| 1. |
- Danne, Thomas, et al.
(författare)
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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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Ingår i: Pediatric Diabetes. - 1399-543X .- 1399-5448. ; 6:4, s. 193-198
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Tidskriftsartikel (refereegranskat)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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| 2. |
- Enander, Rebecka, et al.
(författare)
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Beta cell function after intensive subcutaneous insulin therapy or intravenous insulin infusion at onset of type 1 diabetes in children without ketoacidosis.
- 2018
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Ingår i: Pediatric diabetes. - : Hindawi Limited. - 1399-5448 .- 1399-543X. ; 19:6, s. 1079-1085
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Tidskriftsartikel (refereegranskat)abstract
- Our aim was to see if IV insulin therapy at diagnosis preserves beta-cell function better than multiple subcutaneous (SC) injections.Fifty-four children 9.9 ± 3.5years (range 2.8-14.9) without ketoacidosis were included in a 2years, randomized multicenter study with insulin SC or 48 to 72hours IV initially. Thirty-three (61%) were boys, 22 (41%) were pubertal. Forty-eight subjects completed 12 months follow-up and 43 completed 24 months. At 1, 6, 12, and 24 months, hemoglobin A1c (HbA1c), C-peptide and insulin/kg/24 h were measured. At 24 months, a mixed-meal tolerance test (MMTT) was performed.HbA1c at diagnosis was 10.7%, (93mmol/mol) for IV, 10.7%, (94mmol/mol) for SC. During the first 2 full days of insulin therapy, mean plasma glucose was 8.2 mmol/L for IV, 9.5 for SC (P =.025). Mean insulin dose was 1.5 U/kg/d for IV vs 1.0 for SC (P =.001). Sixteen (7 in IV, 9 in SC group) started with insulin pumps during the follow-up. At 24 months, we saw no significant differences: HbA1c (7.5%, 58mmol/mol, for IV, 7.2%, 55mmol/mol, for SC; ns), insulin doses (0.79 vs 0.88U/kg/d; ns), fasting C-peptide (0.08 vs 0.12nmol/L; ns), maximal MMTT response (0.19 vs 0.25nmol/L; ns) and AUC (18.26 vs 23.9 nmol/L*min; ns). Peak C-peptide >0.2 nmol/L in the combined IV and SC groups correlated significantly with HbA1c and C-peptide at onset in a multiple regression.Residual beta cell function at 2years seems to be independent from initial insulin regimens but related to HbA1c and C-peptide at onset.
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| 3. |
- Hanås, Ragnar, et al.
(författare)
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Experience of pain from insulin injections and needle-phobia in young patients with IDDM
- 1997
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Ingår i: Practical Diabetes International. - : Wiley. - 1357-8170 .- 1528-252X. ; 14:4, s. 95-99
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Tidskriftsartikel (refereegranskat)abstract
- We studied attitudes towards insulin injections, needle-phobia and the experience of pain when using syringes, pens, insulin pumps and in-dwelling subcutaneous catheters (Insuflon®, Maersk Medical, Lynge, Denmark).185 children and adolescents with IDDM aged 14.2±4.1 years with a HbA1c of 6.4±1.4% answered a questionnaire using 10 cm VAS scores (0 cm = hardly noticeable pain/not scared of needles at all, 10 cm=unbearable pain, very scared of needles).The VAS score of injections (median and quartiles) with syringes was 1.9 (1.1, 3.5) cm, with pens 0.4 (0.0, 1.3) cm, with in-dwelling catheters 0.4 (0.2, 1.7) cm, when taking a bolus dose with insulin pump 0.0 (0.0, 0.0) cm and when taking a blood glucose test 0.7 (0.1, 2.4) cm. The injection pain declined with increasing age but still several teenagers regarded the injection pain as almost unbearable. Injection pain correlated to HbA1c (p=0.033), age (p=0.0003), their own (p<0.0001) and their mother's (p=0.032) needle-phobia (but not father's) but not to diabetes duration or if parents had tried injections or blood glucose testing. Median needle-phobia score was 0.4 (0.1, 1.4) cm. Overall, 8.3% of the patients, 16.8% of the mothers and 17.7% of the fathers defined themselves as having pronounced needle-phobia (⩾5 cm). Those using in-dwelling catheters reported a higher needle-phobia but their injection pain was in the same low range as for other individuals.We conclude that, for most patients, the pain when injecting insulin is quite small irrespective of injection mode, but for some it is almost unbearable. Parents' attitudes are important for children's acceptance of injections. Injections through an in-dwelling injection aid enables children and adolescents to reduce the pain to levels comparable to those who are less needle-phobic.
