insulin pumps

Initiating Out Insulin Pump Therapy
Highlights of an Outpatient Education Program
Ever since insulin was discovered in 1921 for the treatment of diabetes mellitus doctors have debated how low blood glucose levels should be maintained. The definitive information that the glucose values should be kept as close as possible to the non-diabetes population has come only relatively recently in 1993 with the publication of the Stockholm Diabetes Intervention Study and the Diabetes Control and Complication Trial. 1, 2 Both definitively demonstrate that improvement in glycemic control can significantly reduce the incidence of microangiopathic complications.

People with type 1 diabetes face the challenge of trying to achieve and maintain chronic near normoglycemia and are often unable to achieve it unless they are intensively treated in all components of diabetes management:

1. 

The patient should understand the basics of carbohydrate counting and flexible meal planning.

2.

Know how to exercise safely.

3.

Be able and willing to use SMBG.

4.

Be instructed in how to administer daily insulin adjustments properly.

5.

Be able to implement sick day rules for insulin and diet.

6.

Be able and willing to maintain close contact with their health care providers.

7. Remain well motivated and cooperate with the health care team.

Currently the number of people with diabetes who have chosen insulin pump therapy over conventional therapy is steadily increasing. Currently about 5% of the people with type 1 are on CSII. Future projections are that there will be a significant rise in the number of insulin pumps used in the next decade.

There is no agreement between studies comparing glycemic control in patients using continuous subcutaneous insulin infusion (CSII) versus multiple day injections (MDI) 3,4,5,6. The rationale for the use of an insulin pump is that it offers a more physiologic mode of insulin delivery; thus avoiding some problems associated with depot injection therapy.

Intermediate and long acting insulins have absorption variability that ranges from 10 to 52% 7,8. Continuous subcutaneous insulin infusion (CSII), using only regular or lispro insulin, lessens the problem caused by the absorption variability and has a more predictable insulin absorption than multiple daily injections (MDI). It has been suggested by some studies that the reproducibility of the insulin absorption may be even better with lispro as compared to regular 9,10. The degree of diabetes control may be improved without increasing the risk of hypoglycemia and may provide the rapid action ideal for use with CSII 11,12,13,14 There are conflicting results as to whether there is an increased risk of DKA when the insulin infusion is interrupted.15, 16. In Europe LISPRO is already labeled for pump use, and in general we have a good experience but it seems prudent that the patient be aware of this potential danger and should pay extra attention to self monitoring of blood glucose and DKA prevention guidelines.

Other benefits of CSII include risk reduction of hypoglycemia 17,18, especially for those with severe recurrent hypoglycemic episodes; due to hypoglycemia unawareness 19.

Additionally pump therapy allows individuals to live a more normal lifestyle than MDI; avoiding the rigid dietary schedule that is not always possible to follow in the " real world ". Pump patients appreciate the increased freedom for their weekend sleep without sacrificing their glycemic control. 20 This feeling of freedom, plus good metabolic control, is a major reason for people reporting a decrease in depression and improvement, of their overall health status 21,22.
Choosing the candidate

Few things are more important, for a successful insulin pump experience, as finding the appropriate candidate.

CSII is not for every one. There are some patients who are not suitable because they exhibit some of the well-established contraindications summarized in the following table:

Contraindications for CSII
• 

Unwilling to do 4 or more SMBG a day and adjust insulin accordingly

Lack of acceptance of diabetes

Unwilling to call their health provider when problems arise or to unable to follow the scheduled medical visits

Unable to handle an insulin pump technically due to severe physical disabilities

Severe and unstable psychiatric conditions

Intensive fear of needles or pain

Lack of positive family and peer support


CSII is specially indicated in those highly motivated individuals who are unable to achieve acceptable control under MDI or simply because they choose or need to have more freedom in their lives.

In our own practice the first reason for initiating CSII was recurrent hypoglycemia and hypoglycemic unawareness.
Some pregnant women also choose continuous subcutaneous insulin infusion (CSII) and they generally do well because the pregnancy is a extremely highly motivating event 23,24.
We believe that in order to avoid frustration and discontinuation of therapy it is mandatory to be honest and explain clearly to patients what to expect from CSII. Obviously, it is not a cure, or a magic solution, but it may be a good alliance in their striving to live a good life, getting the most out of all their efforts they put into maintaining reasonably good diabetes control.
Implementation of the Program

Table 2 lists the main topics to be covered during the eight-hour course, for initiation of CSII.
Naturally there are variations and the usual length of time necessary to master CSII varies among individuals. Our program takes 3 weeks to complete, but it is flexible and adaptable to each individual learning capacity.

