the did is a new tool incorporating different functions ; it is a carbohydrate / insulin bolus calculator , an information technology device , and a telemedicine system based on the communication between a health care professional ( physician or dietitian ) and a patient via text messages .
it allows patients to manage a flexible diet and to calculate the matching insulin bolus at each meal .
in addition , it includes an algorithm for the calculation of basal insulin dose , based on the values of fasting blood glucose and the presence of hypoglycemic episodes . did consists of software to be installed in the patient 's mobile telephone and enables the phone to be used as a small computer to record the blood glucose values and dose of insulin injections in real time ; the system is also able to suggest the daily carbohydrate intake , summing the amount of carbohydrate consumed progressively ( fig .
1 ) . every patient can decide what to eat during the meal , choosing between all the foods listed in the software ; the quantification of the total calories and carbohydrate consumed is facilitated by a list of pictures showing the specific food and the amount ingested .
the carbohydrate - to - insulin ratio and the glycemic correction factor , identified and prescribed by the health care professional , together with other information already filled out in the did ( e.g. , physical activity , glycemic target , insulin dose , and specific events ) , allow it to automatically calculate and suggest the most appropriate insulin dose to be injected .
besides the collection of data on blood glucose measurements , carbohydrate intake , and insulin doses , the use of did is associated with regular feedback for the patient .
in fact , data stored in the mobile phone are periodically sent as short text messages and reviewed on the personal computer of the physician .
then , any new therapeutic and behavioral prescription can be sent from the computer to the mobile phone , improving the communication between patients and physician .
the did study was an open - label , international , multicenter , randomized ( 1:1 ) , parallel - group study , having the primary goal of evaluating whether the use of did could improve glycemic control ( a1c ) in a shorter time and more easily than the carbohydrate counting standard educational approach .
secondary end points were changes in fasting blood glucose ( fbg ) levels , body weight , lipid profile ( serum total cholesterol , hdl cholesterol , ldl cholesterol , and triglycerides ) , and blood pressure ; furthermore , safety - related problems ( frequency of hypoglycemic episodes and hospitalizations ) and differences in time dedicated to educational activities were taken into consideration .
finally , quality of life and patient treatment satisfaction were investigated in the subgroup of italian patients .
the study involved seven diabetes outpatient clinics : three in italy , two in england , and two in spain .
every center was asked to enroll 20 patients satisfying all of the following inclusion criteria : diagnosis of type 1 diabetes , age 18 years , no previous education on carbohydrate counting , and treatment with multiple daily injections of short - acting and long - acting insulin analogs or with continuous subcutaneous insulin infusion ; patients practiced self - monitoring of blood glucose at least three times a day . other important requirements in the selection of patients were adequate familiarity in the use of mobile phones , according to the physician judgment , and possession of a personal mobile phone card .
all of the patients were requested to give written informed consent to gain entrance to the study .
patients were excluded if they were being treated with nph insulin or soluble regular insulin , had an eating disorder , were pregnant , were unable to send or receive short text messages , were unable or unwilling to give informed consent , or had any other disease or condition that may interfere with compliance with the protocol or completion of the study .
eligible patients were randomly assigned to start the standard carbohydrate counting educational program or the did approach .
patients randomly assigned to the experimental group attended a course on the use of did lasting up to 2 weeks .
the course was provided as an outpatient program of three encounters with the physician and/or dietitian .
patients randomly assigned to the control group received the standard educational approach usually used in the center , lasting up to 3 months . before the start of the study , an investigators ' meeting was organized to establish some fundamental rules in the educational training and in the prescription of carbohydrate - to - insulin ratio and the correction factor . at study entry ( visit 0 ) , at 3 months ( visit 1 ) , and at 6 months ( visit 2 ) clinical information was collected on case report forms .
baseline information included sociodemographic ( age , sex , and highest level of school education reached ) and clinical characteristics ( diabetes duration , insulin therapy , presence and severity of diabetes complications , comorbidities , and concomitant treatments ) .
blood pressure , body weight , fbg , a1c , and lipid profile were measured at each visit .
additional information was collected at the end of the study , including the number of contacts between the patient and the diabetes specialist ( both short text messages and office visits ) and any serious hypoglycemic episode requiring medical intervention .
