Diabetes Treatments

of use in recreating clinically realistic diabetes situations for interactive simulation. with type 1 diabetes mellitus remains to be objectively …

DIABETES TECHNOLOGY THERAPEUTICS Volume 3, Number 2, 2001 Mary Ann Liebert, Inc

Diabetes Information Technology WebWatch Questionnaires for a Randomized Controlled Trial Methodology to Evaluate the Teaching Utility of Diabetes Simulation Programs
ELDON D LEHMANN, MB, BS, BSc,1 and PATRIZIO TATTI, MD2

ABSTRACT AIDA is an interactive educational diabetes simulator which has been made available without charge on the Internet Since its launch on the World Wide Web in 1996 over 87,000 people have visited the AIDA Website–http://www2aidaorg–and over 22,000 copies of the program have been downloaded from there free-of-charge The AIDA software is believed to be of use in recreating clinically realistic diabetes situations for interactive simulation However, despite its widespread application, its actual utility for supporting the education of patients with type 1 diabetes mellitus remains to be objectively demonstrated in a clinical randomised controlled trial RCT setting The current Diabetes Information Technology WebWatch column overviews a prospective RCT methodology for formally evaluating the educational utility of an interactive diabetes simulator, like AIDA The protocol makes
use of two study arms–each receiving different educational interventions During lessons, arm A of the study will be exposed to the AIDA simulator the active intervention, while arm B the control group will benefit from conventional educational methods using standard presentations with slides and transparencies Six lessons will be held for each study arm one per week At the beginning and end of the study self-monitoring blood glucose SMBG data will be collected, details of any hypoglycemic episodes recorded, and assessments made of glycosylated hemoglobin HbA1c levels Participants will also be required to complete a detailed questionnaire to assess their self-confidence, quality of life and metabolic control, attitudes towards SMBG, and knowledge about insulin dosage calculation Comparisons will be made between arm A and arm B using unpaired statistical analyses A partial cross-over study design is also proposed whereby subsequently the control group will be exposed to the AIDA simulator during a further 6-week course of lessons This will ensure that the maximum number of subjects will eventually receive the active intervention, and will also allow further within group paired
analyses to be applied with greater statistical power This current Diabetes Information Technology WebWatch column documents two of the questionnaires which are intended to be used for this RCT approach
1 Academic Department of Radiology, St Bartholomews Hospital, London, and Department of Imaging, NHL1 Imperial College of Science, Technology and Medicine, Royal Brompton Hospital, London, UK Dr Lehmann is a codeveloper of the AIDA diabetes simulator 2 Diabetes Branch, Ospedale di Marino, Marino, Rome, Italy

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PROTOCOL AND SUBJECTS

T

has been described in detail Briefly, outcome measures which this protocol is intended to evaluate are set out in Table 1 To demonstrate an improvement in these we have proposed a randomized controlled trial RCT methodology consisting of conventional education sessions versus computer-simulation sessions, with a partial cross-over design to maximise the numbers of subjects exposed to the diabetes simulator Using such an approach, both between group and within group comparisons and statistical analyses will be possible Figures 1 and 2 summarize the overall study design Inclusion and exclusion criteria for
the study have been summarized elsewhere1 For the initial evaluation study, we are planning to enroll adult subjects with insulin-dependent type 1 diabetes, and randomly assign them to one of the two study arms arm A: simulator; arm B: conventional education [control group] However, for later studies, we may also involve patients with insulin-treated type 2 diabetes mellitus, as well as possibly diabetic adolescents/teenagers
HE PROTOCOL elsewhere 1

PRE-RANDOMIZATION BASELINE PHASE OF STUDY The pre-randomization baseline phase of the study is summarised in Figure 1 Upon recruitTABLE 1 MAIN AND SECONDARY OUTCOME MEASURES OF STUDY

