Title: Evaluation of the teaching utility of a computerized diabetes simulation program

Background Information: Your doctor / diabetes clinic is interested in using a novel computerized diabetes simulation program for educational purposes. This is believed to be of use in recreating clinically realistic diabetes situations for interactive simulation. However, while a large number of people have been making use of this simulation program for diabetes teaching and self-learning, its actual utility for supporting the education of people with diabetes mellitus remains to be objectively demonstrated in a scientific manner. The current study aims to address this issue by conducting a ‘randomised controlled trial’ using the simulation program in diabetes lessons. The aim is to recruit a group of people who have diabetes. Half the group will be randomly assigned to receive lessons with the diabetes simulator first, while the other half of the group will receive standard (or conventional) diabetes education lessons first. Those that are randomly assigned to receive conventional lessons first, will subsequently be offered a set of lessons with the diabetes simulator, a month after the end of their conventional lessons. In this way everyone who participates in this study should have a chance to receive lessons involving the novel diabetes simulator.

Understanding of Participant: I have been asked to take part in a study that evaluates the usefulness of a novel diabetes simulation program. To this end I will take part in a study consisting of six conventional lessons (with graphs, transparencies, oral presentations) and / or six lessons with a computerized diabetes simulator. I understand that the exact dates and times of the lessons will be arranged directly with my fellow participants and I, and that the sequence of my participation in the study (conventional / standard lessons first or simulation lessons first) will be randomly determined.

My involvement will be limited to:

1. I will complete a logbook with my blood glucose values resulting from self-monitoring the week before the start of the lessons, and the week following the end of the lessons. I will also keep a log of any symptomatic hypoglycemic episodes (‘hypos’).
2. I will have my glycosylated hemoglobin (HbA_1c) level checked before the start of the lessons, and one month after the end of the lessons.
3. I will complete some questionnaires regarding my subjective feeling of well being and the impact of the lessons on my perceived well being.
4. I will participate actively in the lessons.

I understand that there is no risk to my health from this study, and that no form of medical therapy will be introduced for study. I note that the simulator cannot be used to tailor my individual therapy. I appreciate that the only aim of the simulation program is to help me understand the mechanisms that govern blood glucose control in the human body, so I may understand better the processes involved in balancing insulin and diet in diabetes therapy. However it is quite clear to me that any insulin dosage adjustments made during the course of the study will be absolutely independent of the simulator, and will be discussed fully with my diabetologist / diabetes educator, as per normal.

I agree not to make use of the computerized diabetes simulation program myself during the period of the study to avoid unnecessarily influencing the results.

 

The study has been explained to me by _________________________________________

and I have had all my questions answered.

Participant’s name: (please print) ________________________________________________

 

Participant’s signature: _______________________________________________________

 

Date: _______ /________________ / 2001

 

Principal Investigator: (Dr. __________________________________ **) (** Please print name)

 

Principal Investigator’s signature ________________________________________________

 

Date: _______ /________________ / 2001

 

Witness: Diabetes Educator / Nurse ( _________________________________________ **)

 

Diabetes Educator / Nurse’s signature __________________________________________

 

Date: _______ /________________ / 2001

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Centre Name: Department of Diabetes / Endocrinology* (* Please delete as applicable)

 

Hospital / Clinic: _____________________________________________________________

 

Clinic Address: ______________________________________________________________

 

__________________________________________________________________________

 

 

Centre ID Number (if applicable): ___________________________________

 

Local Ethical Committee Reference Number (if applicable): __________________________

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