Dataset Information

The durability and effectiveness of sensor-augmented insulin pump therapy in pediatric and young adult patients with type 1 diabetes.

ABSTRACT:

Purpose

Despite the prevalent use of insulin pump therapy worldwide, few studies have been conducted among young patients with type 1 diabetes (T1D) in Korea. We investigated the durability and effectiveness of insulin pump therapy among Korean pediatric and young adult patients with T1D.

Methods

This study included 54 patients with T1D diagnosed at pediatric ages (range, 1.1-14.1 years) who initiated insulin pump therapy during 2016-2019 at Seoul National University Children's Hospital and Seoul National University Bundang Hospital. Clinical and biochemical data, including anthropometric measurements, insulin dose, and glycated hemoglobin (HbA1c) levels were obtained from T1D diagnosis to last follow-up.

Results

Forty-four patients (81.5%) continued insulin pump therapy with a median pump use duration of 2.9 years (range, 0.2-3.5 years); 10 discontinued the therapy within 12 months (<1 month, n=6; 1-6 months, n=1; and 6-12 months, n=3) due to physical interferences or financial problems. Older age (?10 years of age) and longer diabetes duration (?2 years) at the initiation of pump therapy were associated with discontinuation (P<0.05 for both). For patients continuing pump therapy, HbA1c levels significantly decreased after 1 year of therapy (from 8.9% to 8.1%, P<0.001) without changes in the body mass index z-scores or insulin dose. Although 4 patients experienced diabetic ketoacidosis, all recovered without complications.

Conclusion

Insulin pump therapy was effective in improving glycemic control in T1D patients during 12 months of treatment. Early initiation of insulin pump therapy after T1D diagnosis was helpful for continuing therapy.

SUBMITTER: Lee YJ

PROVIDER: S-EPMC7788343 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The durability and effectiveness of sensor-augmented insulin pump therapy in pediatric and young adult patients with type 1 diabetes.

Lee Yun Jeong YJ Lee Young Ah YA Kim Jae Hyun JH Chung Hye Rim HR Gu Min Jeong MJ Kim Ji Young JY Shin Choong Ho CH

Annals of pediatric endocrinology & metabolism 20201231 4

<h4>Purpose</h4>Despite the prevalent use of insulin pump therapy worldwide, few studies have been conducted among young patients with type 1 diabetes (T1D) in Korea. We investigated the durability and effectiveness of insulin pump therapy among Korean pediatric and young adult patients with T1D.<h4>Methods</h4>This study included 54 patients with T1D diagnosed at pediatric ages (range, 1.1-14.1 years) who initiated insulin pump therapy during 2016-2019 at Seoul National University Children's Ho ...[more]

PMID: 33401881

Similar Datasets

Project description: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.

Project description:INTRODUCTION:Despite therapeutic advances, many individuals with type 1 diabetes are unable to achieve tight glycaemic target without increasing the risk of hypoglycaemia. The objective of this study is to determine the effectiveness of a 3-month day-and-night home closed-loop glucose control combined with a pump suspend feature, compared with sensor-augmented insulin pump therapy in youths and adults with suboptimally controlled type 1 diabetes. METHODS AND ANALYSIS:The study adopts an open-label, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design and aims for 84 randomised patients. Participants are youths (6-21 years) or adults (>21 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ?7.5% (58?mmol/mol) and ?10% (86?mmol/mol)). Following a 4-week run-in period, eligible participants will be randomised to a 3-month use of automated closed-loop insulin delivery combined with pump suspend feature or to sensor-augmented insulin pump therapy. Analyses will be conducted on an intention-to-treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0?mmol/L based on continuous glucose monitoring levels during the 3-month free-living phase. Secondary outcomes include HbA1c at 3 months, mean glucose, time spent below and above target; time with glucose levels <3.5?and <2.8?mmol/L; area under the curve when sensor glucose is <3.5?mmol/L, time with glucose levels >16.7?mmol/L, glucose variability; total, basal and bolus insulin dose and change in body weight. Participants' and their families' perception in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be evaluated. ETHICS AND DISSEMINATION:Ethics/institutional review board approval has been obtained. Before screening, all participants/guardians will be provided with oral and written information about the trial. The study will be disseminated by peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT02523131; Pre-results.

Project description:BACKGROUND:This prospective single-center study recruited insulin-resistant continuous subcutaneous insulin infusion (CSII) therapy-naive patients with type 2 diabetes (T2D) using insulin analog-based multiple daily injections (MDI) therapy and metformin. METHODS:A total of 23 individuals with T2D (70% male), aged a mean?±?standard deviation 57.2?±?8.03 years, with body mass index of 36.2?±?7.02?kg/m2, diabetes duration of 13.3?±?4.64 years, and HbA1c of 10.0%?±?1.05% were randomly assigned to a CSII arm or an MDI continuation arm to explore glucose control, weight loss, total daily insulin dose (TDD), and insulin resistance. Insulin dosing was optimized over a 2-month run-in period. RESULTS:At 6 months, patients assigned to the CSII arm achieved a significant mean HbA1c reduction of -0.9% (95% confidence interval [CI]?=?-1.6, -0.1), while reducing their TDD by -29.8?±?28.41?U/day (33% of baseline [92.1?±?20.35?U/day]) and achieving body mass (BM) reduction of -0.8?±?5.61?kg (0.98% of baseline [104.8?±?16.15?kg]). MDI patients demonstrated a nonsignificant HbA1c reduction of -0.3% (95% CI?=?-0.8, 0.1) with a TDD reduction of 5% from baseline (99.0?±?25.25?U/day to 94.3?±?21.25?U/day), and a BM reduction of -1.0?±?2.03?kg (0.99% of baseline [108.9?±?20.55?kg]). After 6 months, the MDI arm crossed over to CSII therapy. At 12 months, patients continuing CSII demonstrated an additional mean 0.7% HbA1c reduction with 54.6% achieving HbA1c<8%. The final TDD reduction was -9.7?U/day in comparison to baseline; BM increased by 1.1?±?6.5?kg from baseline. The MDI patients that crossed to CSII showed an HbA1c reduction of -0.5%?±?1.04%, HbA1c response rate of 27.3%, a TDD reduction of -17.4?±?21.06?U/day, and a BM reduction of -0.3?±?3.39?kg. Diabetic ketoacidosis or severe hypoglycemia did not occur in either arm. CONCLUSION:CSII therapy safely and significantly improved metabolic control with less insulin usage, with no sustainable reduction of BM, blood pressure, and lipid profile, in insulin-resistant T2D patients. Treatment adherence and satisfaction in these patients were excellent.

Dataset Information

The durability and effectiveness of sensor-augmented insulin pump therapy in pediatric and young adult patients with type 1 diabetes.

Purpose

Methods

Results

Conclusion

Publications

The durability and effectiveness of sensor-augmented insulin pump therapy in pediatric and young adult patients with type 1 diabetes.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets