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Review of Continuous Subcutaneous Insulin Infusion (Insulin pump) Therapy


Review of Continuous Subcutaneous Insulin Infusion (Insulin pump) Therapy Endocrine Morning Rounds October 8, 2008 Arthur Chung PGY-3 – PowerPoint PPT presentation

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Title: Review of Continuous Subcutaneous Insulin Infusion (Insulin pump) Therapy

Review of Continuous Subcutaneous Insulin
Infusion (Insulin pump) Therapy
  • Endocrine Morning Rounds
  • October 8, 2008
  • Arthur Chung PGY-3

  • Insulin pumps how it works
  • Insulin pumps in Diabetes Mellitus, type 1
  • advantages
  • disadvantages
  • Insulin pumps in Diabetes Mellitus, type 2
  • Insulin pumps in pregnancy
  • Insulin pumps in perioperative care

What is insulin pump therapy?
  • The device includes
  • The pump itself (including controls, processing
    module, and batteries)
  • A disposable reservoir for insulin (inside the
  • A disposable infusion set, including a cannula
    for subcutaneous insertion (under the skin) and a
    tubing system to interface the insulin reservoir
    to the cannula.
  • With pump therapy, basal insulin is supplied in
    the form of a continuous infusion (comprising
    between 40 and 60 percent of the total daily
    dose) with pre-meal bolus doses given to minimize
    postprandial glucose excursions.

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  • Good candidates
  • Patients must monitor their blood glucose at
    least 4 times daily
  • learn to carbohydrate count
  • have a rescue algorithm (eg, a correction
  • be sufficiently motivated
  • have an appropriate support system
  • possess problem-solving skills.
  • Choice of insulin 
  • Only short-acting insulin (regular), or
    rapid-acting insulins are used.
  • A double-blind crossover trial, insulin lispro,
    compared to regular insulin, resulted in greater
    reduction in postprandial blood glucose
    concentrations (by 25 mg/dL 1.4 mmol/L), lower
    A1C (by 0.3 percent), fewer episodes of
    hypoglycemia, and less weight gain (Diabetes 1997
    Mar46(3)440-3). Similar results have been seen
    with insulin aspart (Diabetes Care 2002

  • Getting started 
  • Convert a patient from an MDI regimen to insulin
    pump therapy based on pre-pump level of chronic
    glycemia and total daily dose of insulin.
  • Eg. If previously well controlled with A1C lt7.0
    percent, the initial total daily dose of insulin
    administered by pump may be 10 to 20 percent less
    than the total daily dose of the previous
  • Approximately ½ of total daily dose basal rate.
  • Eg. basal rates are in the range of 0.01 to 0.015
    units per kg per hour (ie, for a 60 kg woman
    approximately 0.6 to 0.9 units per hour). The
    basal rates are adjusted empirically based on
    glucose monitoring results.
  • Infusion rates depending on individual factors
    including life-style and the "dawn phenomenon"
    which often occurs between 2 AM and 8 AM.
  • Most pumps allow for pre-programmed changes in
    basal rate to accommodate these requirements.

Insulin pump therapy in DM 1
  • What are the advantages of insulin pump therapy?
  • 1) Improved glycemic control and less
    hypoglycemic events
  • Numerous trials have been done comparing glycemic
    control and hypoglycemia with CSII vs. MDI.
  • Using an insulin pump eliminates unpredictable
    effects of intermediate- or long-acting insulin.
  • Insulin absorption is less variable from day to
    day. Both the small subcutaneous depot, and the
    constancy of the injection site and depth for the
    two to three days with each catheter, contribute
    to the relative consistency of absorption.

Jeitler et al. 2008. Comparing CSII vs. MDI in
  • Methods A meta-analysis of RCTs up to March
  • 22 trials 17 on type 1 diabetes mellitus (908
    patients), two on type 2 diabetes mellitus (234
    patients), three on children (74 patients).
  • Adult DM I 12 studies were used for the
  • In 6 studies using HbA1c ? -0.4 WMD in favour of
    CSII therapy over MDI.
  • In 6 studies using HbA1 ? - 0.6 WMD (not
    statistically significant)
  • No meta-analysis was performed on hypoglycemic
  • Mild or overall hypoglycemic events were
    comparable between the two groups
  • CSII group 1.9 0.93.1 events per patient per
  • MDI group 1.7 1.13.3 events per patient per
  • No overall conclusions were possible for severe
    hypoglycaemia and adverse events for any of the
    different patient groups due to rareness of such
    events, different definitions and insufficient