changes in the health - related quality of life were evaluated in the subgroup of italian patients , using generic ( sf-36 health survey [ sf-36 ] ) and diabetes - specific ( world health organization - diabetes treatment satisfaction questionnaire [ who - dtsq ] ) measures : 
 the sf-36 is one of the most widely used measures of health - related quality of life and consists of 36 items covering eight dimensions : physical functioning , role limitations caused by physical health problems , bodily pain , general health perception , vitality , social functioning , role limitations caused by emotional health problems , and mental health ( 13 ) .
these eight domains may be further aggregated into two summary measures : the physical component summary measure and the mental component summary measure ( 13 ) .
these aggregated scores are transformed to norm - based scores ( 50  10 mean  sd ) , with higher scores indicating more favorable physical functioning / psychological well - being .
the sf-36 has been used in large population studies and in many different clinical conditions , showing excellent psychometric properties ( 14 ) .
it has been translated and validated in several languages , including italian ( 15).the who - dtsq has been specifically designed to measure satisfaction with diabetes treatment regimens and is appropriate for patients with type 1 and type 2 diabetes ( 16 ) .
the instrument was originally developed to detect changes in satisfaction related to changes in treatment modalities , but it is also appropriate for comparing levels of satisfaction in subjects using different treatment regimens .
it is composed of eight items , six of which are summed in a single score ranging from 0 ( very dissatisfied ) to 36 ( very satisfied ) .
the remaining two items are treated individually and explore the perceived frequency of hyperglycemic and hypoglycemic episodes .
the who - dtsq has been validated in the italian language among type 1 and type 2 diabetic patients , showing adequate psychometric properties ( 17 ) .
the sf-36 is one of the most widely used measures of health - related quality of life and consists of 36 items covering eight dimensions : physical functioning , role limitations caused by physical health problems , bodily pain , general health perception , vitality , social functioning , role limitations caused by emotional health problems , and mental health ( 13 ) .
these eight domains may be further aggregated into two summary measures : the physical component summary measure and the mental component summary measure ( 13 ) .
these aggregated scores are transformed to norm - based scores ( 50  10 mean  sd ) , with higher scores indicating more favorable physical functioning / psychological well - being .
the sf-36 has been used in large population studies and in many different clinical conditions , showing excellent psychometric properties ( 14 ) .
it has been translated and validated in several languages , including italian ( 15 ) .
the who - dtsq has been specifically designed to measure satisfaction with diabetes treatment regimens and is appropriate for patients with type 1 and type 2 diabetes ( 16 ) .
the instrument was originally developed to detect changes in satisfaction related to changes in treatment modalities , but it is also appropriate for comparing levels of satisfaction in subjects using different treatment regimens .
it is composed of eight items , six of which are summed in a single score ranging from 0 ( very dissatisfied ) to 36 ( very satisfied ) .
the remaining two items are treated individually and explore the perceived frequency of hyperglycemic and hypoglycemic episodes .
the who - dtsq has been validated in the italian language among type 1 and type 2 diabetic patients , showing adequate psychometric properties ( 17 ) .
sample size was estimated by assuming a between - group mean difference of 0.5% in a1c levels after 3 months and an a1c sd of 1.0 ( as derived from the did pilot study ) . given these assumptions , 63 patients per group were needed to ensure a statistical power of 80% (  = 0.05 ) .
taking into account a dropout rate of 10% , 70 patients per group had to be enrolled .
analysis was based on all the patients randomized , according to the intention - to - treat principle . for patients lost to follow - up
the last information available was used , by means of the last observation carried forward approach .
comparison of a1c and other secondary end points between groups was performed after 3 and 6 months from randomization based on the mann - whitney u test .
within - group differences achieved after 3 and 6 months from randomization were evaluated using the wilcoxon signed - rank test . because it was hypothesized that the telemedicine approach could help in achieving the desired goals in a shorter period of time , between - groups mean differences at 3 and 6 months
the did is a new tool incorporating different functions ; it is a carbohydrate / insulin bolus calculator , an information technology device , and a telemedicine system based on the communication between a health care professional ( physician or dietitian ) and a patient via text messages .
it allows patients to manage a flexible diet and to calculate the matching insulin bolus at each meal .
in addition , it includes an algorithm for the calculation of basal insulin dose , based on the values of fasting blood glucose and the presence of hypoglycemic episodes . did consists of software to be installed in the patient 's mobile telephone and enables the phone to be used as a small computer to record the blood glucose values and dose of insulin injections in real time ; the system is also able to suggest the daily carbohydrate intake , summing the amount of carbohydrate consumed progressively ( fig .