Main outcome measures: 1 Improve knowledge of how to tailor the insulin dose to the specific needs of the subject 2 Improve morning and postprandial self-monitoring blood glucose SMBG data 3 Improve forward thinking ability to answer whatif type questions 4 Improve well being and self-confidence 5 Reduce the number of hypoglycemic episodes 6 Improve HbA1c 7 Achieve subject feeling of empowerment Secondary outcome measures: 8 Increase social behavior and interpersonal cooperation about diabetes 9 Help to increase confidence with a computer 10 Increase
physiological knowledge 11 Establish sample sizes required for a possible future larger-scale, multicenter study From Tatti Lehmann1

ment, all subjects will be asked to keep a log of any symptomatic hypoglycemic episodes, and collect their self-monitoring blood glucose SMBG data for 1 week before breakfast fasting and 2 h after lunch and dinner Subjects will only be included in the study if they have collected at least 75 of the SMBG data requested The patients logbook entries can be cross-verified with the memory from their reflectance meter, as required After this, subjects will be randomly assigned to either arm A or arm B of the study, using a process of stratified randomization that takes into account hypoglycemia/low blood glucose risk and the glycosylated hemoglobin HbA1c level The purpose of the stratification is to ensure that arm A and arm B of the study have similar numbers of subjects in relation to key variables that might influence outcome Therefore subjects will be stratified into four groups according to 1 low HbA1c level, low hypo risk; 2 high HbA1c level, low hypo risk; 3 low HbA1c level, high hypo risk; and 4 high HbA1c level, high hypo risk Fig 1 For the
purpose of stratification each subjects individual HbA1c level will be assessed as the average arithmetic mean of their previous 12 months HbA1c data; a low HbA1c being defined as less than the median 50th percentile HbA1c level for the whole cohort, while a high HbA1c is defined as greater than or equal to the median HbA1c level of the cohort Hypo risk is categorized based on the 1 weeks SMBG data collection; high hypo risk being defined as any symptomatic hypoglycemic events or recorded SMBG data less than 70 mg/dL 39 mmol/L during that week For the purpose of this study, low hypo risk is defined as no symptomatic hypoglycemic episodes and recorded SMBG data greater than 70 mg/dL 39 mmol/L during that week Method of randomization In order to ensure complete separation of subject recruitment and study execution from the randomization process, an external randomization service has been set up via the AIDA Website at http://www2aidaorg/random This allows subject details patient name, hospital/study number, gender, age, number of symptomatic hypos and average HbA1c

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FIG 1 Pre-randomization baseline phase of study 1 Initial
invitations/recruitment based on study inclusion/exclusion criteria 2 HbA1c level based on average arithmetic mean of glycosylated haemoglobin levels recorded during the precceding 12 months 3 Hypo/low BG risk determined from initial 7 days self-monitoring blood glucose SMBG data collection 4 Stratification ensures that equal numbers from each of the four groups end up in each of the two study arms arm A or arm B Modified from Tatti and Lehmann1

level to be entered for each study participant It is intended that entries should be made by the physician or nurse who recruited the subjects, categorised according to low/high hypo risk and low/high HbA1c levels, as outlined above Data entered in this way can then be automatically submitted across the Internet, via electronic mail email, to a co-investigator EDL in London, England Using dedicated software written specifically for this purpose

incorporating a random number generator it will be possible for this co-investigator to independently randomize participants either to the AIDA or control groups; randomization codes being returned to the referring physician/nurse by email In this way, there should be a complete division between
the recruitment, enrollment, and teaching of subjects, and their initial randomization to either arm A or arm B of the study

FIG 2 Main phase of study 1 Stratification will be according to the glycosylated hemoglobin HbA1c level and hypo/low blood glucose risk of the subjects 2 The questionnaire aims to determine the main outcome measures see Appendix 1 3 In addition to completing the questionnaire, the subjects will also be requested to complete a diary with fasting, preprandial, and 2-h postprandial blood glucose data HbA1cHbA1c will be sampled prior to the start of phase 1 and 1 month after the end of the last lesson Furthermore HbA 1c will be measured 1 month after the end of phase 2 for the subjects in arm B 4 The delay will allow resampling of HbA1c levels in the cross-over subjects and also reduce any carry-over effect on blood glucose levels–from the conventional lessons phase 1 to the simulator-based lessons phase 2 The final HbA1c for arm B will be sampled 1 month after the end of phase 2, about 20 weeks after the first sample Modified from Tatti and Lehmann1

