| 1. |
- Phillip, Moshe, et al.
(author)
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Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes
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In: Diabetes Care. - 1935-5548.
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Journal article (peer-reviewed)abstract
- Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programs are being increasingly emphasized. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk for (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in nonspecialized settings. To inform this monitoring, JDRF, in conjunction with international experts and societies, developed consensus guidance. Broad advice from this guidance includes the following: 1) partnerships should be fostered between endocrinologists and primary care providers to care for people who are IAb+; 2) when people who are IAb+ are initially identified, there is a need for confirmation using a second sample; 3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; 4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; 5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and 6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasizes significant unmet needs for further research on early-stage type 1 diabetes to increase the rigor of future recommendations and inform clinical care.
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| 2. |
- Phillip, Moshe, et al.
(author)
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Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes
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In: Diabetologia. - 1432-0428.
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Journal article (peer-reviewed)abstract
- Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programmes are being increasingly emphasised. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk of (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in non-specialised settings. To inform this monitoring, JDRF in conjunction with international experts and societies developed consensus guidance. Broad advice from this guidance includes the following: (1) partnerships should be fostered between endocrinologists and primary-care providers to care for people who are IAb+; (2) when people who are IAb+ are initially identified there is a need for confirmation using a second sample; (3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; (4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; (5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and (6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasises significant unmet needs for further research on early-stage type 1 diabetes to increase the rigour of future recommendations and inform clinical care.
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| 3. |
- Danne, Thomas, et al.
(author)
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A cross-sectional international survey of continuous subcutaneous insulin infusion in 377 children and adolescents with type 1 diabetes mellitus from 10 countries
- 2005
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In: Pediatric Diabetes. - 1399-543X .- 1399-5448. ; 6:4, s. 193-198
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Journal article (peer-reviewed)abstract
- Objective: To document current practices using continuous subcutaneous insulin infusion (CSII) by downloading electronically the 90-d pump data held within the pump memory and relating that to clinical data from children and adolescents in different pediatric diabetes centers from Europe and Israel. Methods: Data of patients (1-18 yr) treated with CSII in 23 centers from nine European countries and Israel were recorded with the ENCAPTURE software (PEC International, Frankfurt, Germany). The number of patients who participated was 377 (48% female, mean diabetes duration ± SD: 6.8 ± 3.7 yr, age: 12.9 ± 3.8 yr, preschool n = 33, prepubertal n = 95, adolescent n = 249, CSII duration: 1.6 ± 1.2 yr, local HbA1c: 8.1 ± 1.2%). Results: The total insulin dose was lower than previously reported for injection therapy (0.79 ± 0.20 U/kg/d). Covariance coefficient of daily total insulin was high in all age groups (adolescents 19 ± 9%, prepubertal 18 ± 8 and preschool 17 ± 8). The distribution of basal insulin infusion rates over 24 hr (48 ± 12% of total dose) varied significantly between centers and age groups. The number of boluses per day (7 ± 3) was not significantly different between the age groups (average daily bolus amount: 0.42 ± 0.16 U /kg). The rate of severe hypoglycemia (coma/convulsions) was 12.4 episodes per 100 patient-years and the number of diabetes-related hospital days was 124 per 100 patient-years. Discussion: Pediatric CSII patients show a high variability in their insulin therapy. This relates both to age-dependent differences in the distribution of basal insulin as to the age-independent day-to-day variation in prandial insulin. © Blackwell Munksgaard, 2005.
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| 4. |
- Danne, Thomas, et al.
(author)
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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
- 2008
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In: Diabetologia. - : Springer Science and Business Media LLC. - 0012-186X .- 1432-0428. ; 51:9, s. 1594-1601
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Journal article (peer-reviewed)abstract
- Aims/hypothesis: To assess the use of paediatric continuous subcutaneous infusion (CSII) under real-life conditions by analysing data recorded for up to 90 days and relating them to outcome. Methods: Pump programming data from patients aged 0-18 years treated with CSII in 30 centres from 16 European countries and Israel were recorded during routine clinical visits. HbA 1c was measured centrally. Results: A total of 1,041 patients (age: 11.8±4.2 years, diabetes duration: 6.0±3.6 years, average CSII duration: 2.0±1.3 years, HbA1c: 8.0±1.3% [means±SD]) participated. Glycaemic control was better in preschool (n=142, 7.5±0.9%) and pre-adolescent (6-11 years, n=321, 7.7±1.0%) children than in adolescent patients (12-18 years, n=578, 8.3±1.4%). There was a significant negative correlation between HbA1c and daily bolus number, but not between HbA1c and total daily insulin dose. The use of <6.7 daily boluses was a significant predictor of an HbA1c level >7.5%. The incidence of severe hypoglycaemia and ketoacidosis was 6.63 and 6.26 events per 100 patient-years, respectively. Conclusions/ interpretation: This large paediatric survey of CSII shows that glycaemic targets can be frequently achieved, particularly in young children, and the incidence of acute complications is low. Adequate substitution of basal and prandial insulin is associated with a better HbA1c. © 2008 Springer-Verlag.
