[Previous Months][Date Index][Thread Index][Join - Register][Login]
[Message Prev][Message Next][Thread Prev][Thread Next]

RE: [IPk] re pump propaganda: References (longish)



Hi Abigail

These are a few references that I came across. These are abstracts from
presentations at the EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES (EASD)
conference two weeks ago. Mostly positive about pumps. I'd be interested to
see your letter.

I've sent this to the list because others may be interested.

I think there is a page on the DbUk site about pump research which states
that no major trials of the advantages/disadvantages of pumps have been
done. WHY NOT?. I don't have the detailed reference to hand.

Rgds

Julian

Summary:

* PUMP vs MDI FOR CHILDREN
* PEN vs PUMP FOR TYPE IIs
* Insulin pump therapy versus multiple daily injections in obese type 2
diabetic patients
* Remission patterns after short-term continuous subcutaneous insulin
infusion therapy in Korean type 2 diabetic patients.
* Continuous Infusion of Exendin-4 Lowered HbA1c at Least as Effectively as
Twice Daily Injections in Diabetic Fatty Zucker (ZDF) Rats.
* FIRST IMPLANTATIONS OF A LONG TERM GLUCOSE SENSOR CONNECTED TO INSULIN
PUMPS IN DIABETIC HUMANS

--------------------------------------------------
Julian title: PUMP vs MDI FOR CHILDREN
Abstract: 95

Continuous Subcutaneous Insulin Infusion versus Multiple Daily Injections in
Children with Type 1 Diabetes

N. Weintrob, H. Benzaquen, S. Shalitin, G. Fayman, A. Galatzer, Z.
Dickerman, P. Moshe

Background and Aims: To compare the efficacy and feasibility of continuous
subcutaneous insulin infusion (CSII) and multiple daily insulin injections
(MDI) in children with type 1 diabetes.

Materials and Methods: The study sample included 13 children (6 males) aged
9.4 to 13.3 years with c-peptide-negative type 1 diabetes. Duration of
disease was 2.8 to 11 years. An open randomized crossover design was used to
compare 3.5 months of CSII to 3.5 months of MDI therapy for the following
variables: diabetic control, incidence of symptomatic hypoglycemia and
hyperglycemia, ketonuria, daily insulin requirement, diabetic ketoacidosis
(DKA), body mass index standard deviation scores (BMI SDS) and safety. All
comparisons were analyzed by ANOVA with repeated measures. 

Results: HbA1c values at the start and end of each treatment arm were
similar (7.85-S>-0.68 and 7.96-S>-0.66 for the pump phase, 7.92-S>-0.46 and
7.81-S>-0.87 for the MDI phase). There were no differences between the
treatment modes in frequency of mild symptomatic hypoglycemic or
hyperglycemic events, both diurnal and nocturnal. There was one event of
severe nocturnal hypoglycemia without coma in the MDI phase. Ketonuria
tended to be more frequent during the pump therapy period (p=0.06), but
there was no DKA. There was no significant change in BMI SDS during the
entire study. Mean insulin dose at the end of the pump phase was lower than
at the end of the MDI phase (0.89-S>-0.14 and 1.09-S>-0.21 u/kg/day,
respectively, p<0.01). At the end of the study, 10/13 patients chose to
continue pump therapy. 

Conclusions: Diabetic control is similar in children treated with the
insulin pump or with MDI, and it is comparable to that achieved in the
Diabetes Control and Complications Trial (DCCT) by the intensive adolescent
group. This study suggests that intensive insulin therapy by either CSII or
MDI can be used safely in children and young adolescents with type 1
diabetes. In our series, most of the children preferred to continue with the
insulin pump.