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MAIN PHASE OF STUDY The main phase of the study is summarized in
Figure 2 Just before entering this phase, the enrolled subjects will have their baseline HbA1c measured, and they will fill in a study questionnaire This questionnaire is documented in Appendix 1 Interventions The two arms of the study will receive different interventions Arm A will use the AIDA simulator as described below, while arm B will benefit from conventional standard educational methods verbal communication with slides and transparencies The aims of the lessons provided to the two study arms will be identical, as outlined in Table 2 The study subjects will be randomized into groups of six subjects each with multiple groups planned All the study subjects will be asked not to use the AIDA simulator on their own to avoid the possibility that one over-performer can lead the group–or that the results can be biased in any way–for instance by someone in the control group arm B accessing the simulator at home Before the start of the main phase of the study, all subjects will be asked to bring with them to lessons their own SMBG data, insulin regimen, and carbohydrate intake details–for possible use during classes At the end of each lesson, subjects will be given a short,
separate generic one-page questionnaire documented in Appendix 2 to complete regarding their thoughts on the lesson, and whether they felt that they benefited from it

All subjects will go through six lessons, one each week In the description of the two study arms which follow, more detail is given about the simulator arm arm A simply because this is the novel intervention being tested However, it is intended that the duration of the lessons should be the same for both study arms approximately 6570 min

ARM A SIMULATOR ARM: PHASE 1 The participants will not interact directly with the computer–rather the teaching experts will serve as wizards or facilitators undertaking all interactions with the computer This will circumvent any problems if the participants are not computer-literate or confident to use a computer themselves Also this approach should help to avoid any learning curve effect where it takes the study participants a number of lessons to become fully familiar with the programs functions For all simulation lessons, two computer screens will be made available–linked to the same PC–ensuring that all study participants will have a good view of the computer displays At the
end of each lesson, the number of simulations run during that lesson will be recorded The topics to be covered during each lesson are summarized in Table 2

ARM B CONTROL ARM– CONVENTIONAL EDUCATION: PHASE 1 For this group, the content of a standard textbook will be used as a reference2 The principles are the same as described above for arm A and the topics will be the same as set out in Table 2, but this group will not use the AIDA simulator The general scheme of these lessons will involve conventional standard education sessions on a given topic, using slides and transparencies–followed by discussion and questions–and then a recap As for arm A, at the end of each lesson participants will be given a short, generic one-page questionnaire to complete regarding their thoughts about the lesson

TABLE 2

AIMS

OF THE

SIX STUDY LESSONS

Lesson I: learn how to match insulin and food intake Lesson II: learn about regulation of blood glucose BG levels overnight Lesson III: learn about role of the renal threshold of glucose and role of exercise Lesson IV: learn about the avoidance and treatment of hypoglycemia Lesson V: learn about behavior in case of shift work or travel abroad Lesson
VI: learn how to manage BG control in unforeseen circumstances From Tatti Lehmann1

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CROSS-OVER PHASE: PHASE 2 At the end of the control arm arm Bphase 1 there will be a gap, once phase 1 is complete, of 4 weeks, following which the subjects will complete the study questionnaire, have their HbA1c re-measured, and then enter the crossover phase of the study This will entail a further cycle of 6 lessons, exactly the same as arm A with the simulator The purpose of this partial cross-over phase is to expose the control standard education group to the simulator–and therefore increase the final sample size actually receiving the active intervention In addition to allowing between group analyses–this approach will also allow further comparisons to be made within groups of the same subjects– and therefore allow more paired statistical analyses to be used, with their associated greater statistical power

STUDY LOGISTICS It is well recognized in education that the smaller the class size the greater the educational opportunity that can be offered to participants For this study, class sizes also need to be kept small in order to allow each of the
subjects to present their own data during one of the six simulation lessons For this reason the class size will be limited to six subjects per class for both arm A and arm B It is intended for subjects to have one lesson per week–so it will take 6 weeks to run a complete course of 6 lessons Due to local time constraints and the availability of teachers, it may be necessary to run only one lesson for arm A–and one lesson for arm B–each week This means that more than one 6-week course of lessons will be required to get all the recruited subjects through the lessons