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| 5. |
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| 6. |
- de Beaufort, Carine E., et al.
(author)
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Metabolic outcomes in young children with type 1 diabetes differ between treatment centers : the Hvidoere Study in Young Children 2009
- 2013
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In: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X .- 1399-5448. ; 14:6, s. 422-428
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Journal article (peer-reviewed)abstract
- Objective: To investigate whether center differences in glycemic control are present in prepubertal children <11yr with type 1 diabetes mellitus. Research Design and Methods: This cross-sectional study involved 18 pediatric centers worldwide. All children, <11 y with a diabetes duration 12months were invited to participate. Case Record Forms included information on clinical characteristics, insulin regimens, diabetic ketoacidosis (DKA), severe hypoglycemia, language difficulties, and comorbidities. Hemoglobin A1c (HbA1c) was measured centrally by liquid chromatography (DCCT aligned, range: 4.4-6.3%; IFFC: 25-45mmol/mol). Results: A total of 1133 children participated (mean age: 8.0 +/- 2.1 y; females: 47.5%, mean diabetes duration: 3.8 +/- 2.1 y). HbA1c (overall mean: 8.0 +/- 1.0%; range: 7.3-8.9%) and severe hypoglycemia frequency (mean 21.7 events per 100 patient-years), but not DKA, differed significantly between centers (p<0.001 resp. p=0.179). Language difficulties showed a negative relationship with HbA1c (8.3 +/- 1.2% vs. 8.0 +/- 1.0%; p = 0.036). Frequency of blood glucose monitoring demonstrated a significant but weak association with HbA1c (r=-0.17; p<0.0001). Although significant different HbA1c levels were obtained with diverse insulin regimens (range: 7.3-8.5%; p<0.001), center differences remained after adjusting for insulin regimen (p<0.001). Differences between insulin regimens were no longer significant after adjusting for center effect (p=0.199). Conclusions: Center differences in metabolic outcomes are present in children <11yr, irrespective of diabetes duration, age, or gender. The incidence of severe hypoglycemia is lower than in adolescents despite achieving better glycemic control. Insulin regimens show a significant relationship with HbA1c but do not explain center differences. Each center's effectiveness in using specific treatment strategies remains the key factor for outcome.
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| 7. |
- Hanås, Ragnar
(author)
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Reducing injection pain in children and adolescents with type 1 diabetes : Studies on indwelling catheters and injection needles
- 2001
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Doctoral thesis (other academic/artistic)abstract
- Insulin injections can be painful for many children, especially when using multiple daily injections. To reduce this procedural pain we in 1985 designed ao indwelling catheter for subcutaneous use when injecting insulin. This catheter has been well accepted by our patients. The aims of the present studies have been to further investigate the problems of pain associated with insulin injections in children and adolescents and to study side effects, metabolic control, and insulin absorption when using indwelling catheters (Insuflon®, Maersk Medical, Lynge, Denmark). Side effects and indwelling times were studied at home using questionnaires.Injection pain and needle phobia were studied using 10 cm VAS scales. Metabolic control was studied in a 10-week crossover study and insulin absorption with the help of an uncollimated gamma camera and 125I-insulin.The mean indwelling time was 4.8 ± 2.2 (range 0.5-17) days. Fixation problems and local redness at the insertion site were the most frequent side effects. No major infections requiring surgical or antibiotic treatment occurred. In the questionnaire of recalled pain, the VAS score of injections (median and quartiles) with syringes was 1.9 (1.1,3.5) cm, with pens 0.4 (0.2,1.3) cm, with indwelling catheters 0.4 (0.2, I. 7) cm, when taking a pump bolus dose 0.0 cm (0.0, 0.0), and when talcing a blood glucose test 0.7 (0.1, 2.4) cm. The injection pain and needle phobia declined with increasing age but some, both yOlmg children and teenagers, regarded the injection pain as almost unbearable. In the crossover study we found no significant difference between the arms with and without Insuflon in HbA1c, 24 hour profiles of blood glucose or serum free insulin. In the absorption study the patients used the same indwelling catheter for injections of short-acting insulin for 4 days. We found no significant difference in residual activity of 125 I-insulin after 60 min. or time to 50% remaining activity between injections day 1, 3 and 5, nor between catheter and ordinary injections on day 1, 3 and 