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Insulin Pump - chapter from R. Hanas' book Insulin-Dependent Diabetes in Children, Adolescents and Adults, 1999 (PDF http://www.childrenwithdiabetes.com/download/hanas_pump.pdf
Primary care article on insulin pump therapy from Clinical Diabetes posted at The Islet Foundation message board.
ABSTRACTS:
1 : Diabetes Care 1999 Nov;22(11):1779-84
Continuous subcutaneous insulin infusion. A new way to lower risk of severe hypoglycemia, improve metabolic control, and enhance coping in adolescents with type 1 diabetes.
Boland EA, Grey M, Oesterle A, Fredrickson L, Tamborlane WV
Yale Children's Clinical Research Center, Yale University School of Nursing, New Haven, Connecticut, USA. elizabeth.boland@yale.edu
[Medline record in process]
OBJECTIVE: Recommendations from the Diabetes Control and Complications Trial (DCCT) indicate that adolescents with type 1 diabetes should be treated with intensive therapy involving multiple daily injections (MDI) of insulin or insulin pump therapy (continuous subcutaneous insulin infusion [CSII] to help obtain better metabolic control and prevent later complications. Interest has thus focused on insulin pump therapy to help adolescents meet this challenge. The purpose of this study was to examine responses to CSII and MDI in a large group of adolescents with established type 1 diabetes during a 12-month period and to determine whether either treatment regimen more favorably affected clinical and psychosocial outcomes. RESEARCH DESIGN AND METHODS: One-third of 75 youths aged 12-20 years who were candidates for intensive therapy chose CSII as their mode of treatment. Patients received intensive treatment and education as described by the DCCT investigators. Psychosocial data (e.g., quality of life, depression, self-efficacy, and coping) were collected at baseline and at 6-month intervals, and clinical data (e.g., HbA1c levels, adverse events) were collected every 4-6 weeks. RESULTS: Although both MDI- and CSII-treated adolescents initially exhibited improved metabolic control, this level of control was more difficult to sustain for 12 months in the MDI group (at 6 months HbA1c = 8.1, at 12 months HbA1c = 8.3), whereas average HbA1c levels in the CSII group continued to decrease during the 12 months of treatment (at 6 months HbA1c = 7.7, at 12 months HbA1c = 7.5). Despite lower HbA1c levels in CSII-versus MDI-treated patients, the rate of severe hypoglycemic events was reduced by almost 50% in the CSII group (P = 0.01). Self-reported questionnaires demonstrated that there was improvement in self-efficacy, depression, and quality of life in both MDI- and CSII-treated patients. Finally, adolescents using CSII found coping with diabetes to be less difficult than adolescents using MDI did. CONCLUSIONS: CSII is an alternative means to lower HbA1c levels and reduce the risk of hypoglycemia without adversely affecting psychosocial outcomes in adolescents with type 1 diabetes. PMID: 10546007, UI: 20013330 -------------------------------------------------------
Diabetes Educ 1998 Jan-Feb;24(1):78-86; quiz 87, 89
A primer on the use of insulin pumps in adolescents.
Boland E, Ahern J, Grey M
Yale University School of Nursing, New Haven CT 06536-0740, USA.
Optimal metabolic control to minimize long-term complications is a major treatment goal for adolescents with diabetes mellitus. Reaching this goal is extremely challenging in this population due to unique physiological changes and psychosocial variables that affect metabolic control. Continuous subcutaneous insulin infusion (CSII) may be an excellent treatment alternative for selected adolescents to help overcome some of these challenges. CSII allows for minute insulin changes at variable times throughout the day, providing greater lifestyle flexibility. The purpose of this paper is to review the use of insulin pump therapy in adolescents. Specific strategies regarding screening, initiation, and maintenance of this therapy are described, and case examples are used for illustration. Implications for nursing practice and diabetes education are discussed.
PMID: 9526329, UI: 98187077
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Diabetes Educ 1997 Jan-Feb;23(1):52-4
Use of continuous subcutaneous insulin infusion in young adolescents with diabetes mellitus: a case study.