DISCUSSION FINAL OUTCOME MEASURES At the end of the study, after the interventions both of phase 1 and phase 2, the participants will be required to: 1 Collect SMBG data for 1 week, before breakfast fasting, and 2 h after lunch and dinner 2 Have their HbA1c measured 1 month after the end of the intervention 3 Provide a record of any symptomatic hypoglycemic episodes during the course of the study 4 Complete the main study questionnaire see Appendix 1–to assess their self-confidence, and well-being rated on a scale, together with their knowledge of what-if type problem solving in diabetes care An additional page of
feedback comments will be sought from the participants in the simulator arm arm A concerning what they thought about the AIDA simulation software 3 The recording of symptomatic hypoglycemic episodes will be differentiated from biochemical hypos recorded low BG levels less than 70 mg/dL [39 mmol/L] To evaluate the impact of education sessions with an interactive diabetes simulator on the well-being and short-term and intermediate metabolic control of patients with type 1 diabetes, we have designed a study protocol using a rigorous and transparent methodology The approach overviewed above, and described in detail elsewhere1 combines a prospective, randomized controlled trial with a partial cross-over design to maximise the number of subjects exposed to the simulator The biggest limitation of this approach is likely to be the availability of teachers and the time required to actually run the lessons Subjects will also need to be motivated as they will need to commit to 612 weeks of lessons However they do benefit from useful education sessions with conventional lessons and/or a simulator, so that should hopefully be enough to motivate them It should be self-evident that interactive
simulations such as those highlighted here only provide one aspect of the education required by patients with diabetes It is quite possible to envisage a study–which incorporates components of the randomized controlled trial described above–as part of the assessment of more standard educational diabetes interventions In this respect, it will be important not to

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restrict this protocol to use just with a teacher and 1-h clinic lessons For instance, it is well recognized that there are not enough resources trained diabetes educators, money, facilities, etc available for patients to be seen in clinic as often as might be regarded as ideal Fo r example, in the Diabetes Control and Complications Trial DCCT,4 patients in the intervention group were seen fortnightly and often contacted by telephone weekly5 One issue appears to be whether information technology tools might be able to assist in bridging part of the gap between what was available in the DCCT versus what is usually available routinely in day-to-day clinical practice Therefore, other questions that we might wish to address in future evaluation studies include the following–does
allowing a patient access to an interactive educational simulation program in between formal visits to a diabetes educator or clinic improve knowledge, confidence, self-management skills, or glycemic control? To be able to judge whether such software can help in this role requires a rigorous evaluation methodology1 Initially, we are trialling the approach described above in a hospital clinic setting However, longer term, it is not difficult to envisage that the basic methodology of the questionnaire approach–combined where necessary with appropriate recording of clinical biochemical data–could be equally applicable for patients with diabetes using the simulator on their own at home, 6 between clinic visits, or even possibly for health-care student evaluation eg, with medical, nursing, pharmacy, or diabetes educator students who make use of the simulations for their own education

APPENDICES Three questionnaires have been adopted for this randomized controlled study Appendix 1 provides the main study questionnaire which is divided into seven sections–covering baseline questions, plus questions about 1 patient self-confidence, 2 quality of life and metabolic control, 3 social and
emotional impact of diabetes on lifestyle, 4 attitudes towards SMBG, 5 prior knowledge about diabetes, and 6 what-if type questions and knowledge about insulin dosage calculation This questionnaire is based in part on questions from the Diabetes Care Profile, from the Michigan Diabetes Research and Training Center7 Appendix 2 gives a second generic one-page questionnaire that has been developed for use at the end of each lesson This is intended to establish if the participants felt more confident with the information provided during the lessons, and to get them to rank the information provided on a Likert scale from not at all useful through to very useful Participants are also asked what areas they felt were not adequately covered by the lessons–allowing them to offer feedback The third questionnaire–intended for completion by participants at the end of arm A of the study–after they have been exposed to the AIDA simulator has been documented in the previous Diabetes Information Technology WebWatch column3 This contains 11 questions to establish what the participants thought of the simulator, and to identify ways in which they see the simulations being applied more widely in
routine practice

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APPENDIX 1: DIABETES EDUCATION–EVALUATION QUESTIONNAIRE Date_____/_____/_____ Study no_____ RND_____

BASELINE QUESTIONS 1 How would you describe your computer skills: u Beginner u Intermediate u Expert 2 Do you personally have e-mail access at home / work? 3 Do you have online Internet / World Wide Web access at home / work? u u u YES u YES u YES u NO NO

4 Which level grade did you reach at school? _______________________________________ _ 5 Do you have a job? NO

5a –If yes, which job? _____________________________________________________________ _ SECTION I–Self-confidence Qu 6 Please rate how confident you are that you can do the following things at present 0 5 not at all confident 6a I can manage my diabetes 6b I can deal with hypoglycemic episodes 6c I can test my blood sugar correctly 6d I can have a trip abroad 6e I can do my usual physical activity 6f I can work out what to eat at home 6g I can eat out at a restaurant 6h I can control my weight 6i I can cope with my diabetes when I am sick 6j I can inject my insulin correctly 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 6 5
totally confident 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6