1 ) . every patient can decide what to eat during the meal , choosing between all the foods listed in the software ; the quantification of the total calories and carbohydrate consumed is facilitated by a list of pictures showing the specific food and the amount ingested .
the carbohydrate - to - insulin ratio and the glycemic correction factor , identified and prescribed by the health care professional , together with other information already filled out in the did ( e.g. , physical activity , glycemic target , insulin dose , and specific events ) , allow it to automatically calculate and suggest the most appropriate insulin dose to be injected .
besides the collection of data on blood glucose measurements , carbohydrate intake , and insulin doses , the use of did is associated with regular feedback for the patient .
in fact , data stored in the mobile phone are periodically sent as short text messages and reviewed on the personal computer of the physician .
then , any new therapeutic and behavioral prescription can be sent from the computer to the mobile phone , improving the communication between patients and physician .
the did study was an open - label , international , multicenter , randomized ( 1:1 ) , parallel - group study , having the primary goal of evaluating whether the use of did could improve glycemic control ( a1c ) in a shorter time and more easily than the carbohydrate counting standard educational approach .
secondary end points were changes in fasting blood glucose ( fbg ) levels , body weight , lipid profile ( serum total cholesterol , hdl cholesterol , ldl cholesterol , and triglycerides ) , and blood pressure ; furthermore , safety - related problems ( frequency of hypoglycemic episodes and hospitalizations ) and differences in time dedicated to educational activities were taken into consideration .
finally , quality of life and patient treatment satisfaction were investigated in the subgroup of italian patients .
the study involved seven diabetes outpatient clinics : three in italy , two in england , and two in spain .
every center was asked to enroll 20 patients satisfying all of the following inclusion criteria : diagnosis of type 1 diabetes , age 18 years , no previous education on carbohydrate counting , and treatment with multiple daily injections of short - acting and long - acting insulin analogs or with continuous subcutaneous insulin infusion ; patients practiced self - monitoring of blood glucose at least three times a day .
other important requirements in the selection of patients were adequate familiarity in the use of mobile phones , according to the physician judgment , and possession of a personal mobile phone card .
all of the patients were requested to give written informed consent to gain entrance to the study .
patients were excluded if they were being treated with nph insulin or soluble regular insulin , had an eating disorder , were pregnant , were unable to send or receive short text messages , were unable or unwilling to give informed consent , or had any other disease or condition that may interfere with compliance with the protocol or completion of the study .
eligible patients were randomly assigned to start the standard carbohydrate counting educational program or the did approach .
random lists were stratified by center . to ensure equal allocation rates within centers , permuted block randomization was used .
patients randomly assigned to the experimental group attended a course on the use of did lasting up to 2 weeks .
the course was provided as an outpatient program of three encounters with the physician and/or dietitian .
patients randomly assigned to the control group received the standard educational approach usually used in the center , lasting up to 3 months . before the start of the study , an investigators ' meeting was organized to establish some fundamental rules in the educational training and in the prescription of carbohydrate - to - insulin ratio and the correction factor .
at study entry ( visit 0 ) , at 3 months ( visit 1 ) , and at 6 months ( visit 2 ) clinical information was collected on case report forms .
baseline information included sociodemographic ( age , sex , and highest level of school education reached ) and clinical characteristics ( diabetes duration , insulin therapy , presence and severity of diabetes complications , comorbidities , and concomitant treatments ) .
blood pressure , body weight , fbg , a1c , and lipid profile were measured at each visit .
additional information was collected at the end of the study , including the number of contacts between the patient and the diabetes specialist ( both short text messages and office visits ) and any serious hypoglycemic episode requiring medical intervention .
changes in the health - related quality of life were evaluated in the subgroup of italian patients , using generic ( sf-36 health survey [ sf-36 ] ) and diabetes - specific ( world health organization - diabetes treatment satisfaction questionnaire [ who - dtsq ] ) measures : 
 the sf-36 is one of the most widely used measures of health - related quality of life and consists of 36 items covering eight dimensions : physical functioning , role limitations caused by physical health problems , bodily pain , general health perception , vitality , social functioning , role limitations caused by emotional health problems , and mental health ( 13 ) .