--------------------------------------------------
Julian title: PEN vs PUMP FOR TYPE IIs

Abstract: 93


PATIENT SATISFACTION WITH INTENSIVE INSULIN THERAPY IN TYPE 2 DIABETES: A
RANDOMIZED TRIAL OF INSULIN PEN VS. PUMP

R.R. Turner, M.A. Testa, J.F. Hayes, D.C. Simonson

Harvard University, Boston, MA, USA

Background and Aims: To better understand why intensive insulin therapy for
persons with type 2 diabetes is difficult to initiate and sustain, we
studied 126 insulin-treated type 2 patients randomized to multiple
subcutaneous insulin (pen) injections (PEN; n = 60) or continuous
subcutaneous insulin (pump) infusion (PUMP; n = 66).

Materials and Methods: Patients were 61% male, 73% married, 77% Caucasian,
aged 56 1 9 yrs, and had HbA1c, = 8.1 1 1.2%, FPG = 200 1 65 mg/dL and BMI =
32 1 5 kg/m2. Satisfaction questionnaires were completed at baseline and at
16 and 24 weeks after randomization.

Results: Mean 1 SE overall satisfaction (scaled 0 to 100) from baseline to
endpoint improved more for PUMP (59.4 1 2.1 to 79.2 1 1.8) than for PEN
(63.6 1 1.9 to 70.3 1 2.3), p < 0.0001. Changes 1 SE from baseline to
endpoint for the following satisfaction subscales (0 to 100) similarly
showed more favorable effects for PUMP vs PEN: burden (16.3 1 2.1 vs 5.2 1
2.2), convenience (21.2 1 2.7 vs 5.5 1 2.4), efficacy (31.1 1 3.0 vs 14.1 1
3.3), flexibility (23.0 1 2.7 vs 6.3 1 2.4), general satisfaction (28.1 1
3.0 vs 10.2 1 3.6), and life interference (23.0 1 2.8 vs 5.1 1 2.6), all p <
0.0001; hassle (16.2 1 2.7 vs 6.3 1 2.8), advocacy (25.6 1 3.4 vs 13.0 1
3.9), preference (31.8 1 4.2 vs 11.2 1 4.6), and social limitations (5.2 1
1.7 vs -1.0 1 1.7), all p < 0.02. Mean decrease 1 SE in endpoint FPG was
significantly greater for PUMP vs PEN (-46 1 9 vs -12 1 12 mg/dL; p < 0.02),
but the decrease in HbA1c (-0.62 1 0.14% vs -0.46 1 0.13%) was not. Over 90%
of PUMP patients preferred the pump to their previous injectable regimen on
each of 13 factors including dose adjustment (choosing pump = 97%),
convenience when traveling (97%), ease of use, better glucose control,
flexibility in daily activities and convenience (all 95%), overall
preference and feeling better about themselves (both 93%).

Conclusions: Type 2 patients demonstrated greater satisfaction with the pump
compared to multiple daily injections using the pen. Increasing patient
acceptance may improve compliance and facilitate the initiation and
sustainability of intensive insulin therapy in type 2 diabetes.
--------------------------------------------------
Julian title: Insulin pump therapy versus multiple daily injections in obese
type 2 diabetic patients

Abstract: 94

Insulin pump therapy versus multiple daily injections in obese type 2
diabetic patients.

J. Wainstein1, M. Metzger2, O. Menuchin3, Y. Cohen4, A. Yaffe5, M. Ravid6,
I. Harman7, I. Raz2, For the Israeli Diabetes Research Group

1 Wolfson Hospital, Holon, Israel, 2 Hadassah University Medical Center,
Jerusalem, Israel, 3 Lyn Clinics, Klalit Health Fund, Haifa, Israel, 4
Makabi Health Fund, Rishon LeZion, Israel, 5 Hillel Jaffe Hospital, Hadera,
Israel, 6 Meir Hospital, Kfar Saba, Israel, 7 Soroka Hospital, Beer Sheva,
Israel.

Background and aims: Obese type 2 diabetic patients with severe insulin
resistance tend to develop chronic hyperglycemia despite maximal treatment
with diet, physical exercise and oral hypoglycemic agents. High dose insulin
therapy in these patients does not usually lead to satisfactory glucose
control and causes weight increase, which in turn aggravates insulin
resistance and exacerbates other cardiovascular risk factors. A pilot study
by the Israeli Diabetes Research Group showed that continuous insulin
delivery by means of an insulin pump (Minimed 507R) was superior to multiple
daily insulin injections in terms of glucose control, weight gain and total
daily insulin requirement. 