Jeitler et al. Diabetologia (2008) 51941951.
Pickup and Sutton 2008 meta-analysis of CSII vs.
  • Reviewed the frequency of severe hypoglycemia in
    CSII vs. MDI
  • Studied more recent trials because of poor
    quality of earlier trials
  • Analyzed the idea that CSII may be more
    beneficial in DMI patients who fail to achieve
    glycemic control on MDI.
  • Method
  • Databases and literature (19962006) were
    searched for randomized controlled trials (RCTs)
    and before/after studies of 6 months duration
    CSII and with severe hypoglycaemia frequency gt 10
    episodes/100 patient years on MDI.
  • Results
  • 22 studies (21 reports). 1414 DMI patients for
    mean CSII duration of 6 28 months.
  • Severe hypoglycaemia during MDI was related to
    diabetes duration (P 0.038) and was greater in
    adults than children (100 vs. 36 events/100
    patient years, P 0.036).

Severe hypoglycaemia was reduced during CSII
compared with MDI, with a rate ratio of 2.89 (95
CI 1.45 to 5.76) for RCTs and 4.34 (2.87 to 6.56)
for before/after studies rate ratio 4.19 (2.86
to 6.13) for all studies.
The mean difference in glycated haemoglobin
(HbA1c) between treatments was less for RCTs
0.21 (0.130.30) than in before/after studies
0.72 (0.550.90) but strongly related to the
initial HbA1c on MDI (P lt 0.001).
The worse controlled subject on MDI injections
enjoyed the most improvement on the insulin pump
Pickup et al. 2002 meta-analysis of CSII and MDI
in DMI
  • Method Metaanalysis of 12 randomised controlled
    trials (1975 -2000). 301 people with DMI
    allocated to insulin infusion and 299 allocated
    to insulin injections for between 2.5 and 24
  • Results Glycated haemoglobin was also lower in
    people receiving insulin infusion (0.44, 0.20 to
    0.69), equivalent to a difference of 0.51.

BMJ 2002 Mar 23324(7339)705
Blood glucose variability is less in CSII
compared to MDI
  • Bruttomeso et al. 2007.
  • Method Randomized cross-over study. Compared
    CSII and MDI in patients with DM I.
  • 39 DM I patients with previously well controlled
    diabetes on CSII for at least 6 months were
    randomly assigned to continue CSII with lispro or
    switch to MDI with lispro and glargine.
  • After 4 months they were switched to the
    alternative treatment.
  • Primary end-points
  • Blood glucose variability was analysed using
    various measurements glucose standard deviation,
    mean amplitude of glycaemic excursions (MAGE),
    lability index and average daily risk range
  • Secondary end-points blood glucose profile,
    HbA1c, number of episodes of hypo- and
    hyperglycaemia, lipid profile, free fatty acids
    (FFA), growth hormone and treatment satisfaction.

  • Results
  • Overall, CSII glucose variability was 512 lower
    than during MDI with glargine.
  • The difference was significant only before
    breakfast considering glucose standard deviation
    (P 0.011), significant overall using MAGE (P
    0.016) and lability index (P 0.005) and not
    significant using ADRR.
  • Although HbA1c was similar during both
    treatments, during CSII blood glucose levels were
    significantly lower, hyperglycaemic episodes were
    fewer, daily insulin dose was less,
  • FFA were lower and treatment satisfaction was
    greater than during MDI with glargine. The
    frequency of hypoglycaemic episodes was similar
    during both treatments.

Diabet. Med. 25, 326332 (2008).
Improved Quality of Life with CSII vs. MDI
  • Flexibility in the timing of meals
  • Ability to use bolus insulin (rapid-acting
    insulin) whenever needed.
  • Ideal for patients who eat often or erratically
    or for patients who want the flexibility to eat
    what and when they want without compromising
    glycemic control.
  • Using an insulin pump means eliminating
    individual insulin injections
  • Insulin pumps allow you to exercise without
    having to eat large amounts of carbohydrate

Scheidegger et al. 2007. CSII effects on quality
of life.
  • Methods
  • Diabetes-specific quality of life was measured
    with the DSQOLS-Questionnaire in 81 adult
    subjects with DM I on MDI and 78 subjects on CSII
    (cross-sectional study).
  • 19 subjects were followed prospectively,
    measuring their quality of life before and after
    switching from MDI to CSII (longitudinal study).
  • Results
  • Patients on CSII were more satisfied with their
    treatment in respect to
  • their metabolic goals, psychosocial factors,
    physical performance, protection from long-term
    complications and hypoglycaemia.
  • Furthermore, the subjects on CSII experience
    greater flexibility in their daily routines,
    leisure time and diet than the subjects on MDI.
  • Overall quality of life (29 points, 95CI 3 to
    54) were significantly better in CSII compared to
    MDI only in the longitudinal study.

