdulrazzaq ◽  
Amel Fayed ◽  
Eman El Busairi ◽  
Faisal Al Shawaf ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Children And Adolescents ◽  
Diabetes Management ◽  
Insulin Pump ◽  
Control Level ◽  
Insulin Pump Therapy ◽  
Insulin Regimen ◽  
Pump Therapy ◽  
Significant Difference

Abstract Background To evaluate the safety of fasting during the holy month of Ramadan among children and adolescent with type 1 diabetes (T1D). Methods A retrospective cohort study of 50 children and adolescents with T1D whose mean age was 12.7 ± 2.1 years was conducted. Twenty-seven patients (54%) were on multiple daily injections (MDI) insulin regimen and 23 (46%) were on insulin pump therapy. Before fasting for Ramadan, children and their families were evaluated and educated about diabetes management during Ramadan. Hemoglobin A1c (HbA1c), weight, number of days fasted, hypoglycemia and hyperglycemia episodes, and emergency hospital visits were collected and analyzed after completing the month. Participants were compared according to the insulin treatment regimen and their glycemic control level before Ramadan. Results The children were able to fast 20 ± 9.9 days of Ramadan, and the most common cause for breaking the fast was mild hypoglycemia (7.8% among all cases). There was no significant difference between the two insulin regimen groups in breaking fast days, frequency of hypo- or hyperglycemia, weight and HbA1c changes post Ramadan. Patients with HbA1c ≤ 8.5% were able to fast more days during Ramadan with significantly less-frequent hypoglycemic attacks as compared to patients with HbA1c > 8.5 (1.2 ± 1.5 vs. 3.3 ± 2.9 days of hypoglycemia, p = 0.01, respectively). Conclusions Fasting for children with T1D above the age of 10 years is feasible and safe in both pump and non-pump users, and well-controlled patients are less likely to develop complications. Education of the families and their children before Ramadan, along with intensive monitoring of fasting children during the month are crucial.

scholarly journals Self-Management Behaviors in Adults on Insulin Pump Therapy

2016 ◽  
Vol 11 (2) ◽  
pp. 233-239 ◽  
Author(s):  
Danielle Groat ◽  
Maria Adela Grando ◽  
Hiral Soni ◽  
Bithika Thompson ◽  
Mary Boyle ◽  
...  
Keyword(s):  
Diabetes Management ◽  
Insulin Pump ◽  
Real Life ◽  
Insulin Pump Therapy ◽  
Self Management ◽  
Pump Therapy ◽  
Adult Participants ◽  
Glycemic Outcomes ◽  
Management Behaviors

Background: Successful diabetes management requires behavioral changes. Little is known about self-management behaviors (SMB) in adults on insulin pump (IP) therapy. Objective: Analyze and characterize observed common diabetes SMB in adult participants with type 1 diabetes (T1D) using IPs and to correlate behaviors with glycemic outcomes based on participant’s individual glucose targets. Materials and Methods: One month of IP data from adults with T1D were downloaded. Computer programs were written to automatically quantify the observed frequency of expected behaviors such as: insulin bolusing, checking blood glucose (BG), and recording carbohydrate intake, and other interactions with the IP. Results: Nineteen participants were recruited and 4,249 IP interactions were analyzed to ascertain behaviors. Intersubject variability of adherence to minimally expected behaviors was observed: daily documentation of carbohydrates and BG checks in 76.6 (31.7)% and 60.0 (32.5)%, respectively, and bolusing without consulting the IPBC in 13.0 (16.9)% of delivered boluses, while daily insulin bolus delivery was consistent 96.8 (5.7)%. Higher frequency of adherence to daily behaviors correlated with a higher number of glucose readings at target. Conclusion: Results indicate variability in SMB and do not always match recommendations. Case-scenarios based on observed real-life SMB could be incorporated into interviews/surveys to elucidate ways to improve SMB.

scholarly journals Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes

2021 ◽  
Author(s):  
Olivia J Collyns ◽  
Renee A Meier ◽  
Zara L Betts ◽  
Denis SH Chan ◽  
Chris Frampton ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Insulin Delivery ◽  
Target Range ◽  
Study Phase ◽  
Pump Therapy ◽  
Set Point ◽  
Sensor Glucose ◽  
Low Glucose