Boland EA, Ahern J
Yale University Pediatric Diabetes Program, Yale School of Nursing, New Haven, CT 06536-0740, USA.
Continuous subcutaneous insulin infusion (CSII) was initiated in a young female adolescent with severe insulin resistance, decreased growth velocity, and poor metabolic control. The patient's insulin dose had been 3 u/kg/day, and it was hypothesized that her insulin requirements would be much less when only regular insulin was used. Because of the potential risk of severe ypoglycemia from giving regular insulin in amounts equivalent to her injection total daily dose as a constant subcutaneous infusion, the patient was hospitalized to begin pump therapy. Hourly glucose levels were collected for 24 hours to determine insulin requirements with this therapy. The patient subsequently required a significantly reduced dose of insulin (1.2 u/kg/day) with CSII, and her growth velocity improved. Metabolic control based on glycosylated hemoglobin levels also improved. Insulin pump treatment proved to be a viable solution for this young adolescent who required large doses of insulin to maintain reasonable control. Challenges of using this type of therapy in young patients are discussed.
PMID: 9052055, UI: 97204543
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Diabete Metab 1990 Jul-Aug;16(4):273-7
Psychological impact of continuous subcutaneous insulin infusion pump therapy in non-selected newly diagnosed insulin dependent (type 1) Diabetic children: evaluation after two years of therapy.
Slijper FM, De Beaufort CE, Bruining GJ, De Visser JJ, Aarsen RS, Kicken DA, Van Strik R
Department of Child Psychiatry, Erasmus University Rotterdam, The Netherlands.
Thirty type 1 (insulin dependent) diabetic children were treated from diagnosis onwards in a random order (using a table of random permutations) with either continuous subcutaneous insulin infusion pump therapy (CSII), or with conventional injection therapy (CT). After two years of therapy psychosocial measurements were obtained of fifteen CSII children (8 boys, 7 girls; mean age: 12+/-4 years) and thirteen CT children (6 boys, 7 girls; mean age: 10+/-4 years) and their parents. Two families of the CT group refused to participate. The examination consisted of six tests (for the children: junior dutch personality test, WISC-R intelligence test, family relation test, diabetes questionnaire; for the parents: family interaction scale and assessment of acceptance scale). Parents (and pediatricians) rated CSII children higher on compliance and better on metabolic control. Acceptance of diabetes, physical and psychological condition was rated equally by parents and doctors. Except for the diabetes questionnaire, the children of the two groups scored not significantly different. The CSII group expressed significantly less physical complaints and physical restrictions. CSII children showed a tendency to score higher on recalcitrance compared with CT children. How adequate this coping of CSII children may be, is discussed.
Publication Types:
•Clinical trial •Randomized controlled trial
PMID: 2265733, UI: 91092464
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Diabet Med 1989 Dec;6(9):766-71
Continuous subcutaneous insulin infusion (CSII) versus conventional injection therapy in newly diagnosed diabetic children: two-year follow-up of a randomized, prospective trial.de Beaufort CE, Houtzagers CM, Bruining GJ, Aarsen RS, den Boer NC, Grose WF, van Strik R, de Visser JJ
Department of Paediatrics, Erasmus University, Rotterdam, The Netherlands.
The effect of continuous subcutaneous insulin infusion (CSII), begun at diagnosis, on blood glucose control and endogenous insulin production was studied in a group of consecutively referred newly diagnosed diabetic children. In a random order, 15 children started CSII (age 9.5 +/- 4.2 (+/- SD) years) and 15 conventional injection therapy (age 7.0 +/- 3.6 years). For 2 years HbA1 and urinary C-peptide were measured monthly, C-peptide responses to glucagon 6-monthly, and insulin antibodies every 3 months. None of the patients requested change of therapy during the study period, but at 28 months 1 adolescent girl changed to injection therapy from CSII. Severe hypoglycaemia was observed once in each group, but ketoacidosis only once, in the injection therapy group. From 2 months after diagnosis onwards the CSII group had significantly lower HbA1 levels. Urinary and plasma C-peptide levels did not differ between the two groups and similar insulin doses were used throughout the study. At the end of the 2 years of therapy, the CSII group had significantly lower insulin antibody levels. The observations suggest that CSII is well accepted in newly diagnosed children and improves metabolic control, but does not prolong endogenous insulin production.
