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1.
Pediatr Diabetes ; 21(4): 649-656, 2020 06.
Article in English | MEDLINE | ID: mdl-32003490

ABSTRACT

BACKGROUND: Continuous subcutaneous insulin infusion (CSII) is commonly used in patients with diabetes. Accurate and reliable delivery by insulin pumps is essential for a safe and effective therapy, particularly when using small doses. In this study, accuracy of bolus and basal rate delivery of various available insulin pumps was evaluated. METHODS: In total, 13 insulin pump systems were tested: eight durable pumps with different infusion sets and one patch pump. Based on IEC 60601-2-24, insulin delivery was measured by recording weight gain of a beaker into which insulin was infused by the pumps. Bolus accuracy was determined by individually weighing 25 consecutive 0.1 or 1.0 U boluses and basal rate accuracy was determined during basal rate delivery of 0.1 or 1.0 U/h for 72 hours. For analyses, basal rate delivery was divided into 1-hour windows and deviation from target was calculated. RESULTS: Regarding different systems, average 0.1 U bolus delivery was -2% to +9% of the intended volume with 53% to 96% of boluses within ±15% of target. During 0.1 U/h basal rate delivery, most pumps showed an initial over-delivery for the first few hours. Three systems reached a total basal rate error <5%; others showed up to +24%. In general, delivery was more accurate when using larger doses. CONCLUSIONS: Considerable differences in insulin delivery accuracy were observed between the tested pumps. In general, when using very low doses, accuracy of insulin delivery is limited in most insulin pumps. This should be considered for CSII therapy in children.


Subject(s)
Insulin Infusion Systems , Insulin/administration & dosage , Adolescent , Child , Child, Preschool , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Drug Dosage Calculations , Equipment and Supplies/adverse effects , Equipment and Supplies/classification , Equipment and Supplies/standards , Humans , Injections, Subcutaneous , Insulin/adverse effects , Insulin Infusion Systems/adverse effects , Insulin Infusion Systems/classification , Insulin Infusion Systems/standards , Reproducibility of Results
2.
Pediatr Diabetes ; 18(4): 255-261, 2017 06.
Article in English | MEDLINE | ID: mdl-28425167

ABSTRACT

Continuous subcutaneous insulin infusion (CSII) is a very common therapy for children with type 1 diabetes. Due to physiological differences they have other requirements for their insulin pump than adults. The main difference is the need for very low basal rates. Even though most available insulin pumps reach a high accuracy at usual basal rates, accuracy decreases for lower rates. In addition, the lowest delivered amount at 1 time is limiting the fine tuning of the basal rate as well as the option for temporary basal rates. Alarms in case of occlusions depend on accumulation of a certain amount of insulin in the catheter, and therefore the time until such an alarm is triggered is much longer with lower basal rates. Accordingly, the risk for hyperglycemia developing into diabetic ketoacidosis increases. The availability of bolus advisors facilitates the calculation of meal and correction boluses for children and their parents. However, there are some differences between the calculators, and the settings that the calculation is based on are very important. Better connectivity, for example with a system for continuous glucose monitoring, might help to further increase safety in the use of CSII in children. When selecting an insulin pump for a child, the features and characteristics of available pumps should be properly compared to ensure an effective and safe therapy.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Hyperglycemia/prevention & control , Hypoglycemia/prevention & control , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Precision Medicine , Adolescent , Adolescent Behavior/drug effects , Adolescent Nutritional Physiological Phenomena/drug effects , Child , Child Behavior/drug effects , Child Nutritional Physiological Phenomena/drug effects , Combined Modality Therapy/adverse effects , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 1/therapy , Diabetic Ketoacidosis/etiology , Diabetic Ketoacidosis/physiopathology , Diabetic Ketoacidosis/prevention & control , Diet, Diabetic , Exercise , Humans , Hyperglycemia/physiopathology , Hypoglycemia/chemically induced , Hypoglycemia/physiopathology , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Infusions, Subcutaneous , Insulin/adverse effects , Insulin/therapeutic use , Insulin Infusion Systems/adverse effects , Severity of Illness Index
3.
Pediatr Diabetes ; 17(5): 311-8, 2016 08.
Article in English | MEDLINE | ID: mdl-26073672