these eight domains may be further aggregated into two summary measures : the physical component summary measure and the mental component summary measure ( 13 ) .
these aggregated scores are transformed to norm - based scores ( 50  10 mean  sd ) , with higher scores indicating more favorable physical functioning / psychological well - being .
the sf-36 has been used in large population studies and in many different clinical conditions , showing excellent psychometric properties ( 14 ) .
it has been translated and validated in several languages , including italian ( 15).the who - dtsq has been specifically designed to measure satisfaction with diabetes treatment regimens and is appropriate for patients with type 1 and type 2 diabetes ( 16 ) .
the instrument was originally developed to detect changes in satisfaction related to changes in treatment modalities , but it is also appropriate for comparing levels of satisfaction in subjects using different treatment regimens .
it is composed of eight items , six of which are summed in a single score ranging from 0 ( very dissatisfied ) to 36 ( very satisfied ) .
the remaining two items are treated individually and explore the perceived frequency of hyperglycemic and hypoglycemic episodes .
the who - dtsq has been validated in the italian language among type 1 and type 2 diabetic patients , showing adequate psychometric properties ( 17 ) .
the sf-36 is one of the most widely used measures of health - related quality of life and consists of 36 items covering eight dimensions : physical functioning , role limitations caused by physical health problems , bodily pain , general health perception , vitality , social functioning , role limitations caused by emotional health problems , and mental health ( 13 ) .
these eight domains may be further aggregated into two summary measures : the physical component summary measure and the mental component summary measure ( 13 ) .
these aggregated scores are transformed to norm - based scores ( 50  10 mean  sd ) , with higher scores indicating more favorable physical functioning / psychological well - being .
the sf-36 has been used in large population studies and in many different clinical conditions , showing excellent psychometric properties ( 14 ) .
it has been translated and validated in several languages , including italian ( 15 ) .
the who - dtsq has been specifically designed to measure satisfaction with diabetes treatment regimens and is appropriate for patients with type 1 and type 2 diabetes ( 16 ) .
the instrument was originally developed to detect changes in satisfaction related to changes in treatment modalities , but it is also appropriate for comparing levels of satisfaction in subjects using different treatment regimens .
it is composed of eight items , six of which are summed in a single score ranging from 0 ( very dissatisfied ) to 36 ( very satisfied ) .
the remaining two items are treated individually and explore the perceived frequency of hyperglycemic and hypoglycemic episodes .
the who - dtsq has been validated in the italian language among type 1 and type 2 diabetic patients , showing adequate psychometric properties ( 17 ) .
sample size was estimated by assuming a between - group mean difference of 0.5% in a1c levels after 3 months and an a1c sd of 1.0 ( as derived from the did pilot study ) . given these assumptions , 63 patients per group were needed to ensure a statistical power of 80% (  = 0.05 ) .
taking into account a dropout rate of 10% , 70 patients per group had to be enrolled .
analysis was based on all the patients randomized , according to the intention - to - treat principle . for patients lost to follow - up
the last information available was used , by means of the last observation carried forward approach .
comparison of a1c and other secondary end points between groups was performed after 3 and 6 months from randomization based on the mann - whitney u test .
within - group differences achieved after 3 and 6 months from randomization were evaluated using the wilcoxon signed - rank test . because it was hypothesized that the telemedicine approach could help in achieving the desired goals in a shorter period of time , between - groups mean differences at 3 and 6 months
1 ) . fewer patients than those scheduled ( 130 vs. 140 ) were involved , as a result of organizational problems in two centers . however , because results show a sd of a1c of 0.76% and the dropout rate was 8.5% , the a posteriori study power to detect a difference between groups of 0.5% in a1c levels was 95% .
the study also had a statistical power of 80% to detect a between - groups difference in a1c levels of 0.38% .
the two groups did not differ for any sociodemographic and clinical characteristic , with the exception of slightly higher levels of triglycerides in the did group .
patients in the did arm also had a higher prevalence of retinopathy and symptomatic neuropathy , although statistical significance was not reached .
patients ' characteristics according to the randomization arm data are means  sd or frequency . *
p values refer to the  test for categorical variables or the mann - whitney u test for continuous variables .
overall , 11 patients dropped out during the study , 2 in the standard group and 9 in the did group ( fig .