Publication Types:
•Clinical trial •Randomized controlled trial
PMID: 2533034, UI: 90125531
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Glucose counterregulation in pre-school-age diabetic children with recurrent hypoglycemia during conventional treatment.Brambilla P, Bougneres PF, Santiago JV, Chaussain JL, Pouplard A, Castano L
Diabetes 1987 Mar 36:3 300-4
Abstract
To determine whether immature or defective glucose counterregulation was responsible for the severe recurrent hypoglycemic episodes (3.6 per patient per year) observed during conventional therapy (CT) in six pre-school-age diabetic children, we investigated their metabolic and hormonal responses to insulin infusion (40 mU/kg i.v. for 60 min). Counterregulation was considered adequate because no patient experienced symptoms requiring discontinuation of the test, and blood glucose (BG) nadirs averaged 42 +/- 5 mg/dl. Glucose production rate decreased from 4.2 +/- 0.2 to 2.6 +/- 0.6 mg X kg-1 X min-1. Blood 3-hydroxybutyrate levels were elevated (approximately 3 mM) and did not change during insulin infusion. The responses of epinephrine (from 137 +/- 37 to 393 +/- 143 pg/ml), norepinephrine (from 145 +/- 33 to 347 +/- 152 pg/ml), and growth hormone (from 6.0 +/- 1.5 to 20.3 +/- 5.1 ng/ml) were normal for this age group. As previously observed in diabetic adults, glucagon response was deficient (from 117 +/- 30 to 114 +/- 18 pg/ml). The six children were subsequently treated with continuous subcutaneous insulin infusion (CSII), which resulted in a 20-fold decrease in the number of severe hypoglycemic reactions. Predisposition to severe hypoglycemia in this subset of diabetic children, which remains a refractory problem even after considerable efforts have been made to decrease them, may thus be sharply decreased with CSII therapy. During this therapy, a significant inverse correlation appeared between the individual frequency of BG values less than 40 mg/dl and BG nadir during the insulin infusion test (r = .94, P less than .001).
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Psychother Psychosom Med Psychol 1997 Jul;47(7):249-54
[Quality of life with intensive insulin therapy: a prospective comparison of insulin pen and pump]. [Article in German]
Schiffers T
Diabetesambulanz, Heinrich-Heine-Universitat Dusseldorf.
The purpose of the following-study was to identify aspects of quality of life that are particularly affected by the mode of insulin therapy. 55 patients with insulin-dependent diabetes mellitus, who volunteered for a change of their intensive insulin therapy with pen injections to continuous subcutaneous insulin infusion (CSII) were studied 1 month before, and 6 months after, changing to CSII. The DCCT questionnaire was applied, measuring quality of life in the 4 subscales: satisfaction, impact, social/vocational worries, and diabetes related worries, respectively. The results demonstrate that the "satisfaction" subscale was scored significantly higher (p < 0.02), and the "impact" subscale was scored lower (p < 0.02) with CSII therapy.
Single items showed that this was due to greater flexibility with leisure-time activities and with diet, and to significantly less problems with hypoglycaemia. The subscales "social/vocational worries" and "diabetes-related worries" were scored unchanged, HbA1c changed only slightly from 7.5% (SD 1.2) to 6.9% (SD 0.9): (p < 0.05). It is concluded that disease-related deficiencies in quality of life (satisfaction, impact) improve considerably in insulin-dependent diabetic patients after changing voluntarily from intensive insulin therapy with pen injections to continuous subcutaneous insulin infusion.
PMID: 9333836, UI: 97410651
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Diabetes Care 1999 May;22(5):784-8
Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. German Humalog-CSII Study Group.