Qu 7 Please circle a number which indicates your answer 0 5 not at all 7a How concerned are you about your diabetes 7b How satisfied are you with your blood sugar control 0 0 1 1 2 2 3 3 4 4 6 5 extremely 5 5 6 6

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SECTION II–Quality of life and metabolic control 8a How many times in the last month have you had a low blood sugar reaction with sweating, weakness, anxiety, trembling, hunger, or headache hypoglycemia? 8b How many times in the last year have you had severe hypoglycemia with loss of consciousness or need for help? 8c How many days in the last month have you had high blood sugar with thirst, dry mouth and skin, nausea or fatigue? 8d Have you ever been hospitalized for the treatment of diabetes? 8e –If yes, how many times in the past year? 0 13 46 712 121

0

13

46

712

121

0

13

46

712

121

u

YES u

NO

_______________ 6

8f How often does your diabetes prevent you from doing your normal daily activities? 0 5 almost never; 6 5 almost always 0 1 2 3 4 5 SECTION III–Social and emotional impact of diabetes on lifestyle Qu 9 My diabetes and its
treatment prevent me from:

0 5 strongly disagree; 1 5 disagree; 3 5 neutral; 5 5 agree; 6 5 strongly agree 9a 9b 9c Having enough money Meeting work responsibilities Going out or travelling 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 6 6 6 6

9d Being as active as I would like 9e 9f 9g 9h 9i 9j 9k 9l Eating foods that I like Having a good relationship with people Going to sleep late Having diabetes makes my life difficult I am afraid of my diabetes I find it hard to believe that I really have diabetes I feel depressed because of my diabetes I have no difficulty taking care of my diabetes

9m I feel inferior to others because of my diabetes 9n I find it hard to do all my things because of my diabetes

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9o

All things considered, I feel satisfied with my life

0 0 0

1 1 1

2 2 2

3 3 3

4 4 4

5 5 5

6 6 6

9p I can do anything I set out to do 9q I would like to change many things about myself

SECTION IV–Attitudes towards SMBG Qu 10 When you do not test your blood glucose, how often is it because:
0 5 Never 10a You forgot 10b You do not believe it is useful 10c The time or place was not appropriate 10d You do not like to do it 10e You ran out of test materials 0 5 Not relevant 0 0 0 0 0 1 1 1 1 1 3 5 Sometimes 2 2 2 2 2 3 3 3 3 3 4 4 4 4 4 6 5 Always 5 5 5 5 5 6 6 6 6 6

3 5 Sometimes is relevant 1 1 0 5 Never 2 2 3 3

6 5 Always relevant 4 4 5 5 6 6

10f How important is it that you follow exactly 0 your test schedule for measuring blood glucose 10g How much does blood glucose BG testing help you control your diabetes 10h How often do you adjust your insulin dose on the basis of your BG test results? 10i How often do you adjust your diet on the basis of your BG test results? 10j How often do you adjust your physical activity on the basis of your BG test results? 0

3 5 Sometimes 2 2 2 3 3 3 4 4 4

6 5 Always 5 5 5 6 6 6

0 0 0

1 1 1

SECTION V–Prior knowledge about diabetes Qu 11 Place an X to indicate whether each item below is associated with hyperglycemia or hypoglycemia as a sign or symptom 11a No glycosuria 11b Dry skin and mouth 11c Happens slowly 11d Increased thirst u u u u Hyperglycemia Hyperglycemia Hyperglycemia Hyperglycemia u u u u Hypoglycemia Hypoglycemia
Hypoglycemia Hypoglycemia

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Qu 12 Place an X to indicate whether each item below is associated with hyperglycemia or hypoglycemia as a cause 12a Too much insulin 12b Too much exercise 12c Too much food u u u Hyperglycemia Hyperglycemia Hyperglycemia u u u u u u u u u u u u u u u Hypoglycemia Hypoglycemia Hypoglycemia