ABSTRACT

BACKGROUND: The relationship between frequency and sustained bolus advisor (BA) use and glycemic improvement has not been well characterized in pediatric populations. OBJECTIVE: The objective of this study is to assess the impact of frequent and persistent BA use on glycemic control among pediatric type 1 diabetes patients. METHODS: In this 6-month, single-center, retrospective cohort study, 104 children [61 girls, mean age: 12.7 yr, mean HbA1c 8.0 (1.6)% [64 (17.5) mmol/mol]], treated with the Accu-Chek Aviva Combo insulin pump, were observed. Frequency of BA use, HbA1c, hypoglycemia (<70 mg/dL), therapy changes, mean blood glucose, and glycemic variability (standard deviation) was assessed at baseline and month 6. Sub-analyses of the adolescent patient use (12 months) and longitudinal use (24 months) were also conducted. RESULTS: Seventy-one patients reported high frequency (HF) device use (≥50%); 33 reported low frequency (LF) use (<50%) during the study. HF users achieved lower mean (SE) HbA1c levels than LF users: 7.5 (0.1)% [59 (1.1) mmol/mol] vs. 8.0 (0.2)% [64 (2.2) mmol/mol], p = 0.0252. No between-group differences in the percentage of hypoglycemia values were seen at 6 months. HF users showed less glycemic variability (84.0 vs. 94.7, p = 0.0045) than LF users. More HF patients reached HbA1c target of <7.5 at 6 months 66.2% (+16.9) vs. 27.3% (-9.1), p = 0.0056. Similar HbA1c results were seen in adolescents and BA users at 24 months. CONCLUSION: Frequent use of the Accu-Chek Aviva Combo insulin pump BA feature was associated with improved and sustained glycemic control with no increase in hypoglycemia in this pediatric population.


Subject(s)
Blood Glucose , Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/administration & dosage , Infusion Pumps, Implantable , Insulin/administration & dosage , Adolescent , Child , Child, Preschool , Female , Humans , Longitudinal Studies , Male , Retrospective Studies
4.
J Diabetes Sci Technol ; : 19322968241239870, 2024 Mar 26.
Article in English | MEDLINE | ID: mdl-38529954

ABSTRACT

BACKGROUND: In a randomized controlled trial, the efficacy of a digital diabetes diary regarding a reduction of diabetes distress was evaluated. METHODS: A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923). RESULTS: Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: -2.50 to 8.11) in the intervention group and 1.25 (IQR: -5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (-2.20, IQR: -4.02 to -0.38, P = .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group. CONCLUSIONS: The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.

5.
J Diabetes Sci Technol ; 17(4): 1049-1055, 2023 Jul.
Article in English | MEDLINE | ID: mdl-35466704

ABSTRACT

Recent in vitro experiments with patch pumps (PP) Omnipod (OP), Omnipod DASH (OP-D), A6 TouchCare (A6), and Accu-Chek Solo (ACS) have observed periodic fluctuations in the delivered amount of insulin during basal rate and consecutive bolus delivery in some PP, calling for a more systematic characterization of these periodic delivery patterns. Here, it was found that during basal rate delivery of 1 U/h, some devices of OP, OP-D, and A6 showed deviations of up to ±30% from target delivery that consistently repeated every 5 hours, whereas ACS showed no clear periodicity with considerably lower deviations. Similar results were found during consecutive bolus delivery of 1 U, where deviations repeated consistently every five boluses in some devices of OP, OP-D, and A6. However, there was a large variability in the periodic delivery patterns between individual devices of the same PP model. Examining their pumping techniques indicated a connection between the insulin delivery mechanism and observed delivery patterns of the PP. However, the clinical impact of such patterns is unclear.