Objective:<br><p> To study the MiniMed™ Advanced Hybrid Closed-Loop system (AHCL) which includes an algorithm with individualised basal target set points, automated correction bolus function, and improved Auto Mode stability.<br> Research design and Methods:</p> <p>This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve participants with type 1 diabetes (aged 7-80yrs), compared AHCL to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP+PLGM). Each study phase was 4 weeks, preceded by a 2-4 week run-in, and separated by 2-week washout.</p> <p><a>Results:<b> </b><br> 59/60 people completed the study (mean age 23.3±14.4yrs). Time in target range (TIR) 3.9-10mmol/L (70-180 mg/dL) favoured AHCL over SAP+PLGM (</a>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±16.2mg/dL) and improved with AHCL (8.5±0.7mmol/L (153±12.6mg/dL) (p < 0.001)), but deteriorated during PLGM (9.5±1.1mmol/L (17±19.8mg/dL), (p<0.001)).. TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared to 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. <a>The percentage of hypoglycemia at baseline (<3.9mmol/L (70mg/dl) and </a> £ 3.0mmol/L(54mg/dl)) was 3.1±2.1% and 0.5±0.6% respectively. During AHCL percentage time <3.9mmol/L (70mg/dl) improved to 2.1±1.4% (p=0.034) (70mg/dl), and was statistically but not clinically reduced for £ 3.0mmol/L(54mg/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.</p> <p>Conclusions</p> <p>AHCL with automated correction bolus demonstrated significant improvement in glucose control compared to SAP+PLGM. A lower algorithm sensor glucose set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.</p>

scholarly journals Generic and disease-specific quality of life in adolescents with type 1 diabetes: comparison to age-matched healthy peers

2016 ◽  
Vol 29 (7) ◽  
Author(s):  
Andrea Lukács ◽  
Péter Sasvári ◽  
András Török ◽  
László Barkai
Keyword(s):  
Quality Of Life ◽  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Diabetes Management ◽  
Insulin Pump ◽  
Insulin Pump Therapy ◽  
Regular Exercise ◽  
Pump Therapy

AbstractThis study aimed to evaluate the health-related quality of life (HRQoL) of adolescents with type 1 diabetes (T1DM) on the basis of the pediatric quality of life inventory™ (PedsQL™) generic and diabetes-specific modules, and to compare it to that of healthy peers.This retrospective case-control study involved 650 participants between ages of 13 and 19 years including 296 adolescents with T1DM from four diabetes centers and 354 healthy peers matched for age and gender from three different cities of the country. Participants completed the validated PedsQL™ for assessing the HRQoL. The analysis included an independent t-test to compare the means of the total and subscales of the PedsQL™ between boys and girls as well as between a healthy group and a group with T1DM. Gender differences in exercise, insulin therapy modalities were evaluated with the Pearson χAdolescents with T1DM have similar HRQoL in all domains when compared to their healthy counterparts. Females report worse HRQoL regardless of the presence of the disease. Insulin pump therapy facilitates better glycemic control and HRQoL. Regular exercise positively correlates with the generic HRQoL in both groups; however, it has no relationship with glycemic control.Optimal metabolic control and improved HRQoL are the eventual goals of diabetes management. Despite the difficulties, adolescents with diabetes can manage their disease well and live normal lives, similar to their healthy peers. Although diabetes-related problems exist, it seems that regular exercise and staying physically active, as well as promoting insulin pump therapy where it is applicable are related to favorable HRQoL.

scholarly journals Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial

2021 ◽  
Author(s):  
Helga Blauw ◽  
A. Joannet Onvlee ◽  
Michel Klaassen ◽  
Arianne C. van Bon ◽  
J. Hans DeVries
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Control ◽  
Closed Loop ◽  
Insulin Pump ◽  
Artificial Pancreas ◽  
Open Loop ◽  
Insulin Pump Therapy ◽  
Pump Therapy ◽  
Randomized Crossover Trial

OBJECTIVE <p>To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas in adults with type 1 diabetes.</p> <p> </p>RESEARCH DESIGN AND METHODS <p>In this outpatient, randomized, crossover trial, two-week fully closed loop glucose control (artificial pancreas therapy) was compared to two-week open loop control (patient’s normal insulin pump therapy with a glucose sensor if they had one). </p> <p> </p>RESULTS <p>Twenty three patients were included in the analysis. Median (IQR) time in range (70-180 mg/dL [3.9-10 mmol/L]) was significantly higher during closed loop (86.6% [84.9-88.5]) compared with open loop (53.9% [49.7-67.2]; p<0.0001).</p> <p> </p>CONCLUSIONS <p>Compared to insulin pump therapy, the bihormonal artificial pancreas provided superior glucose control, without meal or exercise announcements, and was safe in adults with type 1 diabetes.</p>

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