Material and methods: 39 obese (BMI > 30) type 2 diabetic patients, not
controlled (HbA1C > 8.5%) on high dose insulin therapy (daily insulin
requirement superior to 1 unit/kg body weight/day) were randomized to
receive an 18-week insulin pump treatment followed (P-M group) or preceded
(M-P group) by an 18-week multiple injection treatment, with a 12-week
washout period in-between. 

Results: During the first 18 weeks: HbA1C decreased from 10.2 +/- 1.22 %
(mean +/- SD) at week 0 to 8.06 +/- 1.15 % at week 18 in the M-P group (p =
0.001) and from 10.23 +/- 1.43 to 7.65 +/-1.04 in the P-M group (p = 0.001).
Daily insulin requirement decreased from 102 +/- 24 units/day at week 0 to
85 +/- 29 at week 18 (p=0.004) in the P-M group, and increased, though not
significantly, from 113 +/-28 at week 0 to 116 +/- 30 at week 18 in the M-P
group. The absolute number of extreme hyperglycemic capillary blood glucose
values decreased in the P-M group, but not significantly. There was no
significant weight increase in either group. 

Conclusions: We conclude that obese type 2 patients on high dose insulin
therapy can dramatically improve their blood glucose control without gaining
weight either by intensifying the daily multiple injection treatment or by
using an insulin pump, the latter allowing for reduction of daily insulin
requirement. Further results (including continuous subcutaneous glucose
monitoring) are expected to precise the individual benefit of insulin pump
therapy versus multiple daily injections in such patients.

--------------------------------------------------
Julian title: Remission patterns after short-term continuous subcutaneous
insulin infusion therapy in Korean type 2 diabetic patients.

Abstract: 96


Remission patterns after short-term continuous subcutaneous insulin infusion
therapy in Korean type 2 diabetic patients.

S.B. Choi, B.A. Park, E.K. Choi, S. Park

Internal Medicine, Konkuk University, Chngjoo-Si and Food and Nutrition,
Hoseo University, Asan-Si, Korea

Background and Aims: Studies have found that chronic hyperglycemia can
deteriorate pancreatic beta cell function and insulin sensitivity, and the
normalization of blood glucose can reverse these functions. The purpose of
the study is to evaluate the normoglycemic remission pattern after a certain
period of continuous subcutaneous insulin infusion (CSII) therapy in Korean
type 2 diabetic patients and to determine the clinical characteristics for
remission. 

Materials and Methods: Ninety-one mild type 2 diabetic patients were treated
by CSII therapy via insulin pump (Sooil, Seoul, Korea) until they did not
need any medication for glycemic control. Follow-up examinations took place
once every month at an outpatient clinic for non-remitted patients and by
phone for remitted patients, and their blood glucose levels and insulin
dosage were monitored for fifteen to seventeen months. 

Results: Overall, in 34.4 % of all subjects, remission was induced after
53.6138.9 days of CSII therapy and lasted for an average of 13.618.9 months
during the study periods. Blood glucose levels continuously decreased to be
normalized at 7.311.2 days with maximum dosage of daily total insulin after
CSII therapy. Total insulin dosage to normalize blood glucose levels
gradually decreased until 14.412.7 days of CSII therapy in all subjects.
Total daily insulin dosage did not significantly decrease any more from
about 14 days of the therapy in non-remitted patients, but it did
continuously decrease and reached at zero in remitted patients. In
correlation analysis, remission was more frequently induced when patients
started CSII therapy in younger age (r=-0.41,p<0.01), with higher body mass
index (r=0.36, p<0.05), shorter diabetic duration (r=-0.48, p<0.01), lower
post-prandial blood glucose levels (r=-0.51, p<0.01), higher post-prandial
serum c-peptide levels (r=0.42, p<0.01), and less chronic diabetic
complications (r=-0.47, p<0.01). 