Subject(s)
Hypoglycemic Agents , Insulin , Humans , Insulin Infusion Systems , Insulin, Regular, Human , Transdermal Patch
6.
BMC Fam Pract ; 13: 102, 2012 Oct 13.
Article in English | MEDLINE | ID: mdl-23062116

ABSTRACT

BACKGROUND: People with T1DM and insulin-treated T2DM often do not follow and/or adjust their insulin regimens as needed. Key contributors to treatment non-adherence are fear of hypoglycaemia, difficulty and lack of self-efficacy associated with insulin dose determination. Because manual calculation of insulin boluses is both complex and time consuming, people may rely on empirical estimates, which can result in persistent hypoglycaemia and/or hyperglycaemia. Use of automated bolus advisors (BA) has been shown to help insulin pump users to more accurately meet prandial insulin dosage requirements, improve postprandial glycaemic excursions, and achieve optimal glycaemic control with an increased time within optimal range. Use of a BA containing an early algorithm based on sliding scales for insulin dosing has also been shown to improve HbA1c levels in people treated with multiple daily insulin injections (MDI). We designed a study to determine if use of an automated BA can improve clinical and psychosocial outcomes in people treated with MDI. METHODS/DESIGN: The Automated Bolus Advisor Control and Usability Study (ABACUS) is a 6-month, prospective, randomised, multi-centre, multi-national trial to determine if automated BA use improves glycaemic control as measured by a change in HbA1c in people using MDI with elevated HbA1c levels (#62;7.5%). A total of 226 T1DM and T2DM participants will be recruited. Anticipated attrition of 20% will yield a sample size of 90 participants, which will provide #62;80% power to detect a mean difference of 0.5%, with SD of 0.9%, using a one-sided 5% t-test, with 5% significance level. Other measures of glycaemic control, self-care behaviours and psychosocial issues will also be assessed. DISCUSSION: It is critical that healthcare providers utilise available technologies that both facilitate effective glucose management and address concerns about safety and lifestyle. Automated BAs may help people using MDI to manage their diabetes more effectively and minimise the risk of long-term diabetes related complications. Findings from a recent study suggest that BA use positively addresses both safety and lifestyle concerns; however, randomised trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes. Our study is designed to make these assessments. TRIAL REGISTRATION: NCT01460446.


Subject(s)
Algorithms , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Drug Dosage Calculations , Glycated Hemoglobin/analysis , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Humans , Hyperglycemia/prevention & control , Hypoglycemia/prevention & control , Medication Adherence , Patient Satisfaction , Prospective Studies , Self Care , Treatment Outcome
7.
Diabetes Res Clin Pract ; 187: 109858, 2022 May.
Article in English | MEDLINE | ID: mdl-35367523

ABSTRACT

AIM: Patch pumps, i.e. insulin pumps without tubing, are an attractive alternative to conventional insulin pumps for people with type 1 diabetes and type 2 diabetes on insulin therapy. In this review, potential patient-relevant advantages and disadvantages of patch pumps are summarized and respective studies on patient-reported outcomes (PROs) are assessed. METHODS: Relevant studies were identified through a systematic PubMed search. Reference lists in respective articles and Google Scholar were also checked for additional references. Articles in English published before June 30, 2021, were included; no other criteria on publication dates were set. RESULTS: A total of 12 studies were included. The results of this analysis provide evidence that patch pumps improve quality of life, reduce diabetes-related distress, increase patient satisfaction, and are preferred by patients compared to conventional insulin pumps and multiple daily injection therapy (MDI). However, several methodological limitations of the studies identified constrain the significance of this analysis. CONCLUSIONS: Despite the limited number of studies evaluating the benefits of patch pumps on PROs, there is increasing evidence that people with diabetes prefer patch pumps. Although there are numerous PROs for patch pumps, it is surprising that this aspect has been relatively understudied. More systematic evaluation studies of the benefits of patch pumps on PROs are needed.