2 patients found it difficult to use the did system , 4 had difficulties in sending text messages because of poor mobile network coverage in their area , 2 were not compliant with visit scheduling , and 1 moved to another area . between- and within - group changes after 3 and 6 months are shown in table 2 .
between- and within - group differences in clinical parameters and quality - of - life scores at visit 1 and visit 2 with respect to baseline values data are means  sd .
3 months and 6 months columns show the mean variation at visit 1 and visit 2 with respect to baseline ( 0 ) values .
questionnaires were administered to a subgroup of 60 patients ( 30 in the did group and 30 in the standard group ) .
a significant reduction in a1c levels of 0.5% was documented in both groups after 3 months and maintained until the end of study .
this improvement in metabolic control was obtained by devoting to carbohydrate counting education a median ( range ) of 6 ( 215 ) h in the did group and 12 ( 2.525 ) h in the standard group ( p = 0.07 ) .
furthermore , after 6 months there was a nonsignificant decrease in fbg in the did group ( from 182.8  85.6 to 162.9  67.0 mg / dl ) and a nonsignificant increase in the standard group ( from 176.9  68.4 to 186.3  79.1 mg / dl ) ( between - groups p = 0.13 ) .
the increase in body weight was lower in the did group ( 0.7  3.6 kg ) than in the standard group ( 1.5  2.3 kg ) , but the difference was not statistically significant ( p = 0.22 ) .
furthermore , although we found no differences in mean daily doses of short - acting insulin between the two groups ( did group 20.6  8.2 iu / day and standard group 20.1  7.8 iu / day ; p = 0.92 ) , mean daily doses of long - acting insulin were lower in the did group than in the standard group , although statistical significance was not reached ( did group 17.4  7.4 iu / day and standard group 21.4  10.0 iu / day ; p = 0.12 ) .
the did group showed a significant decrease in triglyceride levels in comparison with the standard group ; no other between - groups changes were documented .
the did group generally showed a tendency toward a small , not significant improvement in all the measures considered , whereas in the standard group all parameters , except diastolic blood pressure and hdl cholesterol , tended to slightly increase at the end of the study .
no patients in either group were admitted to the hospital during the study , and none reported any severe hypoglycemic episode requiring assistance . in each group , two patients reported episodes of mild hypoglycemia ( p = 0.93 ) .
the median ( range ) number of text messages sent by each patient during the study was 52 ( 675 ) , whereas the number of text messages sent by the physician was 39 ( 2270 ) .
in other words , patients sent about 2 text messages / week to their physician , and the physician regularly replied to confirm the therapeutic scheme or to modify the parameters set in the did ( carbohydrate - to - insulin ratio , insulin sensitivity factor , and/or blood glucose target ) . in terms of costs for the patient , assuming a cost of 1015  cents per message , and considering that on average each patient sent 52 messages , the overall cost sustained did not exceed  8 . results of quality of life evaluation performed on the subsample of 60 patients enrolled in the italian centers are shown in table 2 .
a statistically significant difference in favor of the did group was documented for treatment satisfaction , as expressed by the who - dtsq score .
similarly , the score testing the perceived frequency of hyperglycemic episodes significantly decreased after 3 months in the did group but not in the control group .
several sf-36 subscales ( role physical , general health , vitality , and role emotional ) also showed significantly higher improvements in the did group than in the standard group .
in addition , pre to post  within - group comparisons underlined the beneficial effects of did in the experimental group in terms of who - dstq - score , perceived frequency of hyperglycemic episodes , general health perception , and vitality ; on the other hand , all scores within the standard group tended to worsen at 3 months , although statistical significance was not reached .
the complexity of the educational approach needed to teach carbohydrate counting and consequent insulin adjustment can represent an obstacle for many patients , thus limiting the possibility of its widespread use as an effective self - management tool .
the carbohydrate / insulin bolus calculator is coupled with a telemedicine system based on short text messages . at the present time
, the most common way of data communication between patient and diabetologist is represented by the paper diary , which is often perceived as a boring document not adequately filled in ; furthermore , even if it is sufficiently complete , it can not facilitate a day - by - day adjustment of the insulin dose and lifestyle ( 18 ) .