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| 4. |
- Hanås, Ragnar, et al.
(författare)
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Hypoglycemia and ketoacidosis with insulin pump therapy in children and adolescents
- 2006
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Ingår i: Pediatric Diabetes. - 1399-543X .- 1399-5448. ; 7:Supp. 4, s. 32-38
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Tidskriftsartikel (refereegranskat)abstract
- This review deals with the two most serious side effects encountered with insulin pump therapy, severe hypoglycemia and diabetic ketoacidosis (DKA). Although clinical follow-up studies reported decreased rates of severe hypoglycemia, randomized studies have not confirmed this, showing no difference between the pump and injection groups. Less-severe hypoglycemia (mild/moderate/symptomatic hypoglycemia) was found to be more common with pump use. Some patients have inadvertently dosed or overdosed while awake or during sleep, causing fatal outcome in rare cases. Population-based or retrospective clinical studies reported a low rate of DKA in pump users that was still a higher rate than those using injection therapy, at least in some countries. In research settings and for patients with good compliance and adequate family support, the risk of DKA seems lower; many short-term studies report no DKA at all, possibly due to the increased attention given to participants. The use of continuous subcutaneous insulin infusion (CSII) seems to decrease the risk in patients who had recurrent DKA before pump start. Most episodes of DKA occur early after pump start, suggesting a learning curve occurs in all new forms of treatment. Increased teaching and awareness programs are vital to prevent severe hypoglycemia and DKA in children and adolescents using insulin pumps.
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| 5. |
- Hanås, Ragnar, 1951, et al.
(författare)
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Indwelling catheters used from the onset of diabetes decrease injection pain and pre-injection anxiety
- 2002
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Ingår i: J Pediatr. - : Elsevier BV. - 0022-3476 .- 0022-3476 .- 1097-6833. ; 140:3, s. 315-20
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To investigate the use of indwelling catheters as injection aids at diabetes onset to reduce injection pain and pre-injection anxiety. STUDY DESIGN: Forty-one patients aged 8.1 +/- 3.7 years (range, 1-15) participated in this open, controlled randomized study. A 10-cm VAS with faces was used for scoring. A local anesthetic cream was used before all insertions. The control group used insulin pens with standard needles. After one week, the indwelling catheter group could choose regular injections but were included in the "intention to treat" analysis. RESULTS: Injection pain and anxiety decreased from day 1 to 15 in both groups (average, 4.1 injections/day). Pain was significantly lower for indwelling catheter injections when scored by parents (median, 1.2 cm vs 2.7 cm; P =.002), children/teenagers (0.8 cm vs 1.5 cm; P =.006), and nurses (1.4 cm vs 3.0 cm; P =.002). Parental pre-injection anxiety was also lower (1.2 cm vs 2.9 cm; P =.016). Taking injections, including inserting catheters, was found to be less problematic with an indwelling catheter (1.6 cm vs 3.3 cm;P =.009). During the 6-month follow-up, injection pain and injection problems were significantly lower in the catheter group. Mean catheter indwelling time was 3.7 days. Median pain for catheter insertion was 2.1 cm and for glucose testing was 0.9 cm. Sixteen of 20 patients continued to use indwelling catheters after 2 weeks, and 9 of 20 after 6 months. CONCLUSIONS: We found an evident relief of pre-injection anxiety and injection pain when using indwelling catheters for introducing insulin injections at the onset of diabetes.
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| 6. |
- Hanås, Ragnar, et al.
