Among young patients with type 1 diabetes, insulin pump therapy, compared with insulin injection therapy, was associated with lower risks of severe hypoglycemia and diabetic ketoacidosis and with better glycemic control during the most recent year of therapy. These findings provide evidence for improved clinical outcomes associated with insulin pump therapy compared with injection therapy in children, adolescents, and young adults with type 1 diabetes.
The aim of this study was to correlate the frequency of self-monitoring of blood glucose (SMBG) to the quality of metabolic control as measured by hemoglobin A1c (HbA1c), the frequency of hypoglycemia and ketoacidosis, and to see whether the associations between SMBG and these outcomes are influenced by the patient's age or treatment regime. We analyzed data from the DPV-Wiss-database of 26 723 children and adolescents aged 0-18 yr with type 1 diabetes recorded during 1995-2006. Variables evaluated were gender, age at visit, diabetes duration, therapy regime, insulin dose, body mass index-standard deviation scores (BMI-SDS), HbA1c, rate of hypoglycemia, and ketoacidosis. In the youngest age group of children under the age of 6 yr, the frequency of SMBG was the highest compared with that in children aged 6-12 yr or children aged > 12 yr: 6.0/d vs. 5.3/d vs. 4.4/d (p < 0.001). Frequency of SMBG differed significantly also in the different groups of treatment (p < 0.001), but only for the continuous subcutaneous insulin infusion (CSII) group the frequency was considerably higher: 5.3/d (CSII) vs. 4.7/d (multiple daily injections) vs. 4.6/d (conventional therapy). Adjusted for age, gender, diabetes duration, year of treatment, insulin regimen, insulin dose, BMI-SDS, and center difference, SMBG frequency was significantly associated with better metabolic control with a drop of HbA1c of 0.20% for one additional SMBG per day (p < 0.001). Increasing the SMBG frequency above 5/d did not result in further improvement of metabolic control. A higher frequency of SMBG measurements was related to better metabolic control. But only among adolescents aged > 12 yr, metabolic control (HbA1c) improved distinctively with two or more blood glucose measurements.
DPV data indicate that an HbA1c of <7.5% can frequently be achieved in children with type 1 diabetes who are under 6 years old. An improved metabolic control of type 1 diabetes in young patients appears to decrease the risk of DKA without increasing SH. The greater frequency of suboptimal control in young patients in the T1DX compared with the DPV is not fully explained by a less frequent use of insulin pumps and may relate to the higher HbA1c targets that are recommended for this age group in the USA.
Employing a large cohort, this matched-pair analysis has demonstrated over a 3-year study period that CSII is a safe form of intensive insulin therapy with similar glycaemic effects, but with significantly reduced rates of hypoglycaemia and DKA and a lower insulin requirement when compared with MDI.
Objective
Continuous subcutaneous insulin infusion (CSII) is on the rise among pediatric patients with type 1 diabetes mellitus. Metabolic effects alone cannot explain this rising popularity. From the patient's perspective, the main benefits of CSII may be found in subjective psychosocial health outcomes (patient‐reported outcomes [PRO]).
Subjects and Methods
In a multicenter open randomized controlled trial, children and adolescents aged 6 to16 years currently treated with multiple daily injections (MDI) were randomized 1:1, stratified by center, to either starting with CSII immediately after the baseline interview or to continuing MDI while waiting 6 months for transmission to CSII. The primary outcomes were patient‐reported diabetes‐specific health‐related quality of life (DHRQOL) and diabetes burden of the main caregiver. Secondary outcomes were caregiver stress, fear of hypoglycemia, satisfaction with treatment, and HbA1c.
Results
Two‐hundred and eleven patients were randomized between February 2011 and October 2014, and 186 caregivers and 170 patients were analyzed using the intention‐to‐treat principle for primary outcomes. Children 8 to 11 years in the CSII group reported improved DHRQOL at follow‐up compared to MDI (median difference [MD] 9.5, 95% confidence interval [CI] 3.6‐16.7, P = 0.004). There were no treatment differences in the adolescent age‐group 12 to 16 years (MD 2.7; 95% CI −3.2‐9.5; P = 0.353). The main caregivers of the CSII group reported a significant decline of overall diabetes burden at follow‐up compared to the MDI group (MD 0; 95% CI −1‐0; P = 0.029). Secondary PROs also were in favor of CSII.
Conclusions
CSII has substantial psychosocial benefits. PROs demonstrate these benefits.
Registered as NCT01338922 at http://clinicaltrials.gov
The discontinuation rate of insulin pump therapy is, in general, low (4%). The younger the patients at the time of initiating insulin pump treatment, the lower is the discontinuation rate. The highest rate was seen in adolescents aged 10-15 yr. Girls stopped insulin pump treatment more often than boys (60.5% vs. 39.5%).
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