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[IP] under 10...they don't NEED the pump! VERY LONG

Re: Shands hospital in N. Florida he're my response to the endo who responded 
to me., after his nurse received my response to her.....it's almost all in 
:In a message dated 8/23/99 10:26:49 AM EST, email @ redacted writes:

>  almost all my 
>  patients under 10 years, who would be pump candidates however, their 
>  HbA1cs are excellent, families FAX or EMAIL their readings to me/us on a 
>  regular basis, count carbs, and do not need the pump. 

I strenuously disagree with your statement that these patients do not need 
the pump, Dr. Schatz.  I don't think you have an accurate idea of what it is 
to LIVE day in and day out, 24 hours a day, 7 days a week, feeding insulin 
that is on board, and telling a child not to eat when they are hungry because 
it is not time to eat according to the insulin in their body.  I respectfully 
request that you revisit this archaic way of thinking.

Firstly, I do not advocate that every child should be on the pump.  It is 
certainly a personal decision.  Secondly I do not feel that every family is 
capable nor financially able to have their child on the pump.   Thirdly, 
there is no doubt that near non-diabetes A1C's can be achieved with multiple 
daily injection therapy, but at what price?  Every time the child wants an 
impromptu snack after school that hasn't been accounted for, that same child 
has to negotiate with him/herself for yet another injection? Is that a way to 
live as a child?

The insulin pump gives a child back the freedom to be a child and not a slave 
to the clock.  The freedom to wake up late on Saturday morning and not have 
to eat breakfast until (s)he is ready to eat, or to go out to brunch as a 
family , or to go and enjoy a nightime Bar Mitzvah party where dinner isn't 
served until 9:00 p.m. or later.  This is what life is , not following a 
rigid schedule and a rigid meal plan where carbs have to be consumed because 
there is long acting insulin on board that must be fed at certain precise 
times of the day.  I really feel you do not have a realistic picture of what 
it is to parent or to be a child with diabetes 24/7 when you make a statement 
that a child under 10 doesn't need a pump.  Have you ever conversed with Dr. 
_____ on this subject?  Or with the other pediatric endocrinologists across 
this country who do see the benefits of CSII over MDI and prescribe it 
readily with a great deal of success?  It surprises me that it's easier to 
get a child on the pump in the middle of Utah, than at Shands in N. Florida.  
I urge you to revisit your philosophy on young children pumping.  You really 
don't know what you are depriving these children of - a modicum of normalcy 
in their lives!

Ellen H. Ullman

From:   email @ redacted (Des Schatz of ENDO)
To: email @ redacted
CC: email @ redacted, email @ redacted (Martha McCallum)

Martha sent this on to me and I think the wording has been taken a 
little out of context.  We have several kids on pumps. I am fully aware 
of those data you sent. In my opinion, CSII IS  a viable alternative and 
can be used for the right child, the right family, under the right 
circumstances.  Those criteria Martha set out re CHO counting, ability to 
check BG regularly and act accordingly are important. In almost all my 
patients under 10 years, who would be pump candidates however, their 
HbA1cs are excellent, families FAX or EMAIL their readings to me/us on a 
regular basis, count carbs, and do not need the pump. However 
we do prescribe the pump as an alternative, or if there is frequent 
hypolycemia on multiple insulin shots

Desmond Schatz MD
Professor of Pediatrics
Medical Director, Diabetes Center

> In a message dated 8/23/99 9:29:26 AM EST, email @ redacted writes:
> > We do not put "young children" on CSII and as a matter of fact have a 
> > strict criteria for even the teenagers/young adults who want pumps. They 
> must 
> > perform intensive therapy with testing , multiple daily injections, and 
> carb 
> > count for 3-6 months before we consider putting them on .
> This is exceedingly disappointing, coming from what is supposedly a cutting 
> edge institution.  How do you justify this decision when thousands of 
> children are successfully pumping and living a much more normal existance 
> restricted by the constraints of the clock and peaking long acting insulin 
> which forces them to eat all day long whether or not they are hungry?  I 
> you to revisit this decision.     It's time that Shands starts practicing 
> 20th century medicine before the 21st century hits, where diabetes 
> is concerned.  Stuart Brink MD, put my friend's now 18 year old daughter on 
> the pump 15 years ago, when her daughter was 3 years old.  She's doing 
> beautifully still today on the pump.  I thank G-d that my son has a 
> and brilliant diabetologist/pediatric endocrinologist in south Florida, Dr. 
> _________, who offered my son the pump at age 7.  My son has been 
> successfully pumping for over 4 years.  I shudder to think what an awful 
> existence he would have had I entrusted his care to your backward way of 
> thinking institution on this issue.  Below you will find  abstracts, some 
> which are quite old, which prove that CSII is a viable  alternative to 
> injection therapy for children. 
> 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
>  <A 
> HREF="http://www.childrenwithdiabetes.com/download/hanas_pump.pdf">children 
> with DIABETES - Books for Parents, A... 
> 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  
> ---------------------------------------------------------
> 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 hypoglycemia 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 
> ---------------------------------------
> 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 
> ----------------------------------------
> 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 
> ----------------------------------------------------------------------
> 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).
> -----------------------------
>  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 
>  ----------------------------------------------------------
> 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: 
> 6.9 +/- 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 
> one 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)
> -------------------------------------------------------
> 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 
> 4 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.
> ---------------------------------------------
> 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.
> Regards,
> Ellen H. Ullman
> Mom, Advocate for children with diabetes and their parents, Friend, 
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