(författare)
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Metabolic Control Is Not Altered When Using Indwelling Catheters for Insulin Inactions
- 1994
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Ingår i: Diabetes Care. - : American Diabetes Association. - 0149-5992 .- 1935-5548. ; 17:7, s. 716-718
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE To determine if the use of indwelling catheters for insulin injections affects the long- and short-term metabolic control of insulin-dependent diabetes mellitus (IDDM).RESEARCH DESIGN AND METHODS Sixteen children and adolescents 9–20 years of age were included in a randomized 10-week crossover study using indwelling catheters (Insuflon, Pharma-Plast, Lynge, Denmark; CHRONIMED, Minnetonka, Minnesota) for insulin injections. Their diabetes duration was 7.5 ± 3.3 years (range 2–14), and they used multiple injection therapy with 4–5 doses/day. C-peptide was <0.15 nM fasting and ≤0.30 nM postprandial.RESULTS We found no significant difference between those with and without Insuflon in degree of metabolic control reflected by HbA1c (with Insuflon, 7.3 ± 2.6%; without, 7.1 ± 2.2%), 24-h profiles of blood glucose and free insulin, 24-h samples of glucosuria, or ketonuria. Weight, insulin doses per kilogram per 24 h, and insulin antibodies were all the same in the two groups.CONCLUSIONS The long- and short-term metabolic control of IDDM was not altered by the use of indwelling catheters for insulin injections. Insuflon can be offered as an alternative to patients with IDDM who find regular injections uncomfortable.
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| 7. |
- Hanås, Ragnar
(författare)
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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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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)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. |
- Hanås, Ragnar, et al.
(författare)
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Thinner needles do not influence injection pain, insulin leakage or bleeding in children and adolescents with type 1 diabetes
- 2000
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Ingår i: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X .- 1399-5448. ; 1:3, s. 142-149
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To investigate pain, leakage and bleeding when injecting insulin with different diameters of needles.Methods: Sixty children and adolescents aged 9–21 yrs participated in study A and 40 aged 8–20 yrs in study B. Both were double-blind and randomized. In study A, we evaluated the pain when injecting with three needles [Novo 27G/13 mm (N27), B-D MicroFine IV 28G/13 mm (B28), NovoFine 28G/12 mm (N28)] and in study B, with three needles [NovoFine 28G/12 mm (N28), B-D MicroFine+ 29G/13 mm (B29), NovoFine 30G/8 mm (N30)] and one placebo injection (no needle mounted). Abdominal and thigh injections were given in a 45° angle with a lifted two-finger skinfold on two different visits, scoring pain on a 10-cm visual analog scale (VAS), and in study B faces were added to the scale.Results: The median VAS scores in study A were 1.2 cm (N27), 1.2 cm (B28) and 1.0 cm (N28) for abdominal injections, and 1.2 cm (N27), 0.7 cm (B28) and 1.1 cm (N28) (n.s.) for thigh injections. The median VAS scores in study B were 2.5 cm (N28), 2.3 cm (B29) and 2.8 cm (N30) (n.s.) for abdominal injections, and 2.0 cm (N28), 1.5 cm (B29) and 1.9 cm (N30) (n.s.) for thigh injections. The overall median score of placebo injections was 0.1 cm (p=0.0001). Bleedings were less common with the B29 needle (35.5%) than with the N28 needle (48.1%) (p=0.028) but with no difference compared to the N30 needle (39.2%). 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 study B which may be explained by the facial VAS scale increasing the range of answers.Conclusions: We found no difference in injection pain, preference, bleeding or insulin leakage between the needles. Decreasing the needle diameter from 0.4 to 0.3 mm (27–30G) does not seem to decrease pain perception in this age group.
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| 9. |
- Hanås, Ragnar, et al.