Swiss Med Wkly 2007137476482.
Hoogma et al. Comparison of CSII and MDI on
quality of life
  • Methods
  • The 5-Nations trial was a randomized, controlled,
    crossover trial conducted in 11 European centres.
  • 272 patients were treated with CSII ? MDI or MDI
    ? CSII x 6 months.
  • 3 questionnaires DQofL, SF-12 health survey
    questionnaire, Lifestyle and manageability of
  • Results
  • The overall DQoL score was significantly higher
    for CSII at the end of treatment compared with
    MDI (75 vs. 71, P lt 0.001), indicating a positive
    impact on QoL.
  • Improvements in treatment satisfaction (P lt
    0.001), treatment impact (P lt 0.001) and a
    significant reduction in diabetes related worry
    (P lt 0.01) when using CSII compared with MDI.
  • SF-12 questionnaire improvements in perception
    of mental health when using CSII compared with
    MDI (P lt 0.05).
  • Lifestyle and manageability questionnaire more
    flexibility with regard to eating habits (P lt
    0.001) and lifestyle flexibility and sleep
    patterns (P lt 0.001) when using CSII compared
    with MDI.

Insulin Pump Therapy in DM2
  • 1) Glycemic control in DM 2 with insulin pump
  • Herman et al. CSII vs MDI in older adults (gt 60
    years) with DMII and marked obesity
  • Method 2-center, 12-month, prospective,
    randomized, controlled clinical trial compared
    the efficacy and safety of CSII with that of MDI
  • In this population, patients treated with both
    CSII and MDI achieved excellent glycemic control
    with good safety and patient satisfaction.

CSII group HbA1c 6.6 (Mean A1c fell by 1.7
1.0) MDI group HbA1c 6.4 (Mean A1c fell by 1.6
Diabetes Care. 2005281568-1573.
  • There was no statistically significant difference
    in hypoglycemic events or severe hypoglycemic
    events between treatment groups however, there
    was a trend for less hypoglycemic events with
  • CSII group minor (self-treated) hypoglycemia
  • MDI group minor (self-treated) hypoglycemia 90.
    (P 0.17)
  • CSII group severe hypoglycemia 3 / 48
  • MDI group severe hypoglycemia 6 / 50. (P 0.49)
  • It is not clear if this study of elderly patients
    can be extrapolated to most patients with type 2
    diabetes. Moreover, it suggests that MDI should
    be attempted in elderly patients with marked
    obesity before considering insulin pump therapy.

  • Jeiter et al. meta-analysis of 2 randomized
    control trials
  • In patients with type 2 diabetes mellitus, CSII
    and MDI treatment showed no statistically
    significant difference for HbA1c.
  • Cross-over trial of CSII and MDI
  • Method 40 obese, insulin-treated patients with
    type 2 diabetes were randomized to treatment with
    CSII or MDI therapy.
  • At the end of the first 18-week treat treatment
    period, patients underwent a 12-week washout
    period during which they were treated with MDI
    plus metformin.
  • They were then crossed over to the alternate
    treatment for an 18-week follow-up period.
  • Results of the intention-to-treat analysis showed
    that CSII was superior to MDI in reducing A1C
    values. There was no significant change in weight
    or insulin dosage.

Diabet Med. 2005221037-1046.
Quality of Life improved with CSII compared to
MDI in DM2
  • Method 132 CSII naive patients with type 2
    diabetes were randomly assigned (11) to CSII
    (insulin aspart) or MDI therapy (bolus insulin
    aspart and basal NPH insulin).
  • Multicenter, open-label, randomized,
    parallel-group, 24-week study.
  • A total of 93 of CSII-treated patients preferred
    the pump to their previous injectable insulin
    regimen for reasons of convenience, flexibility,
    ease of use, and overall preference.