Subject(s)
Diabetes Mellitus, Type 1 , Diabetes Mellitus, Type 2 , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Insulin Infusion Systems , Quality of Life
8.
Diabetes Ther ; 13(5): 829-846, 2022 May.
Article in English | MEDLINE | ID: mdl-35416589

ABSTRACT

For decades, self-monitoring of blood glucose (SMBG) has been considered a cornerstone of adequate diabetes management. Structured SMBG can follow different monitoring patterns, and it results in improved glycemic control, reduced hypoglycemia, and a better quality of life of people with diabetes. The technology, usability, and accuracy of SMBG systems have advanced markedly since their introduction a few decades ago. Current SMBG systems are small and easy to use, require small (capillary) blood sample volumes, and provide measurement results within seconds. In addition, devices are increasingly equipped with features such as connectivity to other devices and/or digital diaries and diabetes management tools. Although measurement quality can come close to or equal that of the glucose monitoring systems used by healthcare professionals, several available SMBG systems still do not meet internationally accepted accuracy standards, such as the International Organization for Standardization 15197 standard. Reports from China, India, and Brazil based on local experience suggest that in addition of the accuracy issues of SMBG systems, other obstacles also need to be overcome to optimize SMBG usage. Nonetheless, adequate usage of SMBG data is of high relevance for the management of people with type 2 diabetes mellitus.

9.
J Diabetes Sci Technol ; 16(3): 775-782, 2022 05.
Article in English | MEDLINE | ID: mdl-35227075

ABSTRACT

Continuous subcutaneous insulin infusion (CSII) therapy is becoming increasingly popular. CSII provides convenient insulin delivery, precise dosing, easy adjustments for physical activity, stress, or illness, and integration with continuous glucose monitors in hybrid or other closed-loop systems. However, even as insulin pump hardware and software have advanced, technology for insulin infusion sets (IISs) has stayed relatively stagnant over time and is often referred to as the "Achilles heel" of CSII. To discuss barriers to insulin pump therapy and present information about advancements in, and results from clinical trials of extended wear IISs, Diabetes Technology Society virtually hosted the "Improving the Patient Experience with Longer Wear Infusion Sets Symposium" on December 1, 2021. The symposium featured experts in the field of IISs, including representatives from Steno Diabetes Center Copenhagen, University of California San Francisco, Stanford University, Medtronic Diabetes, and Science Consulting in Diabetes. The webinar's seven speakers covered (1) advancements in insulin pump therapy, (2) efficacy of longer wear infusion sets, and (3) innovations to reduce plastics and insulin waste.


Subject(s)
Diabetes Mellitus, Type 1 , Hypoglycemic Agents , Diabetes Mellitus, Type 1/drug therapy , Humans , Insulin , Insulin Infusion Systems , Patient Outcome Assessment
10.
J Diabetes Res ; 2022: 9604115, 2022.
Article in English | MEDLINE | ID: mdl-36561282

ABSTRACT

Aims: To investigate (1) daily, emotional, and physical caregiving burdens in parents of children with type 1 diabetes, (2) the sociodemographic and clinical predictors of three burdens, and (3) support measures that parents wish to receive. Methods: The study was a multicenter cross-sectional survey conducted in nine German pediatric diabetes centers. A questionnaire assessing three types of burdens and wishes for support was distributed to parents with a child with type 1 diabetes visiting one of the pediatric centers for a routine check-up. Results: Data from 1,107 parents (83% mothers) were analyzed. Parents reported significantly higher emotional burdens compared to daily and physical burdens (p < 0.0001). Mothers felt more burdened than fathers did. Parents of younger children reported higher daily and physical burdens compared to the parents of older children, and similarly, parents of technology users reported higher daily and physical burdens compared to the parents of nontechnology users. However, emotional burdens did not differ in both comparisons. Other demographic factors (i.e., parent's age, migration status, and single-parent family status) predicted high levels of daily or physical burdens, but only HbA1c level and the parent's gender (mother) predicted a high emotional burden. Independent of the level of burden, 78% of parents wanted additional diabetes training. Conclusion: Despite parents reporting high emotional burdens in connection with diabetes care, HbA1c and the gender of the reporting parent were the only risk factors. As the child gets older, parents' daily and physical distress decrease but not the emotional burden. Diabetes training including regularly offered booster sessions as well as low-threshold interventions for mental health issues and practical self-care skills is recommended to provide continuous support for parents.