Renner R, Pfutzner A, Trautmann M, Harzer O, Sauter K, Landgraf R
3rd Medical Department, Hospital Munchen-Bogenhausen, Germany.
OBJECTIVE: Insulin lispro is an analog of human insulin with a faster onset and a shorter duration of action than regular human insulin. Efficacy and tolerability of insulin lispro in continuous subcutaneous insulin infusion (CSII) treatment were assessed in an open randomized crossover trial comparing insulin lispro and regular human insulin, both applied with insulin pumps. RESEARCH DESIGN AND METHODS: A total of 113 type 1 patients (60 male, 53 female, age [mean +/- SD] 37 +/- 12 years, duration of diabetes 19 +/- 9 years) participated in this open, randomized crossover study. Both insulins were applied for 4 months each with the appropriate intervals between the prandial insulin bolus and the meal (human insulin: 30 min; lispro: 0 min). Observation parameters were HbA1c, daily and postprandial blood glucose profiles, adverse events, rate of hypoglycemic and hyperglycemic events, number of catheter obstructions, and treatment satisfaction as assessed with an international validated questionnaire. RESULTS: The patients were well controlled with a mean HBA1c of 7.24 +/- 1.0% at baseline. HbA1c decreased in both treatment periods, but it was better during insulin lispro treatment (insulin lispro: 6.8 +/- 0.9%, regular human insulin: .9 +/- 1.0%, Friedman's rank-sum test: P < 0.02). In addition, the 1-h and 2-h postprandial rises in blood glucose were significantly lower (P < 0.001 for each meal) with insulin lispro, resulting in smoother daily glucose profiles as compared with regular human insulin. No significant differences were reported for the rate of hypoglycemia (mean +/- SD [median]: insulin lispro 12.4 +/- 13.9 [8], regular human insulin 11.0 +/- 11.2 [8]), for the rate of catheter obstructions (42 events in each treatment arm), and for the number and type of adverse events. No severe case of ketoacidosis was seen during insulin lispro treatment, whereas ne case was reported during therapy with regular human insulin. Treatment satisfaction was better when patients were treated with insulin lispro. CONCLUSIONS: Insulin lispro is a suitable and very convenient pump insulin that may result in an improvement of long-term glucose control during CSII treatment. Its safety profile does not differ from that of regular human insulin.
PMID: 10332682, UI: 99265086 -------------------------------------------------------------------
Continuous subcutaneous insulin infusion (CSII) in children and adolescents with chronic poorly controlled type 1 diabetes mellitus.Steindel BS, Roe TR, Costin G, Carlson M, Kaufman FR
Diabetes Res Clin Pract 1995 Mar 27:3 199-204
Abstract
This study was undertaken to determine if continuous subcutaneous insulin infusion (CSII) could improve control, diminish episodes of diabetic ketoacidosis (DKA), decrease number of hospitalizations and save health care expenditure in children and adolescents with long-standing poorly controlled diabetes mellitus. A retrospective analysis was done of six patients with type 1 diabetes for 1-8 years, of whom 4 were non-adherent to the diabetic regimen (ages 12-16.5 years) and 2 of whom had brittle diabetes (ages 8.5 and 10 years). These patients were non-randomly placed on the MiniMed (Sylmar, CA) CSII system. The year prior to CSII was compared with the year during pump use. Glycoslyated hemoglobin (HbA1c), spot urinary microalbumin, total cholesterol, insulin dose, growth velocity, number of convulsions and hypoglycemic events, number of episodes of DKA, number of hospitalizations and total inpatient costs were compared for the 2 years. The year prior to CSII, mean HbA1c was 9.02% (S.D. = 0.86%), mean number of hospitalizations was 5.2/patient (S.D. = 4.6), mean number of hospital days was 20.8/patient (S.D. = 14.7) and mean cost was $29330/patient (S.D. = $22804). During 1 year of CSII, mean number of hospital days decreased to 5 days/patient (S.D. = 0.8, P = 0.016), mean number of hospitalizations (including DKA and pump initiation) decreased to 1.7/patient (S.D. = 0.7, P = 0.31), mean inpatient costs decreased to $12762/patient (S.D. = $5.950, P = 0.047). HbA1c, urinary microalbumin, cholesterol, insulin dose and growth velocity did not change in a statistically significant manner.(ABSTRACT TRUNCATED AT 250 WORDS)
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Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes.