Qu 13 Insulin reactions hypoglycemic episodes are likely to occur: 13a During vigorous exercise 13b During the peak action of your insulin 13c Just before meals 13d During any of the times mentioned above Qu 14 One mL of U-100 insulin contains: 14a 1 Unit 14b 40 Units 14c 80 Units 14d 100 Units u u u u TRUE TRUE TRUE TRUE FALSE FALSE FALSE FALSE TRUE TRUE TRUE TRUE FALSE FALSE FALSE FALSE

SECTION VI–What-if type questions 15a How many extra Humalog insulin units would you need to add if you increased your 1 2 3 4 5 u dont know lunch by 20 more grams of sugar? 15b Which of the following is a reasonable action if you double the carbohydrate content of your breakfast from 20 grams to 40 grams i ii u iii u iv u u Increase your fast-acting insulin from 5 units to 6 units Increase your fast-acting insulin with 3 more units Decrease
your fast-acting insulin by 1 unit Decrease your fast-acting insulin and add 4 units of Intermediate acting insulin

15c If I normally inject 6 units of Humalog before breakfast 30 grams of carbohydrate, and my fasting blood glucose this morning is 55 mg/dL 31 mmol/L what should I do? i ii u iii u iv u v u vi u u Only inject 5 units of Humalog Inject 7 units of Humalog Add 10 grams of carbohydrate to breakfast, and make no change to my insulin regimen Add 10 grams of carbohydrate to breakfast and inject 5 units of Humalog Add 10 grams of carbohydrate to breakfast and inject 7 units of Humalog your option____________________________________ _

15d If I inject the usual dosage of short-acting insulin Humulin R, Actrapid at lunch, but I eat much less than usual, how many hours later is a hypoglycemic episode most likely? 0 1 2 3 4 5 6 7 8

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15e If I have my rapidly acting insulin Humalog injection at 8:00 am and my breakfast at 08:20 am i How many hours after the injection do you think that the peak blood glucose is most likely to occur? 0 1 2 3 4 5 6 7 hours ii How many hours after the injection do you think that a hypoglycemic episode is most
likely to occur? 0 1 2 3 4 5 6 7 hours 15f If I run for 20 minutes, 5 hours after a dose of rapidly acting Humalog insulin and my post-exercise blood glucose is 55 mg/dL 31 mmol/L, how many grams of carbohydrate 5 10 15 20 should I eat to prevent a hypoglycemic episode? grams 15g If I feel an impending hypo 25 hours after a rapidly acting Humalog insulin injection and my blood glucose is 55 mg/dL 31 mmol/L, i How many grams of carbohydrate should I eat? 5 ii Should I continue checking my blood glucose? u YES 10 u 15 NO 20 grams

16a Joe has type 1 diabetes and uses a 4 dose regimen 3 rapidly acting [Humalog] injections and 1 intermediate-acting [NPH] injection at bedtime His fasting blood glucose is usually in an acceptable range Last night he increased his usual dose of intermediate-acting insulin with 2 more units, and yet this morning his blood glucose is 300 mg/dL 167 mmol/L What should he do? i u ii u iii u iv u Increase his morning rapidly acting insulin Increase his morning rapidly acting insulin and his bedtime intermediate-acting insulin Increase his morning rapidly acting insulin to reduce his blood glucose and re-sample his blood glucose at 03:00 am the following night
Other give your own answer _______________________________________________ _

16b Last night Joe did not have dinner and did not take his bedtime insulin injection This morning he has a blood glucose level of 400 mg/dL 222 mmol/L and ketone bodies in his urine i u ii u iii u iv u This is because he could not sleep during the night insomnia and stress Insulin has accumulated in his body There is another explanation apart from food Other give your own answer _____________________________________________ _

16c Joes normal blood glucose is always 250 mg/dL 138 mmol/L before breakfast and 120 mg/dL 67 mmol/L 2 hours after dinner What would you suggest to improve his blood glucose control? i u ii u iii u iv u Reduce the rapidly-acting insulin before dinner Increase the bedtime intermediate-acting insulin dose Increase the rapidly-acting insulin before breakfast Other give your own answer _____________________________________________ _

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16d Bob ate twice his usual amount of carbohydrate at dinner He had already injected his 10 units of rapidly acting Humalog insulin What should he do? i ii u iii u iv u u u Try to vomit Add one more rapidly-acting
Humalog insulin injection of 3 units more Increase his intermediate-acting NPH insulin dose at bedtime Other give your own answer _____________________________________________ _