in contrast , did is installed on the mobile phone , which is a familiar device already used in daily life by the majority of individuals . did facilitates not only the automatic storage of blood glucose measurements , carbohydrate intake , and insulin doses but also the exchange of information between patient and care provider via text messages . in this respect , although previous , small studies have evaluated the efficacy of telemedicine systems based mainly on the transmission of self - monitoring of blood glucose values and feedback from the health care provider ( 10 ) , this is , to our knowledge , the first study investigating a multipurpose instrument , replacing the classic approach to insulin dose modification .
our data show that did can represent a useful device , incorporating several features helping patients promote dietary freedom and flexible insulin bolus .
the first pilot study previously showed that the system is safe , easy to use , and well accepted by the vast majority of patients .
what these new results add is that the use of did is at least as effective as the traditional educational approach to carbohydrate counting in reducing a1c levels , while producing different concomitant benefits .
first , it allowed patients to avoid the complexities of carbohydrate counting and insulin dose adjustment with a halving in the time dedicated to education and thus potentially increasing the proportion of individuals with type 1 diabetes adopting this method . of note , despite the higher rate of dropouts in the did group , only two patients interrupted the study because of difficulties in using the telecare system , thus confirming that the device can be easily used by the majority of patients .
second , the use of did was associated with lower weight gain , probably because of the requirement of lower doses of long - acting insulin .
it is worth mentioning that , despite the use of lower doses of long - acting insulin , patients assigned to the did group showed a reduction in fpg levels during the study , whereas levels slightly increased in the control group .
this finding is important in light of the need to adopt therapeutic strategies that achieve good metabolic control while minimizing insulin dosage .
third , the use of did was also associated with a significant improvement in several mental and physical components of the sf-36 health survey , compared with the standard group .
this also translated into a marked improvement in treatment satisfaction , thus suggesting that the use of telemedicine can increase the level of acceptance of insulin treatment and help patients cope with the disease
first , we were not able to measure the effect of did in reducing glucose variability .
in fact , by allowing greater flexibility , one can speculate that telemedicine produced positive effects on postprandial blood glucose excursions also .
second , even if specific guidelines were established in the prestudy investigators ' meeting , the did educational intervention was influenced by the individual practice of the different international participating centers , thus varying in duration .
nevertheless , the randomization was stratified by center , making the comparison between telemedicine and usual care unbiased . in summary , did was at least as effective as traditional carbohydrate counting education , allowing dietary freedom to a larger proportion of type 1 diabetic patients . did
larger studies are needed to reach more solid conclusions regarding the effects of did on fbg , body weight , and insulin dosage .
 objectivewidespread use of carbohydrate counting is limited by its complex education . in this study 
 we compared a diabetes interactive diary ( did ) with standard carbohydrate counting in terms of metabolic and weight control , time required for education , quality of life , and treatment satisfaction.research design and methodsadults with type 1 diabetes were randomly assigned to did ( group a , n = 67 ) or standard education ( group b , n = 63 ) and followed for 6 months . 
 a subgroup also completed the sf-36 health survey ( sf-36 ) and world health organization - diabetes treatment satisfaction questionnaire ( who - dtsq ) at each visit.resultsof 130 patients ( aged 35.7  9.4 years ; diabetes duration 16.5  10.5 years ) , 11 dropped out . 
 time for education was 6 h ( range 215 h ) in group a and 12 h ( 2.525 h ) in group b ( p = 0.07 ) . 
 a1c reduction was similar in both groups ( group a from 8.2  0.8 to 7.8  0.8% and group b from 8.4  0.7 to 7.9  1.1% ; p = 0.68 ) . 
 nonsignificant differences in favor of group a were documented for fasting blood glucose and body weight . 
 no severe hypoglycemic episode occurred . 
 who - dtsq scores increased significantly more in group a ( from 26.7  4.4 to 30.3  4.5 ) than in group b ( from 27.5  4.8 to 28.6  5.1 ) ( p = 0.04 ) . 
 role physical , general health , vitality , and role emotional sf-36 scores improved significantly more in group a than in group b.conclusionsdid is at least as effective as traditional carbohydrate counting education , allowing dietary freedom for a larger proportion of type 1 diabetic patients . did is safe , requires less time for education , and is associated with lower weight gain . 
 did significantly improved treatment satisfaction and several quality - of - life dimensions . 