Subject(s)
Diabetes Mellitus, Type 1 , Female , Humans , Child , Adolescent , Diabetes Mellitus, Type 1/therapy , Cross-Sectional Studies , Glycated Hemoglobin , Parents , Mothers
11.
Pediatr Diabetes ; 12(1): 11-7, 2011 Feb.
Article in English | MEDLINE | ID: mdl-20337978

ABSTRACT

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.


Subject(s)
Blood Glucose Self-Monitoring/statistics & numerical data , Diabetes Mellitus, Type 1/complications , Diabetic Ketoacidosis/epidemiology , Glycated Hemoglobin/metabolism , Hypoglycemia/epidemiology , Adolescent , Austria/epidemiology , Blood Glucose/metabolism , Child , Child, Preschool , Diabetes Mellitus, Type 1/blood , Diabetic Ketoacidosis/etiology , Female , Germany/epidemiology , Humans , Hypoglycemia/etiology , Insulin/administration & dosage , Male , Treatment Outcome
12.
J Diabetes Sci Technol ; 15(3): 684-694, 2021 05.
Article in English | MEDLINE | ID: mdl-32064909

ABSTRACT

In addition to the continuous use, the intermittent use of continuous glucose monitoring (CGM) is an application of CGM, expanding the typical medical use cases. There are a variety of reasons and occasions that speak in favor of using CGM only for a limited time. To date, these circumstances have not been sufficiently discussed. In this article, we define discontinuous or intermittent CGM use, provide reasons for using it, and expand on the benefits and possibilities of using CGM on a temporary basis. We aim to draw attention to this important topic in the discussion of CGM use and give examples for a different method of CGM use. As well, we would like to foster the allocation of CGM to the right patient groups and indications, especially in cases of limited resources. From a global point of view, intermittent CGM use is more likely to occur than continuous use, primarily for economic reasons.


Subject(s)
Blood Glucose Self-Monitoring , Blood Glucose , Humans
13.
Diabetes Technol Ther ; 23(5): 350-357, 2021 05.
Article in English | MEDLINE | ID: mdl-33210949

ABSTRACT

Background: Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared with the established patch pump Omnipod® (OP). Methods: Using a modified setup for tubeless pumps based on IEC 60601-2-24, the basal rate and bolus delivery of the Accu-Chek® Solo micropump system (ACS) and the A6 TouchCare® System (A6) were measured with a microgravimetric method. Bolus sizes of 0.2, 1, and 10 U, and basal rates of 0.1 and 1 U/h were evaluated in nine repetitions. For each parameter, mean deviation and number of individual boluses or 1-h basal rate windows within ±15% from target were calculated. In addition, occlusion detection time at basal rates of 0.1 and 1 U/h was determined. Results: Mean deviation of boluses of different volumes in the pumps ranged from -3.3% to +4.0% and 40%-100% of individual boluses were within ±15% of the target. During basal rate delivery, 48% to 98% of 1-h windows were within ±15% of the target with a mean deviation between -5.3% and +6.5%. In general, considerable differences between pump models were observed and deviations decreased with increasing doses. In most parameters, ACS was more accurate, and A6 less accurate, than OP. Mean occlusion detection time ranged from ∼3 to 7.5 h at 1 U/h and was >24 h or absent at 0.1 U/h. Conclusions: In this evaluation, significant differences between the tested tubeless pump models were observed that became most evident when regarding delivery errors over short time and small volumes.