Conclusions: These findings suggest that long-term CSII therapy can induce
remission in a significant proportion of Korean type 2 diabetic patients
with mild symptoms. Thus, it is desirable that intensive insulin treatment
by CSII be considered as not the last treatment, but an initial management
of mild type 2 diabetic patients.

 
--------------------------------------------------
Julian title: Continuous Infusion of Exendin-4 Lowered HbA1c at Least as
Effectively as Twice Daily Injections in Diabetic Fatty Zucker (ZDF) Rats.

Abstract: 759

Continuous Infusion of Exendin-4 Lowered HbA1c at Least as Effectively as
Twice Daily Injections in Diabetic Fatty Zucker (ZDF) Rats.

S. Bhavsar, C. Jodka, P. Smith, B. Gedulin, A. Young

Amylin Pharmaceuticals Inc, San Diego, CA

Background and Aims: In previously reported studies done in Diabetic Fatty
Zucker (ZDF) rats, daily peripheral injections of synthetic exendin-4
(AC2993) lowered hemoglobin A1c (HbA1c). In rats, HbA1c is a useful index of
blood glucose averaged over ~4 weeks. Some hormones are only fully effective
if delivered in a pulsatile manner. The purpose of the present study was to
compare the effect on HbA1c of continuous infusion of exendin-4 versus the
same dose delivered by twice daily injection, and thus determine if
continuously present exendin-4 was associated with a diminished glycemic
effect. 

Materials and Methods: Three groups of animals (n=5/group) were each
implanted with Alza pumps (delivering 605L/24 hours) and were injected i.p.
twice daily (305L/injection). Control animals (CONT) received vehicle by
pump and i.p. injection; continuous infusion (INF) animals received
exendin-4 via Alza pumps (185g/605L/24 hours) and vehicle via twice daily
i.p. injections; the pulsatile injection (INJ) group received the same dose
via two 95g/305L/injections each day for 28 days. HbA1c was measured weekly.


Results: Entry HbA1c of the 3 treament groups were indistinguishable (range
9.30-9.38%; n.s.). After 28 days of treatment, HbA1c had fallen from
9.3210.46 to 8.7010.33% in CONT (n.s.), from 9.3010.37 to 7.7410.63 in INJ
(P=0.07), and from 9.3810.41 to 5.6410.76% in INF (P=0.003). Thus, after 28
days of treatment, the mean decrement in HbA1c of the INF group (3.7410.48)
was greater than that of the INJ group (1.5610.93, P=0.07). 

Conclusions: Continuous infusion of exendin-4 was effective in lowering
HbA1c in ZDF rats, and this effect was at least as great as that of the same
dose given as a twice-daily injection. Thus, in this experimental model of
type 2 diabetes, hormonal action of exendin-4 was not diminished by its
continual presence.

 
--------------------------------------------------
Julian title: FIRST IMPLANTATIONS OF A LONG TERM GLUCOSE SENSOR CONNECTED TO
INSULIN PUMPS IN DIABETIC HUMANS

Abstract: 169

FIRST IMPLANTATIONS OF A LONG TERM GLUCOSE SENSOR CONNECTED TO INSULIN PUMPS
IN DIABETIC HUMANS

E. Renard1, L. Jovanovic2, G. Costalat1, N. Rikalo2, K. Waxman2, M. Kolopp3,
R. Shah3, J. Bringer1

1 Lapeyronie Hospital, Montpellier, France

2 Sansum Medical Research Inst./Cottage Hospital, Santa Barbara, CA; 3
Medical Research Group/MiniMed Inc., Sylmar and Northridge, CA, USA

Background and Aims: Implanted insulin pumps have been used in diabetic
subjects for more than 10 years. Connecting an intra-vascular (IV) glucose
sensor to the pump would provide real-time data to enable regulation of
insulin delivery, leading to a true 'artificial beta-cell'. The aim of the
study is to assess the safety and accuracy of an implanted sensor/pump
system.