5, respectively. HbA1c correlated significantly both to T-50% and residual activity of 125 I-insulin after 60 min. In the randomized multicenter study using Insuflon from the onset of diabetes, injection pain and parental pre-injection anxiety decreased from day 1-15 in both groups (in average 4.1 injections/day). Pain (median 1.7 cm vs. 2.7 cm, p=0.002) and parental pre-injection anxiety (1.2 cm vs. 2.9 cm, p=0.016) was lower for Insuflon users vs. ordinary injections. Talcing injections (including insertiug Insuflon) was found less problematic in the Insuflon group (1.6 cm vs. 3.3 cm, p=0.009). During the 6 month follow-up injection pain and injection problems were significantly lower in the Insuflon group. When comparing pen injector needles, the median VAS score ranged from 0. 7 cm to 1.2 cm in the first study where 27G and 28G needles were compared (n.s. ). In the following study, 280; 29G and 30G needles scored from 1.5 cm to 2.8 cm (n.s.). Placebo injections scored 0.1 cm (p=0.0001). Leakage of insulin was found in 14% of abdominal and 25% of thigh injections (p=0.0001) with no difference between the needles. VAS scores were higher in the later study which may be explained by the adding of faces to VAS, increasing the range of scores.In summary, most patients find the pain when injecting insulin quite small but for some it is almost unbearable. Needle diameter is of less importance for the expedenced injection pain. When using indwelling catheters from the onset of diabetes injection pain and pre-injection anxiety can be decreased significantly. The average indwelling time is 4-5 days and the frequency of side effects is low. Using indwelling catheters for up to 4 days does not affect the absorption of shmt-acting insulin when the catheter is inserted in an area free from lipohypertrophies and the long- and short-term metabolic control is not altered. We conclude that indwelling catheters can safely be used from the onset of diabetes to lessen injection pain in children and adolescents.
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| 8. |
- Hoey, Hilary, et al.
(author)
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Parent and health professional perspectives in the management of adolescents with diabetes : development of assessment instruments for international studies
- 2006
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In: Quality of Life Research. - : Springer Science and Business Media LLC. - 0962-9343 .- 1573-2649. ; 15:6, s. 1033-1042
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Journal article (peer-reviewed)abstract
- OBJECTIVE: Assessment of quality of life (QOL) in adolescents with diabetes requires patient, parent and health professional input. Psychometrically robust instruments to assess parent and professional perspectives are required. RESEARCH DESIGN AND METHODS: Questionnaires concerning adolescent QOL were developed for completion by parents and health professionals. In an international study assessing QOL in 2,101 adolescents with diabetes (median age 14 years, range 10-18; from 17 countries including Europe, Japan and North America), parents and health professionals completed their respective questionnaires between March and August 1998. RESULTS: Feasibility and acceptability of the new questionnaires were indicated by high questionnaire completion rates (adolescents 92%; parents 89%; health professionals 94%). Internal consistency was confirmed (Cronbach's alpha coefficients 0.80 parent; 0.86 health professional). Correlations of Diabetes Quality of Life Questionnaire for Youths (DQOLY) scores with parent and health professional global QOL ratings were generally low (r ranging from 0.12 to 0.36). Parent-rated burden decreased incrementally across adolescence, particularly for girls. Professional-rated burden followed a similar profile but only after age 15 years. Until then, burden was rated as uniformly high. Clinically relevant discrepancies in parent and professional burden scores were noted for one-parent families and families where adolescents had been referred for psychological help. In both cases, health professionals but not one-parent families perceived these as high burden situations. The clinical significance of this relates to the significantly poorer metabolic control recorded for adolescents in both situations. CONCLUSIONS: Parent and health professional questionnaires were found to have adequate internal consistency, and convergent and discriminant validity in relation to key clinical and QOL outcomes. The questionnaires are brief, easy to administer and score. They may also enable comparisons across countries and languages to facilitate development of international health outcome parameters. The inclusion of the parent and health professional perspectives completes a comprehensive assessment of adolescent QOL relevant to diabetes.
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| 9. |
- Knip, Mikael, et al.