Subject(s)
Diabetes Mellitus, Type 1 , Insulin Infusion Systems , Diabetes Mellitus, Type 1/drug therapy , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Insulin, Regular, Human/therapeutic use
14.
J Diabetes Sci Technol ; 15(4): 901-915, 2021 07.
Article in English | MEDLINE | ID: mdl-32476471

ABSTRACT

An increasing number of patients with type 2 diabetes mellitus (T2DM) use insulin pumps. The first insulin pumps especially designed for patients with T2DM have recently become available. However, national guidelines do not primarily recommend the use of continuous subcutaneous insulin infusion (CSII) for this patient group. The effectiveness of CSII in T2DM has not yet been convincingly demonstrated, despite some positive evidence. An overview and an assessment of various studies to date will be given. T2DM is a heterogeneous disease with a substantial phenotypic variability; therefore, it is difficult to provide general conclusions about the effectiveness of CSII in T2DM therapy. The pump types, characteristics, and associated barriers may play a relevant role for therapy outcome. Most advanced functions like various bolus dosages offered by conventional insulin pumps are not needed for T2DM treatment and complicate the device handling for this subject group. Additionally, new technologies like increased connectivity, advanced software features, and interoperability are currently becoming available representing further barriers. The implementation of this technological progress might be a benefit for pumps for T2DM as well. However, these have not been sufficiently examined either and increased security challenges due to integrated peripheral components should not be neglected in terms of a sound cybersecurity. Pump features and handling for patients with T2DM should be as easy as possible, indicating a need for insulin pumps specially designed for patients with T2DM. However, it has to be investigated if pumps designed for T2DM are more effective than other intensified insulin regimens.


Subject(s)
Diabetes Mellitus, Type 2 , Diabetes Mellitus, Type 2/drug therapy , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Insulin Infusion Systems
15.
Diabetes Technol Ther ; 23(3): 203-212, 2021 03.
Article in English | MEDLINE | ID: mdl-32924568

ABSTRACT

Background: The GoBolus study investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems. Methods: This 24-week, multicenter, single-arm, noninterventional study investigated adults with T1D (HbA1c, 7.5%-9.5%) receiving multiple daily injections (MDI) of insulin and using iscCGM within local healthcare settings for ≥6 months before switching to faster aspart at study start (week 0; baseline). Primary endpoint was HbA1c change from baseline to week 24. Exploratory endpoint was change in iscCGM metrics from baseline to week 24. Results: Overall, 243 patients were included (55.6% male), with mean age/diabetes duration, 49.9/18.8 years; mean HbA1c, 8.1%. By week 24, HbA1c had decreased by 0.19% (-2.1 mmol/mol, P < 0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data (n = 92): "time in range" (TIR; 3.9-10.0 mmol/L) increased from 46.9% to 50.1% (P = 0.01), corresponding to an increase of 46.1 min/day; time in hyperglycemia decreased from 49.1% to 46.1% (>10.0 mmol/L, P = 0.026) and 20.4% to 17.9% (>13.9 mmol/L, P = 0.013), corresponding to 43.5 (P = 0.024) and 35.6 (P = 0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (<3.9 and <3.0 mmol/L). Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L (P = 0.035) and 11.9 to 11.0 mmol/L (P = 0.002), respectively. Conclusion: Real-world switching to faster aspart in adults with T1D on MDI improved HbA1c, increased TIR, and decreased time in hyperglycemia without affecting time in hypoglycemia. The GoBolus study: NCT03450863.


Subject(s)
Diabetes Mellitus, Type 1 , Insulin Aspart , Adult , Aged , Blood Glucose , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/drug therapy , Female , Glycated Hemoglobin/analysis , Glycemic Control , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Insulin Aspart/therapeutic use , Male , Middle Aged
16.
Diabetes Care ; 44(12): 2656-2663, 2021 12.
Article in English | MEDLINE | ID: mdl-34697032