(författare)
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Unchanged Insulin Absorption After 4 Days' Use of Subcutaneous Indwelling Catheters for Insulin Injections
- 1997
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Ingår i: Diabetes Care. - : American Diabetes Association. - 0149-5992 .- 1935-5548. ; 20:4, s. 487-490
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE Since 1985, we have used indwelling catheters (Insuflon, Maersk Medical, Lynge, Denmark; Chronimed, Minnetonka, MN) to lessen pain when injecting insulin. However, some patients experience a rise in blood glucose after using indwelling catheters for a few days. We therefore studied the absorption of 125I-labeled insulin when using indwelling catheters.RESEARCH DESIGN AND METHODS Five men and five women participated (age 18–25 years, C-peptide negative, HbA1c 9.0 ± 1.0% [mean ± SD, DCA-2000 method], diabetes duration 5–21 [median 9.5] years). After thyroid blockage with potassium iodide, we injected 5IU of 125I-labeled short-acting insulin subcutaneously in the abdomen (“ordinary injection”) and 5 IU on the contralateral side through an indwelling catheter (“catheter injection”). The injection/insertion area was free of lipohyper- and lipohypotrophies. Disappearance rate was measured for 180 min with a gamma camera. The patients injected all premeal injections of short-acting insulin through the same indwelling catheter in the following 4 days. The investigation procedure was repeated day 3 and 5.RESULTS We found no statistically or clinically (95% CI) significant difference in residual activity of 125I-insulin after 60 min or in time for 50% of the injected depot to disappear (T-50%) among catheter injections on day 1, 3, and 5; ordinary injections on days 1, 3, and 5; or catheter and ordinary injections on days 1, 3, and 5, respectively. HbA1c correlated both to T-50% (r = 0.73, P = 0.016) and residual activity of 125I-insulin after 60 min (r = 0.69, P = 0.028), indicating that patients with a slower absorption will have a less ideal metabolic control when using premeal bolus injections.CONCLUSIONS We conclude that using indwelling subcutaneous catheters for insulin injections for up to 4 days does not affect the absorption of short-acting insulin.
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| 10. |
- Ludvigsson, Johnny, et al.
(författare)
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Combined Etanercept, GAD-alum and vitamin D treatment: an open pilot trial to preserve beta cell function in recent onset type 1 diabetes
- 2021
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Ingår i: Diabetes-Metabolism Research and Reviews. - : Wiley. - 1520-7552 .- 1520-7560.
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Tidskriftsartikel (refereegranskat)abstract
- Aim We aimed to study the feasibility and tolerability of a combination therapy consisting of glutamic acid decarboxylase (GAD-alum), Etanercept and vitamin D in children and adolescents with newly diagnosed with type 1 diabetes (T1D), and evaluate preservation of beta cell function. Material and Methods Etanercept Diamyd Combination Regimen is an open-labelled multi-centre study pilot trial which enrolled 20 GAD antibodies positive T1D patients (7 girls and 13 boys), aged (mean +/- SD): 12.4 +/- 2.3 (8.3-16.1) years, with a diabetes duration of 81.4 +/- 22.1 days. Baseline fasting C-peptide was 0.24 +/- 0.1 (0.10-0.35) nmol/l. The patients received Day 1-450 Vitamin D (Calciferol) 2000 U/d per os, Etanercept sc Day 1-90 0.8 mg/kg once a week and GAD-alum sc injections (20 mu g, Diamyd (TM)) Day 30 and 60. They were followed for 30 months. Results No treatment related serious adverse events were observed. After 6 months 90-min stimulated C-peptide had improved in 8/20 patients and C-peptide area under the curve (AUC) after Mixed Meal Tolerance Test in 5 patients, but declined thereafter, while HbA1c and insulin requirement remained close to baseline. Administration of Etanercept did not reduce tumour necrosis factor (TNF) spontaneous secretion from peripheral blood mononuclear cells, but rather GAD65-induced TNF-alpha increased. Spontaneous interleukin-17a secretion increased after the administration of Etanercept, and GAD65-induced cytokines and chemokines were also enhanced following 1 month of Etanercept administration. Conclusions Combination therapy with parallel treatment with GAD-alum, Etanercept and vitamin D in children and adolescents with type 1 diabetes was feasible and tolerable but had no beneficial effects on the autoimmune process or beta cell function.
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