insulin pumps

DESG Teaching Letter
Education of People with Diabetes to the use of Hi-Tech Devices

Human nature does suffer less from lack of power or time than from lack of continuity *

The use of Continuous Subcutaneous Insulin Infusion (CSII) is progressively increasing worldwide, while in some European countries its implementation was low until a few years ago. The reasons for this recent increase are diverse: a) higher standards for the quality of diabetes treatment; b) increased awareness in health economics of the impact of diabetes related morbidity on overall health costs; c) increasing evidence that pump therapy is as effective and safe as the most intensified insulin treatments known so far; d) technical, functional and aesthetic improvements of the systems available; e) development of patient education and care, especially team care approach.
Health professionals caring for people with diabetes should also be aware of possible limitations to the use of Hi-Tech devices: a) lack of flexibility about, or fear of technologies; b) lack of knowledge of the Hi-Tech device and/or lack of the requirements for patient training; c) lack of support from the diabetes team; d) poor or insufficient basis for collaboration between providers and patient; e) reluctance to support new therapies.

* The Roman historian G.Sallustius Crispus (86 B.C. to 35 B.C.), a native of the region of Aquila where the Celano DESG workshop was held, in his introduction to "The War of Jugurta".
Aims

This teaching letter should enable the reader to:

•  Deliver general information on CSII therapy to candidate users

Be aware and explain the usefulness and limitations of CSII

Provide information about the current state of intraperitoneal insulin therapy (IPII, with or without implantable pump)

Discuss current knowledge on glucose sensors and other high tech devices
Requirements for Successful and Safe CSII Implementation

Successful implementation of CSII depends both on patients and the care team. Patients should have the highest possible motivation, cognitive and problem solving skills, and social support. The care team has the responsibility of selecting, educating and assisting patients in the best way. Clearly, physicians, nurses and dietitians willing to provide CSII treatment need specific training.

Patients selection

The CSII is not currently considered suitable for people falling under the following categories: a) patients with major handicaps, e.g. severe sensory impairments, dexterity deficits, coagulopathies, etc.; b) psychological resistance (i.e. distortion of body image); c) inability to adapt to illness; d) unwillingness to perform self-monitoring of blood glucose; e) poor or insufficient basis for cooperation between patient and health care providers; f) major psychiatric illness; g) uncertainty of social support, e.g. family, friends… ; h) illiteracy.

Health Care Providers should be able to explain to such patients who nonetheless are willing to use the pump, why pump therapy is inappropriate for them, stressing its burdens and disadvantages, avoiding as much as possible to induce feelings of rejection. Patient education should lead these patients to autonomously decide that the treatment they hoped in is in fact not suitable for them (at least for the present, in order to leave an open door to hope).

Examples of effective arguments are: a) the pump is not an "artificial pancreas", as many erroneously believe (in fact no closed-loop system is available so far); b) the patient on CSII depends on a complex electro-mechanical device; c) his/her dependency on the medical system may often be increased, rather than decreased as one usually expects.

Requirements for successful and safe CSII implementation
Institutinal Patient
A well organized diabetes care team should be available, ensuring:

•  structured method of interviewing potential pump users (oral or written)

a trial training period with the pump before deciding on permanent use of CSII (7 to 30 days)

specific training to prepare patients for CSII

24 hour call service for emergencies or technical problems

essential supplies, e.g. spare pumps, batteries, catheter material

continuous update on CSII technology development
To use CSII successfully and safely, the patient needs to:

•  understand the concept of basal and bolus insulin requirement

adapt insulin therapy to changes in daily activity or to other changes of insulin need, under normal or exceptional circumstances (including illness)

handle correctly and safely all the technical elements connected with CSII

perform multiple blood glucose self measurements on a regular basis

be able to switch, if necessary, from CSII to multiple daily injections and vice versa

follow the scheduled consultation program

be able to identify emergencies that require medical help

Further recommendations

•  Access to a support group of current CSII users may be of great help for the patient considering CSII

Certification of achievement (knowledge and handling) and regular updating and training courses may enhance the motivation of the pump user

The patient must be equipped with a CSII survival kit, especially when traveling, i.e. spare batteries, catheters, long and short-acting insulin, insulin syringes…

An identity document carrying precise information on the type of pump, it’s producer, the insulin brand used and the phone number of the healthcare team responsible for CSII should be provided to every user of an insulin pump

How to approach the patient at the star of CSII

What is an insulin pump?

An insulin pump is a battery-powered electro-mechanical device that contains an insulin-filled reservoir and continuously delivers rapid or short acting insulin into the subcutaneous tissue, by means of an infusion set.

The infusion takes place continuously during the 24 hours at different rates: a basal rate which has to satisfy the insulin need in the fasting state; variable boluses at mealtimes, to satisfy the higher post-prandial insulin need, or in other moments to correct for occasional unexpected high blood glucose levels.

It is important to state that, in spite of highly effective hard- and software components, an insulin pump is not a fully automatic device. Both the basal rate and the time and amount of the boluses are decided by the patient, according to the information provided by the results of self blood glucose monitoring (SBGM).

Advantages of CSII

When the patient is offered the opportunity to start the CSII, the HCP should encourage the patient to make a decision by pointing out the appropriate advantages, both clinical and of improvement of quality of life.

Clinical Advantages

•  Fewer and less severe hypoglycemic episodes

Reduced variability of glucose values

In early diabetic pregnancy, easier management of hyperemesis

Increased reproducibility of insulin action

More physiologic insulin profile over 24h (reduced dawn and/or dusk phenomenon)

Quality of Life Advantage

•  Greater flexibility in life style (increased freedom in the organization of daily activities and dealing with unplanned events, e.g. exercise, meals…)

Fewer insulin injections

Useful aid to overcome burn out syndrome in patients with diabetes.
Disadvantages of CSII

Upon initial presentation of the CSII, the HCP should also point out the possible disadvantages that the pump therapy may involve.