Key Points of an eight hour Pump initiation Program
Week 1
  1. Review course of intensive diabetes management
    • Diabetes knowledge test.Assesment of patient knowledge and attitudes
    • Review and update those concepts needed as has been shown
    from the answers to the diabetes knowledge test

  2. SMBG with insulin pump therapy
    • At least 3-4 daily SMBG readings
    • Recording and using the results to get the most out of them (algorithms)

  3. Carbohydrate Counting
    • Applying your knowledge in carbohydrate counting to CSII
    • Both work well together
Week 2
  1. How an insulin pump works: Learning to think like a pancreas
    • Timing and action of your insulin
    • The basics of basal and bolus
    • Practical exercises on the blackboard

  2. Basic pump operation (1)
    • Select and activate pump functions
    • Programming and clearing memory

  3. Basic pump operation (2)
    • Infusion site care
    • Preventing site infections
    • Why your pump will beep.
Week 3
  1. Sick-day guidelines
    • Preventing DKA
    • How to respond to extreme low and high blood sugar
    • Disconnecting your pump
    • Foods and liquids suggested for sick-days
    • Asking for help. When to call to your health care team?

  2. Useful tips for using pump therapy in the "real world"
    • Swimming
    • General exercise guidelines
    • Clothing
    • Sexual activity
    • Other

First week:
The first 3 hour session will be covered during the first week in (3) three separate days allowing the patients to learn and discuss their questions with the diabetes health care team.
From the start of our program, we emphasize the patient’s role as the real decision-maker. We as a health care team provide diabetes expertise, education and psychological support but they must see us as partners in the care process. Thus from the first encounter with the patient we try to avoid formal lectures about the facts and try to build the confidence that will allow us to talk frankly to the patient to promote a problem-solving approach.
First, we start by reviewing and updating basic diabetes knowledge. Most of our CSII candidates already use MDI and already have a good level of basic diabetes education. We also assess their attitudes towards a new therapeutic method.
We ask the patient to bring along a support person, who will hopefully be present during the entire educational process.
When the first training week is completed, we put the patient in contact with a similar age pump user because, undoubtedly, the advice of a peer who has experienced the challenges of going on an insulin pump can best help an insulin pump "rookie".

Second week: During the second week we explain the technical aspects of the pump during two different (1) one hour sessions and we allow the patient to take home the pump so they can practice, "hands on" pump programming.

Third week: During the third week we see the patient the two first days and then he is closely monitored by phone. The patient arrives to the clinic early before breakfast following the educational session. They start to wear the pump during the morning, performing a midmorning BG reading and returning to the clinic to discuss their experiences. Then the pump is disconnected prior to their leaving the clinic. The next day, after the last educational session, the procedure is the same.
During these two consecutive days, the patient must make an early morning phone call to the clinic to discuss with the boluses and their basal rates; depending upon the basal BG. During the first days of pump therapy we ask the patients to try to keep the carbohydrate contents, of their meals, as constant as possible in order to better calculate the right insulin dosage. The patient will wear the pump until bedtime disconnecting it before going to sleep. Finally, on the fifth day of wearing the pump, the patient is allowed to sleep with the pump and is required to check the 3 a.m. blood glucose every night at least for the first week and weekly thereafter.
Finally, the patient receives a personalized certificate for the completed course signed by all the team members who participate in the course.

For every CSII outpatient initiation program, it is mandatory to have a 24 hours "Diabetes Hot Line" attended by an expert staff. The educational process is an "on going" process and a Pump Review Course is a MUST at least biannually, for all insulin pump users. If possible, the health care provider should schedule it upon completion of the course. All the additional communications channels should be kept open in order to keep the patient updated and motivated, like fax or, e-mail reminders. We also offer them update specific information about pump therapy and general diabetes education in our website www.clinidiabet.com
Advantages of this Program

We think that the 3-week program has advantages over the intensive inpatient programs and we have summarized them in the next table:

3 Week Outpatient Program. Possible advantages
Allows the patient:

• 

To go through an step by step educational process

Starting out CSII in "real life" situations while continuing their normal lives with minimun interruption

A more exact adjustment of their basal and bolus insulin requirements

An easier psycological adjustment

To reduce the cost of CSII initiation


We also encourage our patients to attend CSII support group sessions because it is normal to sometimes feel overwhelmed and to experience some degree of frustration, especially when things may happen differently than you planned. In these situations the support group may be extremely helpful.
The Future

Hopefully in the next decade implantable glucose sensors will be a reality and will provide this basic information to the pump The pump will provide insulin automatically and by then we hope insulin pump therapy will be a very common form of therapy for people with type 1 diabetes.
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  2. The Diabetes Control and Complications Trial Research Group.The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.N.England J.Med 329:977-986,1993

  3. Schiffrin A, Belmonten MM,.Comparison between continuous subcutaneous insulin infusion and multiple injection of insulin a one year prospective study.Diabetes 31:255-264,1982

  4. Lecavalier l,Havrankova J,Hamet P,Chiasson JL.Effect of continuous subcutaneous insulin infusion versus multiple injections on insulin receptors in insulin –dependent diabetics Diabetes Care 10:300-305,1987

  5. Diabetes and complications trial Research Group. Implementation of treatment protocols in the Diabetes Control and Complications Trial.Diabetes Care 18:361-376,1995

  6. Marshall SM,Home PD,Taylor R,Alberti KG. A randomised crossover trial of continuous subcutaneous insulin infusion in the regular diabetic clinic Diabet.Med.5:521-545,1987

  7. Laurizten T,Pramming S,Gale EAM,Deckert T,Binder C.Absortion of isophane (NPH) insulin and it clinical implications Br.Med.J. 285:159-162,1982.