Diabetes Care. 2003262598-2603.
What are the disadvantages of insulin pumps?
  • 1) Expensive cost of insulin pump therapy
  • The costs of the pump and supplies are higher
    than those of ordinary syringes and needles.
  • Cost of pump 3000 - 5000. Insulin infusion
    lines, syringes, tapes, batteries can add extra
    40 50 / month.
  • 2) Complications
  • Moreover, approximately 40 percent of patients in
    one large study had one or more acute
    complications (such as infection at the site of
    needle insertion) during 3000 patient-months of
    treatment. (JAMA 1984 Dec 21252(23)3265-9.)
  • A second study found that 86 percent of patients
    had at least one infusion-system failure in a
    12-month period. (Diabetes Care 1986

  • Blockage or leakage in the syringe or the
    infusion set or connectors, causing an
    interruption of infusion flow. These issues now
    occur less commonly with more modern pumps and
  • Any interruption in continuous flow can lead very
    quickly to hypoinsulinemia, hyperglycemia, and
    possibly diabetic ketoacidosis.
  • 3) Bothersome to wear an insulin pump
  • Patients may feel "tethered" to the pump at all
  • Complaints that the treatment is awkward,
    uncomfortable, embarrassing, or unpleasant,
    particularly when bathing or having sexual

Can insulin pump therapy be used in pregnancy?
  • A 2008 Cochrane review to compare CSII with MDI
    of insulin for pregnant women with diabetes.
  • Search strategy Articles were searched from the
    Cochrane Pregnancy and Childbirth Groups Trials
    Register (November 2006).
  • Selection criteria Randomised controlled trials
    comparing CSII with MDI for pregnant women with
  • Primary outcome 1) perinatal mortality 2) fetal
    anomaly 3) hypoglycemia/hyperglycemic episodes
    requiring intervention 4) admission and length of
  • Secondary outcomes multiple additional outcomes
    for the mother and baby

  • Results
  • Two studies (60 women with 61 pregnancies) were
  • There was a significant increase in mean
    birthweight associated with CSII as opposed to
    MDI (WMD 220.56, 95 confidence interval (CI)
    -2.09 to 443.20 two trials, 61 participants).
  • BUT lack of significant difference in rate of
    macrosomia (birthweight greater than 4000 g)
    (relative risk (RR) 3.20, 95 CI 0.14 to 72.62
    two trials, 61 participants).
  • No significant differences were found in any
    other outcomes measured, which may reflect the
    small number of trials suitable for metaanalysis
    and the small number of participants in the
    included studies.
  • No significant differences were found in
  • perinatal mortality (RR 2.00, 95 CI 0.20 to
  • fetal anomaly (RR 1.07, 95 CI 0.07 to 15.54)
  • maternal hypoglycaemia (RR 3.00, 95 CI 0.35 to
  • maternal hyperglycaemia (RR 7.00, 95 CI 0.39 to

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Cochrane Conclusion
  • There is a dearth of robust evidence to support
    the use of one particular form of insulin
    administration over another for pregnant women
    with diabetes.
  • The data are limited because of the small number
    of trials appropriate for meta-analysis, small
    study sample size and questionable
    generalisability of the trial population.
  • Conclusions cannot be made from the data
    available and therefore a robust randomised trial
    is needed. The trial should be adequately powered
    to assess the efficacy of continuous subcutaneous
    insulin infusion versus multiple daily injections
    in terms of appropriate outcomes for women with

Can insulin be used perioperatively?
  • Little evidence regarding CSII and perioperative
  • 2 case studies. No randomized controlled trials
  • First case study DM I who wore his continuous
    subcutaneous insulin infusion (CSII) pump during
    general anesthesia for surgical repair of a
    herniated lumbar disk. Blood glucose levels were
    stable throughout the perioperative period.
    Little or no extra work was required of the CRNA.
  • Second case study A 61-year-old male, while
    recovering from a Whipple's procedure for
    pancreatic carcinoma, was treated for 13 days
    with an insulin infusion pump for diabetes
    exacerbated by enteral hyperalimentation.
  • Treatment with continuous subcutaneous insulin
    infusion resulted in improved blood glucose
    control. Associated with this improvement was a
    reduction in plasma cholesterol, triglyceride and
    free fatty acid levels. Plasma epinephrine,
    norepinephrine, glucagon and cortisol
    concentrations were also lowered although growth
    hormone levels remained unchanged.

Take Home Message
  • Insulin pump therapy is an alternative to MDI in
    diabetic patients
  • In DM 1, insulin pump therapy compared to MDI may
    lead to improvements in glycemic control with
    less frequent episodes of hypoglycemia, less
    glucose variability, and improved quality of
  • There is less evidence available in DM 2, but
    current trials suggest no additional benefit in
    glycemic control with CSII compared to MDI.
    However, CSII may be associated with improved
    quality of life.
  • There is currently very little evidence for the
    benefit of insulin pump therapy in pregnancy or
    perioperative management of diabetes.

Thank you