(author)
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Effect of Hydrolyzed Infant Formula vs Conventional Formula on Risk of Type 1 Diabetes The TRIGR Randomized Clinical Trial
- 2018
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In: Journal of the American Medical Association (JAMA). - : AMER MEDICAL ASSOC. - 0098-7484 .- 1538-3598. ; 319:1, s. 38-48
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Journal article (peer-reviewed)abstract
- IMPORTANCE Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. DESIGN, SETTING, AND PARTICIPANTS An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the extensively hydrolyzed casein formula and 1078 to a conventional formula. The follow-up of the participants ended on February 28, 2017. INTERVENTIONS The participants received either a casein hydrolysate or a conventional adapted cows milk formula supplemented with 20% of the casein hydrolysate. The minimum duration of study formula exposure was 60 days by 6 to 8 months of age. MAIN OUTCOMES AND MEASURES Primary outcome was type 1 diabetes diagnosed according to World Health Organization criteria. Secondary outcomes included age at diabetes diagnosis and safety (adverse events). RESULTS Among 2159 newborn infants (1021 female [47.3%]) who were randomized, 1744 (80.8%) completed the trial. The participants were observed for a median of 11.5 years (quartile [Q] 1-Q3, 10.2-12.8). The absolute risk of type 1 diabetes was 8.4% among those randomized to the casein hydrolysate (n = 91) vs 7.6% among those randomized to the conventional formula (n = 82) (difference, 0.8%[95% CI, -1.6% to 3.2%]). The hazard ratio for type 1 diabetes adjusted for human leukocyte antigen risk group, duration of breastfeeding, duration of study formula consumption, sex, and region while treating study center as a random effect was 1.1 (95% CI, 0.8 to 1.5; P = .46). The median age at diagnosis of type 1 diabetes was similar in the 2 groups (6.0 years [Q1-Q3, 3.1-8.9] vs 5.8 years [Q1-Q3, 2.6-9.1]; difference, 0.2 years [95% CI, -0.9 to 1.2]). Upper respiratory infections were the most common adverse event reported (frequency, 0.48 events/year in the hydrolysate group and 0.50 events/year in the control group). CONCLUSIONS AND RELEVANCE Among infants at risk for type 1 diabetes, weaning to a hydrolyzed formula compared with a conventional formula did not reduce the cumulative incidence of type 1 diabetes after median follow-up for 11.5 years. These findings do not support a need to revise the dietary recommendations for infants at risk for type 1 diabetes.
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| 10. |
- Mortensen, Henrik B., et al.
(author)
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New definition for the partial remission period in children and adolescents with type 1 diabetes
- 2009
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In: Diabetes Care. - : American Diabetes Association. - 0149-5992 .- 1935-5548. ; 32:8, s. 1384-1390
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Journal article (peer-reviewed)abstract
- OBJECTIVE To find a simple definition of partial remission in type 1 diabetes that reflects both residual beta-cell function and efficacy of insulin treatment. RESEARCH DESIGN AND METHODS A total of 275 patients aged <16 years were followed from onset of type 1 diabetes. After 1, 6, and 12 months, stimulated C-peptide during a challenge was used as a measure of residual beta-cell function. RESULTS By multiple regression analysis, a negative association between stimulated C-peptide and A1C (regression coefficient -0.21, P < 0.001) and insulin dose (-0.94, P < 0.001) was shown. These results suggested the definition of an insulin dose-adjusted A1C (IDAA1C) as A1C (percent) + [4 x insulin dose (units per kilogram per 24 h)]. A calculated IDAA1C < or =9 corresponding to a predicted stimulated C-peptide >300 pmol/l was used to define partial remission. The IDAA1C < or =9 had a significantly higher agreement (P < 0.001) with residual beta-cell function than use of a definition of A1C < or =7.5%. Between 6 and 12 months after diagnosis, for IDAA1C < or =9 only 1 patient entered partial remission and 61 patients ended partial remission, for A1C < or =7.5% 15 patients entered partial remission and 53 ended, for a definition of insulin dose < or =0.5 units . kg(-1) . 24 h(-1) 5 patients entered partial remission and 66 ended, and for stimulated C-peptide (>300 pmol/l) 9 patients entered partial remission and 49 ended. IDAA1C at 6 months has good predictive power for stimulated C-peptide concentrations after both 6 and 12 months. CONCLUSIONS A new definition of partial remission is proposed, including both glycemic control and insulin dose. It reflects residual beta-cell function and has better stability compared with the conventional definitions.
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