  8. Lauritzen T, Pramming S, Deckert T, Binder C: Pharmacokinetics of continuous subcutaneous insulin infusion. Diabetologia 24:326-329,1983

  9. Johansson UB,WredlingPEL,Adamson U..Reproductibility absortion with insulin lispro and regular –Insulin During CSII Oral comunication 0040 ADA Annual Meeting Chicago 1998

  10. Braak EW,Woodworth JR,Bianchi.R.Cerimeli B,Erkelens DW,Thijssenn, Kurtz D.Injection
    site effects on the pharmacokinetics and glucodynamics of insulin lispro and regular insulin.Diabetes Care 19:1437-1440,1996

  11. Zinman B,Tildesley H,Chiasson JL,Tsuy E,Strack T.Insulin lispro in CSII:results of a double –blind crossover study-Diabetes 46:440-443.1997

  12. Tsuy E,Chiasson JL,Tildesley. H,,Barnie A,Simkins S,Strack T,Zinman B.Counterregulatory hormone responses after long-term continuous subcutaneous Insulin Infusion with Lispro Insulin.Diabetes Care 21:93-96,1998

  13. Holcombe J,Raskin P,Tamborlane W,Malone J.Humalog versus Velosulin BR in continuous subcutaneous Insulin Pumps ADA Annual Meeting. Chicago 1998

  14. Schamauss S,Konig A,Landgraf R.Human insulin analogue LYS (B28),PRO(B29):the ideal pump insulin?.Diabet.Med 15:247-249,1998

  15. Attia N,Jones TW,Holcombe J,Tamborlane WV.Comparison of human regular and lispro Insulins after interruption of CSSI and in the treatment of acutely descompensated IDDM.Diabetes Care 21:817-821,1998

  16. Reichel A,Rietzsch H,Kohler HJ,Pfutzner A,Gudat U,Schulze J. Cessation of insulin infusion at night-time during CSII-therapy comparison of regular human insulin and insulin lispro.Exp Clin Endocrinol Diabetes. 106:168-172,1998

  17. Eichner HL,Selam JL,Holleman CB,Worcester BR,Turner DS,Charles MA. Reduction of severe hypoglycemic events in type 1 insulin dependent diabetic patients using continuous subcutaneous insulin infusion. Diabetes Res 8:189-193,1989

  18. Bode BW,Sleed DR,Davidson PC. Reduction in severe hypoglycemia with long term continuous subcutaneous insulin infusion in type 1. Diabetes Care 19:324-327,1996

  19. Hirsch IB,Farkas-Hirsch R,Cryer PE.Continuous subcutaneous insulin infusion for the treatment of diabetic patients with hypoglycemia unawareness.Diab.Nutr. Metab. 4:41-43,1991

  20. Guerci B,Meyer L,Delbachian I,Kolopp M,Ziegler O,Drouin P.Blood glucose on Sunday in IDDM patients: intensified conventional insulin therapy versus continuous subcutaneous insulin infusion.Diabetes Res Clin Pract 40:175-180,1998

  21. Haakens K,HansenKF,Dahl-Jorgensen K.Vaaler S,Mosand R.Continuous subcutaneous insulin infusion (CSII)multiple injection (MI) and conventional insulin therapy in selfreflecting insulin-dependent diabetic patients J,Inter,Med, 228:457-464,1990

  22. Schiffers T.Quality of life with intensive insulin therapy:a prospective comparison of insulin pen and pump.Psycother.Psycochosom.Med Psychol 47:249-254,1997

  23. Rudolf M.,Corstan D,Sherwin R,Bates SE,Felig P,Genel M,Tamborlane WV.Efficacy of the insulin pump in the home of pregnant Diabetics.Diabetes 30:891-895,1981

  24. Drexler AJ..Pump therapy in preconception and pregnancy in: The Insulin Therapy Book:Insight from the Experts.Fredikson l.Ed.Minimed Inc. Los Angeles 147-150,1993
NOTE: this article was publish partly in Diabetes Spectrum Vol 12 Number 3:86-88(1999)
F, Menendez Alvarez and R.M.Antuña de Alaiz both work at Clínica Diabetológica,
an outpatient diabetes care and education center in Gijón. Nothern Spain.
F. Menendez Alvarez was trained in insulin pump therapy
at the University of Washington Diabetes Care Center in Seatle. WA
Ramiro Antuña de Alaiz
Educational Treatment Unit
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