ABSTRACT

OBJECTIVE: To investigate the occupational and financial consequences for parents following the onset of type 1 diabetes in their child. RESEARCH DESIGN AND METHODS: A questionnaire assessing occupational and financial situations before and in the first year after the onset of diabetes was distributed to all families with a child ≤14 years of age at diagnosis with a diabetes duration of at least 12 months in nine German pediatric diabetes centers. RESULTS: Data of 1,144 children (mean age at diagnosis 6.7 [3.6] years; 46.5% female) and their families were obtained. Mothers' occupational status reflected in paid working hours was significantly reduced in the first year after their child's diabetes diagnosis (P < 0.001). Overall, 15.1% of mothers stopped working, and 11.5% reduced working hours. Mothers of preschool children were particularly affected. Fathers' working status hardly changed (P = 0.75). Nearly half of the families (46.4%) reported moderate to severe financial losses. Compared with an earlier similar study in 2003, significant negative occupational consequences for mothers and financial burden on families remained unchanged in 2018 (P = 0.59 and 0.31, respectively). CONCLUSIONS: Mothers of young children with newly diagnosed diabetes experienced negative consequences in their occupational situation. This inequality for mothers can have long-term negative consequences for their mental health and future economic situation. There is an urgent need for action to reduce the burden on families and to provide professional, social, and regulatory support, especially for mothers of young children with diabetes.


Subject(s)
Diabetes Mellitus, Type 1 , Mothers , Caregivers/economics , Caregivers/psychology , Caregivers/statistics & numerical data , Child , Child, Preschool , Cost of Illness , Diabetes Mellitus, Type 1/economics , Diabetes Mellitus, Type 1/epidemiology , Diabetes Mellitus, Type 1/psychology , Fathers/psychology , Fathers/statistics & numerical data , Female , Germany/epidemiology , Humans , Male , Mental Health , Mothers/psychology , Mothers/statistics & numerical data , Parents/psychology , Surveys and Questionnaires
17.
J Diabetes Sci Technol ; 14(3): 586-594, 2020 05.
Article in English | MEDLINE | ID: mdl-31718268

ABSTRACT

BACKGROUND: The ambulatory glucose profile (AGP) uses the wealth of data that are generated by continuous glucose monitoring, including flash glucose monitoring technologies, to provide a visual representation of glucose levels over a typical standard day of usually the most recent two weeks for a person with diabetes and helps to identify patterns and trends in glucose control. The AGP allows certain patterns of glucose levels to be identified and analyzed, such that treatment adjustments can be made, and new individual treatment goals can be defined. This helps to ensure increased treatment satisfaction and adherence, quality of life, and an improvement in metabolic management for people with diabetes. OBJECTIVE: To date, a range of approaches exists for interpreting the information contained in an AGP, with different priorities given to identifying and targeting patterns of hypoglycemia and the degree of variability and stability underlying the glucose levels. The objective of the present recommendation is to describe the steps for assessing an AGP in detail and to illustrate these steps using visual examples. CONCLUSION: This paper describes the consensus recommendations from a group of German expert diabetologists on the necessary steps for assessing an AGP in a structured and detailed way and to explain these steps using practical clinical examples.


Subject(s)
Blood Glucose Self-Monitoring/standards , Blood Glucose/metabolism , Diabetes Mellitus, Type 1/diagnosis , Diabetes Mellitus, Type 2/diagnosis , Biomarkers/blood , Blood Glucose/drug effects , Consensus , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/drug therapy , Evidence-Based Medicine/standards , Glycemic Control , Humans , Hypoglycemic Agents/therapeutic use , Predictive Value of Tests , Reproducibility of Results , Treatment Outcome
18.
Exp Clin Endocrinol Diabetes ; 128(9): 615-623, 2020 Sep.
Article in English | MEDLINE | ID: mdl-31426109