Bode BW, Steed RD, Davidson PC
Diabetes Care 1996 Apr 19:4 324-7
Abstract
OBJECTIVE: To compare the incidence of severe hypoglycemia in patients
crossed over from multiple daily injections (MDIs) of insulin to
continuous subcutaneous insulin infusion (CSII). RESEARCH DESIGN AND
METHODS: From a population of 225 patients using CSII, all patients who met the following selection criteria were included in the present study: 1) a minimum of 12 months on intensive therapy with MDIs before switching to CSII, and 2) a minimum of 12 months on CSII after crossover. Glycemic control and adverse event rates for the 1-year MDI control period were compared with those for the CSII therapy period.
RESULTS: The incidence of severe hypoglycemia during MDI therapy declined from 138 to 22 events per 100 patient-years during the 1st year of CSII (P < 0.0001) and remained significantly lower in years 2, 3, and on CSII (26, 39, and 36, respectively). HbA1c levels did not change significantly between the MDI phase and any year on CSII. However, in the subgroup of patients who had pre-CSII HbA1c levels of > or = 8.0%, the change to CSII was associated with a significant reduction in HbA1c from baseline to year 1 (8.9 +/- 0.8 vs. 8.1 +/- 1.0%, P = 0.0004). The difference in diabetic ketoacidosis rates between the MDI year (14.6 events per 100 patient-years) and the CSII period (7.2 events per 100 patient-years) was not statistically significant. CONCLUSIONS: CSII therapy was associated with a marked and sustained reduction in the rate of severe hypoglycemia without adversely affecting the level of glycemic control attained during MDI therapy. The more reproducible and flexible insulin delivery afforded by CSII was considered to be the major factor contributing to the improvement in severe hypoglycemia rates.
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Early morning glycaemia and the metabolic consequences of delaying breakfast/morning insulin. A comparison of continuous subcutaneous insulin infusion and multiple injection therapy with human isophane or human ultralente insulin at bedtime in insulin-dependent diabetics.
Haakens K, Hanssen KF, Dahl-Jørgensen K, Vaaler S, Torjesen P, Try K
Scand J Clin Lab Invest 1989 Nov 49:7 653-9
Abstract
We studied morning glycaemia and metabolic consequences of delaying morning insulin/breakfast in insulin-dependent diabetics on (i) continuous subcutaneous insulin infusion (CSII) (n = 27), (ii) multiple-injection therapy (MI) with human isophane insulin at bedtime (MI/human isophane) (n = 23) and (iii) MI with human ultralente insulin at bedtime (MI/human ultralente) (n = 14). After an overnight fast, food and insulin (except for the basal infusion on CSII) were withheld, and blood glucose, serum free insulin and serum betahydroxybutyrate were followed from 0800 hours to 1300 hours. At all times blood glucose was lowest on CSII, intermediate on MI/human isophane and highest on MI/human ultralente; serum free insulin was highest on CSII, intermediate on MI/human ultralente and lowest on MI/human isophane; serum betahydroxybutyrate was lowest on CSII, intermediate on MI/human ultralente and highest on MI/human isophane. Blood glucose rose significantly on MI/human isophane (p less than 0.001) and CSII (p less than 0.02); serum free insulin declined significantly on MI/human isophane (p less than 0.001), and betahydroxybutyrate rose significantly on all regimens. Morning metabolic control is better with CSII than MI. Human isophane insulin is preferable to human ultralente insulin overnight in MI. Delaying morning insulin is not advisable on intensified insulin regimens, being most unfavourable with MI/human isophane.
**These abstracts were taken from pubmed.