16e My doctor asked me to check my blood glucose at 3:00 am Why? i ii u iii u He wants to know if I am a reliable person He has no real purpose Other give your own answer _____________________________________________ _

16f I had my usual intermediate-acting NPH injection at 11:00 pm If my blood glucose at 03:00 am is 120 mg/dL 67 mmol/L, what will happen next? i ii u iii u iv u u A hypoglycemic episode at approximately 05:00 am Nothing will happen Depends on the time course of my last insulin injection Other give your own answer ______________________________________________ _

16g This evening I will have my nephews birthday and I will eat more than usual What should I do? i ii u iii u iv u v u u Increase my rapidly-acting insulin before dinner Increase my intermediate-acting insulin at bedtime Do both the above Check my blood glucose at 03:00 am Take 2 injections of rapidly acting insulin: the first at 10:00 pm and the second at 06:00 am

APPENDIX 2: DIABETES EDUCATIONAL LESSONS–GENERAL QUESTIONNAIRE
L1 Todays date L2 Lesson number L3 Educational intervention L4 Phase of study L5 Teacher / Facilitator / Wizard Doctor / 1 Simulator AIDA 2 / _____ /_____ /_____ 3 4 5 6

Conventional teaching 1 2 Nurse

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L6 Do you feel more confident with the information you received today? Rank on the scale 0 5 not at all confident 0 1 2 3 6 5 very confident 4 5 6

L7 What areas do you feel have not been convered enough? _____________________________________________________________________________________ L8 How do you rank todays information? 0 SYSTEM AVAILABILITY The AIDA diabetes simulation software continues to be developed and upgraded The latest release of AIDA v43 can be downloaded, without charge, from http://www2aidaorg on the Internet The program runs on IBM PC or compatible 80386 / 80486 / Pentium based machines and requires approximately 3 Mb of hard disk storage space The software can also be used on Apple Macintosh computers running PC emulators such as Virtual PC or SoftWindows A fully Internet-based version of AIDA, called AIDA on-line, is also available for use free-of-charge at http://www2aida org/online on the Web People who wish to be
automatically informed about future updates and enhancements to the AIDA/AIDA online diabetes software range can subscribe for free to the AIDA diabetes simulator announcement list by sending a blank email note to: subscribe@2aidaorg Any readers who might be interested in collaborating by applying the randomized controlled trial protocol overviewed above in an evaluation of AIDA in their own units for clinician/specialist nurse/educator-led patient teaching sessions are invited to contact one of the authors Further information about the evaluation of AIDA for patient use can be found at http://www2aidaorg/evaluate on the Web FURTHER TOPICS If you would like to suggest further topics or Websites for future Diabetes Information Technology WebWatch columns, please email information–with a brief description of the site/suggestion–to Dr ED Lehmann: 0 5 not at all useful 1 2 3 6 5 very useful 4 5 6

info-www@2aidaorg please write Diabetes WebWatch in the subject line You can also fax information to: 503 218-0828, quoting Diabetes Information Technology WebWatch REFERENCES
1 Tatti P, Lehmann ED: A randomised-controlled clinical trial methodology for evaluating the teaching utility of
interactive educational diabetes simulators Diabetes Nutr Metab 2001;14:117 2 Hurter P, Travis L: Introductory Course for Insulin-Dependent Diabetics, 6th ed Frankfurt: Gerhards, 1991 3 Tatti P, Lehmann ED: Utility of the AIDA diabetes simulator as an interactive educational teaching tool for general practitioners primary care physicians Diabetes Technol Ther 2001;3:161168 4 The Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus N Engl J Med 1993;329:977 986 5 Lehmann ED: The Diabetes Control and Complications Trial DCCT: A role for computers in patient education? Diabetes Nutr Metab 1994;7:308316 6 Lehmann ED: Spontaneous comments from users of the AIDA interactive educational diabetes simulator Diabetes Educ 2000;26:633643 7 Fitzgerald JT, Davis WK, Connell CM, Hess GE, Funnell MM, Hiss RG: Development and validation of the Diabetes Care Profile Eval Health Prof 1996;19:208 230

Address reprint requests to: Eldon D Lehmann, MB, BS, BSc Academic Department of Radiology St Bartholomews Hospital London, EC1A 7BE United Kingdom
E-mail: info-www@2aidaorg Website: http://www2aidaorg/lehmann

Source:cholestech.com