ABSTRACT

INTRODUCTION: Regarding pediatric diabetes, hospital admission for acute complications of type 1 diabetes (T1D) has often been investigated, but little is known about other causes of hospitalization. This study aimed to explore the total burden of hospitalization in individuals with diabetes<20 years of age in Germany. METHODS: Using the German Diagnosis-Related Groups data for 2015, we examined the frequencies of hospitalization with diabetes (20 251 inpatient cases), stratified by diabetes type [T1D, type 2 diabetes (T2D), other specified diabetes types (T3D), and unclear diabetes], and without diabetes (1 269 631 inpatient cases). Using estimates of the population at risk with T1D, T2D, and without diabetes, we evaluated hospitalization rates (per patient-year) by Poisson regression. For T1D, T2D, and T3D, we investigated the most frequent diagnoses and the median length of stay. Most analyses were stratified by sex, age-group and east/west residence. RESULTS: Children and adolescents with diabetes had a 6 to 9 times higher hospitalization risk than peers without diabetes (hospitalization rate 0.09). The hospitalization rate was higher for T2D compared with T1D (0.84 vs. 0.53, P<0.001). In T2D, two-third of inpatient cases were not directly related to diabetes, and stay was shorter compared with T1D and T3D (3 vs. 4 and 5 days, respectively). In T1D, hospitalization was more frequent among girls than boys (0.58 vs. 0.49, P<0.001), and mostly due to "diabetes without complications" (65.7%). Hospitalization tended to be more frequent and longer in the youngest patients, and in those with east residence. CONCLUSION: Hospitalization rate in pediatric diabetes in Germany remained high, especially for T2D patients, girls with T1D, and young children.


Subject(s)
Diabetes Mellitus, Type 1/epidemiology , Diabetes Mellitus, Type 2/epidemiology , Hospitalization/statistics & numerical data , Adolescent , Child , Child, Preschool , Comorbidity , Diabetes Mellitus, Type 1/therapy , Diabetes Mellitus, Type 2/therapy , Female , Germany/epidemiology , History, 21st Century , Hospitalization/trends , Humans , Infant , Infant, Newborn , Male , Patient Admission/statistics & numerical data , Patient Admission/trends , Pediatrics/statistics & numerical data , Young Adult
19.
J Diabetes Sci Technol ; 13(2): 259-260, 2019 03.
Article in English | MEDLINE | ID: mdl-30453763

ABSTRACT

Accuracy of sensors play an important role in the acceptance and long-term use of CGM which is related to improved glycemic outcome. This has been lower in children and adolescents in the past for reasons such as size of the device, pain, and necessity to calibrate sensors but also inaccuracy and perceived nonreliability on alarms among others. In the study of Welsh et al, performance of a new, factory-calibrated sensor was assessed. The accuracy of the sensor, as measured in MARD, paired values within 20/20% or 15/15% and surveillance error grid analysis showed very good results, although less so in low value range <70 mg/dL, falling rate of change, and on first day of use. Accurate glucose measurements especially in these incidences are of utmost importance to people with diabetes as their treatment decisions are based on these, also in the beginning of sensor use.


Subject(s)
Diabetes Mellitus, Type 1 , Adolescent , Blood Glucose , Blood Glucose Self-Monitoring , Child , Computer Systems , Humans , Insulin Infusion Systems
20.
Diabetes Technol Ther ; 21(4): 201-208, 2019 04.
Article in English | MEDLINE | ID: mdl-30901232

ABSTRACT

BACKGROUND: Insulin pumps are used for basal rate and bolus insulin delivery in patients with diabetes. In this in vitro study, accuracy of delivery of different commercial insulin pumps was evaluated. MATERIALS AND METHODS: Accuracy of 10 different insulin pump systems (5 durable pumps with different insulin infusion sets and 1 patch pump) was tested with a microgravimetric method. Mean bolus accuracy of 25 successive 1 U boluses and of 12 successive 10 U boluses was assessed, and delivery time for 10 U boluses was measured. Basal rate accuracy at 1.0 U/h was evaluated for 72 h and for individual 1-h windows. RESULTS: Mean bolus delivery was within ±5% of target for both tested bolus sizes, but precision of individual boluses was higher with the larger boluses. Delivery times varied between the different pump models but agreed with the specifications of the respective manufacturers. Regarding basal rate accuracy, the total deviation for 72 h was very small in all pumps; however, larger deviations were observed during the first 12 h. For the patch pump, large variations between individual 1-h windows were observed. CONCLUSIONS: In general, all compared insulin pump systems showed a similar level of accuracy. Differences, especially between durable pumps and the patch pump, were observed when considering each hour of basal rate delivery separately.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Materials Testing , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use
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