Methods: Long term glucose sensor systems (LTSS, Medical Research Group and
MiniMed Inc., CA, USA), consisting of an IV glucose sensor connected to a
pump for intra-peritoneal (IP) insulin delivery, were surgically implanted
into ten type 1 diabetic subjects for approximately 18 patient-months.
Sensors were placed through subclavian or internal jugular veins, with
sensor tips in the superior vena cava or right atrium. Sensor data were
compared to six daily capillary blood glucose sample readings on HemoCue
photometers (HemoCue AB, Sweden).

Results: Surgical complications consisted of placing and maintaining the
sensor tip in the proper location. Optimization of the surgical procedure
and modification of the connecting cable facilitated attachment and
prevention of migration. A total of 3788 paired points yields a Mean
Absolute Difference (MAD) of 19.5% over the range of 1.5 to 21.5 mmol/l, a
correlation coefficient (r) = 0.90, and 97% of paired points within the A &
B ranges of the Clarke Grid. These data were sustained after 5 months of
implant.

Conclusions: Our data suggest that the LTSS can perform to sufficient
clinical accuracy over an extended period of time to control IP insulin
delivery.
--------------------------------------------------
> -----Original Message-----
> From: Abigail King [mailto:email @ redacted]
> Sent: 24 September 2001 10:34
> To: email @ redacted
> Subject: [IPk] re pump propaganda
> 
> 
> John
> I've got plans to write but must gather facts, references 
> etc. I've noted
> some references and will get these from the library. Frankly 
> I'm furious
> that this g.t has harmed pump reputation due to one mishap 
> that could have
> been avoided and if I don't clear my head I'm going to write 
> something that
> will be unpublishable. As it is I would like to make some 
> cutting remarks
> about accountability to patients, early deaths due to poor 
> glycaemic control
> and lives debilitated due to hypoglycaemia. I feel that he 
> was arguing on
> the grounds of responsiblity ie laziness, not wanting to 
> update knowledge.
> In some ways I think DM must be one of the worse conditions 
> to have due to
> a) the alleged controllability of the disease vs b) the 
> inevitability of
> problems. ie physicians can use arguments either way to 
> support themselves
> and fob off patients, so that a death resulting on a therapy 
> they can't
> really be bothered with is due to the inherent dangerousness of that
> treatment whereas any problems related to conventional 
> treatments are a)
> either the patients fault or b) the inherent problems arising from dm
> The responsibility argument: I'm sure people reluctant to 
> allow pumps use
> that one. The truth is that the care available to most 
> diabetics shows a
> complete abdication of any responsibilty. I feel that doctors 
> and patients
> often collude together in denial rather than really try to 
> work out the
> problems and when patients do want to take responsibility for 
> themselves
> they face this ridiculous argument of doctor not wanting to 
> be responsible
> if things go wrong. Well they don't seem to be responsible 
> anyway. They
> don't have to live with the disease and it's consequences and 
> in these more
> enlightended days of patient choice and autonomy, hopefully 
> they're not
> going to continue to use that one
> I want to put something at the end of the letter about 
> outdated attitudes
> and infer that perhaps it's time for this guy to retire. I also wonder
> whether results of more recent trials would be of use.
> After all this anger I'm afraid that the stress may have 
> pushed me into DKA
> so I'm going to have to check my BG and may have to make some 
> adjustments to
> my " death machine"
> ----------------------------------------------------------
> for HELP or to subscribe/unsubscribe, contact: 
> HELP@insulin-pumpers.org
> help SUPPORT Insulin Pumpers 
http://www.insulin-pumpers.org/donate.shtml
----------------------------------------------------------
for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
help SUPPORT Insulin Pumpers http://www.insulin-pumpers.org/donate.shtml
----------------------------------------------------------
for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
help SUPPORT Insulin Pumpers http://www.insulin-pumpers.org/donate.shtml