•  Visibility of the device to others

Greater involvement and attention required than with multiple daily injections

Possible mechanical and electronic failures

Cost of the pump and supplies

Are there specific risks associated with CSII?

•  Ketoacidosis may develop within hours due to malfunction of the pump, the infusion system (including displacement or obstruction of the subcutaneous catheter) and/or to inattention of the patient. Since there is no long-acting insulin and only a very small subcutaneous insulin depot of rapid- or short-acting insulin, interruption of insulin infusion produces an absolute deficit of insulin within few hours. This major risk can be minimized in well trained patients, and where support of the health care team is guaranteed.

Infection at the site of the catheter is possible but does not represent a major health risk. Its frequency depends on the patient’s behaviour . It can be minimized if the patient follows the rules for regular catheter replacement, change of the site of infusion and hygiene.

Allergic dermatitis is a rare occurrence. Should the problem arise a change of catheter or dressing material may be necessary.

Severe lipodystrophy has been very rarely associated with CSII. It’s presence may be a reason to discontinue CSII.

Weight gain might be a problem as in all intensified insulin regimens. However, it can be avoided by correct counseling on nutrition and physical activity.

Intraperitoneal insulin infusion with or without an implantable pump

The intraperitoneal infusion of insulin would allow a more physiological delivery of insulin than CSII, since the barrier of subcutaneous insulin absorption is eliminated.

In contrast to CSII therapy, implantable pumps must be surgically implanted in the lower abdomen and connected to an intraperitoneal catheter. The pump contains a reservoir for insulin that has to be refilled transcutaneously under sterile conditions and in the HPC office. The effectiveness of this method has been proved, but there are numerous technical problems, related to the pump, the catheter system, and the long-term stability of insulin at body temperature. Moreover it is invasive and highly expensive.

On the other hand, the intraperitoneal access with an external pump connected to an intraperitoneal catheter (percutaneous port system) could be considered a valuable alternative to CSII.

The advantages and disadvantages of both methods should be clearly explained to candidate patients, whereas the therapeutic education and training does not differ from those required for CSII.

Glucose Sensors

One of the major limitations for the control of diabetes is the need to perform regular and frequent blood glucose determinations. The search for a reliable method to determine blood glucose concentrations in a non-invasive way has been long and tortuous. So far, the major problem is the biocompatibility and the shortness of the life cycle of the electrodes. There are at present several types of non-invasive glucose sensors undergoing clinical trial. Clearly, the reliability and safety of these instruments must be formally proven before their use can be recommended.

The expectations of people with diabetes from these devices are high and sometimes excessive. The continuous monitoring of blood glucose will probably change their quality of life, although not necessarily for the better. Possibly it will also improve the quality of blood glucose control, especially for those who suffer from wide and unpredictable blood glucose excursions at night, and those who suffer from hypoglycemia unawareness. But those who expect the miracle of automatic blood glucose control will be deceived.

Only when the glucose sensor is connected directly to the insulin pump, thus allowing a closed-loop system, the blood glucose control will be automatic, but an efficient system of this kind is still far to come.
Further sources of information

Graff M, Fredrickson L: Certified pump trainer manual, Medtronic Minimed Education Department, 1998

www.disetronic.com
www.minimed.com/doctors/md_insulinpumptherapy.shtml
www.insulin-pumpers.org
www.animas.com

How you might use this teaching letter

TIf CSII is not yet implemented in your unit, you may discuss with your team the organisational requirements to start, including the specific requirements for effective TPE. On the basis of this discussion, specific actions should be planned with a distribution of tasks and a step-by-step implementation schedule. An early action could be the visit of another unit where CSII and specific TPE are already implemented.

If CSII is already implemented in your unit, you may discuss with your team members how is TPE performed, according to different criteria: e.g. technical updating of HCPs, psycho-pedagogical training of HCPs, patients’ selection and motivation, definition of learning objectives for patients, implementation of training sessions, evaluation of results. Lists of strong and week points could be completed, and specific actions planned to improve weaknesses.

The Diabetes Education Study Group would appreciate receiving comments, suggestions and any documents developed after, or inspired by, this letter. Please send them to Prof. Aldo Maldonato, Institute Clinica Medica 2, Policlinico Umberto I, 00161-Rome, Italy.
Tel +39 06 4938 4791, Fax +39 06 4470 3133. Email a.maldonato@iol.it

The DESG Teaching Letters
This series of Teaching Letters for doctors and other health care providers involved in the daily care of people with diabetes has been prepared by the Diabetes Education Study Group of the European Association for the Study of Diabetes, with an educational grant from Servier.
The new series of Teaching Letters was drafted by a group of European diabetologists at a DESG workshop held in Celano, Italy. The authors are: R Antuña de Alaiz, E.M. Baumer, M. Benroubi, J. Boavida, A. Brooks, D Bruttomesso, R. Chlup, K. Chlupova, E. Cohelo-Moos, M.L. Cortesao-Pinto, T. Curtis, A.M. Felton, D Figuerola, D. Halimi, I. Harman-Bohem, G. Hochberg-Parer, HU Iselin, J.M. Race, P.Segal, N Sulli, A. Visser, R. Walker, G.Xuereb

The authors of the present letter are in color.
Editor-in-chief: A Maldonato, MD. Assistant Editors: D Bloise, MD, A Baldelli, MD.
Diabetes Unit, Institute Clinica Medica 2, Policlinico Umberto I, 00161 Rome, Italy.
insulin pumps > education of people with diabetes to the use of hi-tech devices