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Vetenskaplig artikel som del i ST-utbildning. Det är en verksamhetsuppföljning utav användandet av digitala hjälpmedlen Diasend/Carelink. En webenkät som undersökte hur många som använder ett sådant hjälpmedel och till vad. Dessutom relaterat till det senaste HbA1c värdet.

 

Investigating the regular use of diabetes management systems in a pediatric cohort of T1DM 

ST-läkare Henning Karlsson, Barn och ungdomskliniken, Sundsvall, Region Västernorrland 

Abstract 

Background:

Recent technical advancements in diabetes aids include the entry of continuous sensor-based glucose monitoring (CGM). All children with insulin dependent diabetes mellitus (IDDM) in Sweden should be offered CGM. Data from the national diabetes registry in Sweden [5] shows that 94% of all patients are reported to use CGM. In our regional outpatient clinic for pediatric T1DM patients we promote the use of Diasend and Carelink, two online diabetes management tools, to collect and interpret the glycaemic data from the glucose sensors. We encourage the regular use of these tools. 

Method:

In this study the primary objective was to explore the prevalence of regular use and satisfaction of these diabetes management tools using a voluntary and anonymous web-based questionnaire. A secondary objective was to investigate if there is a correlation between regular use and glycaemic control. The initial number of subjects were 131 patients. 

Results:

Respondents: 90 out of 130. Out of 90 completed questionnaires, 81 patients claimed to be using Diasend and Carelink. 51 subjects were frequent users (more often than every three months). 74 subjects claimed to be partially or fully satisfied with the diabetes management tool. There was no difference in median HbA1c-value between subjects who use Diasend or Carelink to make insulin treatment adjustments and those who don’t. 

Discussion:

A majority of respondents use Diasend or Carelink, but there is room for improvement in frequency of use. Likewise, less than half of respondents use the tool to adjust insulin treatment. The percentage that is satisfied with the tool suggests there is room for educational efforts. 

 

 

Background 

The Swedish Association of Local Authorities and Regions (SKR) have published national clinical practice consensus guidelines for the treatment of Type 1 diabetes (T1DM) in children [1] which states that every patient should have an individualized treatment plan, and that pediatric diabetic care teams should aim for a mean HbA1c <48 mmol/mol, without any severe hypoglycemia. In the same document it is stated that all children with IDDM should have access to sensor-based blood glucose monitoring, known as (rtCGM) real time continuous glucose monitoring or (iCGM/FGM) intermittent/flash glucose monitoring. CGM is now cleared for non-adjunctive use, without parallel [2] self-monitored blood glucose (SMBG). With the help of the voluminous amounts of data from CGM/FGM it is now possible to characterize individual’s daily glycemic profile compared to HbA1c which changes slowly over months. 

The data from these new continuous glucose monitors have sprouted new treatment variables like TIR, time in range, and SD, standard deviation from the mean [3]. Pediatric diabetes care clinics in Sweden widely use the online platforms Diasend and Carelink to collect and share CGM and insulin pump data between patients and health care professionals. A small crossover study [4] of adult patients with T1DM treated with continuous subcutaneous insulin infusion (CSII) with SMBG showed that patients uploading SMBG data to a software tool (Accu-Chek SmartPix) significantly improved glycaemic control. 

Problem 

At this moment 94 % of patients in our clinic are prescribed rtGM/iCGM. When introducing rtCGM/iCGM to pediatric patients at our outpatient clinic we promote the use of the web-based tool Diasend or Carelink. We encourage the use of this web tool at home in between regular visits at the clinic. Tools include the ambulatory glucose profile, Time-in-Range, standard deviation, and summary of daily insulin dosage. 

At this moment there is no record of the number of patients or caregivers who routinely upload data and take advantage of the vast amounts of data that CGM provides. Can we improve the introduction to CGM at start-up? And perhaps to refresh basic CGM theory at certain intervals? 

Objective 

The purpose of this study is to investigate the prevalence of regular use and satisfaction of the diabetes management tool in our cohort of patients with T1DM at the pediatric outpatient clinic in Sundsvall and Härnösand. A secondary objective is to investigate if there is a correlation between regular use and glycaemic control, measured by self-reported latest HbA1c value. 

Method 

We collected data by letting all patients together with their caregivers answer a web-based questionnaire. There were three questions concerning age, number of years since diagnosis, treatment strategy and blood glucose monitoring device. Followed by three questions concerning the regular use of the Diasend/Carelink tool. Finally, we asked for their latest HbA1c value and for their opinion on the diabetes management tool. The HbA1c value was categorized into levels of 5, ranging from 40-90. See in questionnaire, question number 8. 

Questionnaire: 

  1. How old is your child? 
  2. How many years have passed since the debut of diabetes mellitus typ 1? 
    1. 3. What equipment does your child have? a. Injection treatment and blood glucose meter for self-checks. 
    2. b. Injection treatment and continuous glucose monitoring. 
    3. c. Insulin pump and blood glucose meter for self-checks. 
    4. d. Insulin pump and continuous glucose monitoring. 
    5. 4. Do you use Diasend or Carelink? Yes or No. 
    6. 5. We adjust insulin treatment using Diasend/Carelink. Yes or No. 
    7. 6. How often do you use Diasend or Carelink? a. Every or every other week. 
    8. b. Once a month. 
    9. c. About every three months. 
    10. d. Less than every three months. 
    11. e. Never. 
    1. To what extent do you agree with the following statement? We are satisfied with Diasend/Carelink. a. Fully disagree. 
    2. b. Partially disagree. 
    3. c. Undecided. 
    4. d. Partially agree. 
    5. e. Fully agree. 
    6. 8. My childs latest HbA1c was: a. <40 mmol/mol 
    7. b. 41-45 mmol/mol 
    8. c. 46-50 mmol/mol 
    9. d. 51-55 mmol/mol 
    10. e. 56-60 mmol/mol 
    11. f. 61-65 mmol/mol 
    12. g. 66-70 mmol/mol 
    13. h. 71-75 mmol/mol 
    14. i. 76-80 mmol/mol 
    15. j. 81-85 mmol/mol 
    16. k. 86-90 mmol/mol 
    17. l. >90 mmol/mol 
    18. Do not know. 
    19. Other comments: (voluntary) 

 

We sent out written information about the survey concerning method and objective the week before. A text message with the link to the web questionnaire was sent to one of their caregivers. Reminders were sent by text message after seven and fourteen days. The questionnaire was closed after three weeks. 

Mann-Whitney test was used to assess if differences in HbA1c between groups were significant. The significance level was set to 5%. The analysis has been done with IBM SPSS 26 (Armonk, NY: IBM Corp). There was no power analysis made as the main objective was a cross-sectional prevalence study and the whole population was included. 

90% of responders stated that they use the diabetes management tool Diasend or Carelink. But 46,7% claimed that they adjust insulin treatment using the tool. 56,7% use the diabetes management tool more often than every three months (table 2). Patients who claim to use the tool for adjustments in insulin treatment are more frequent users of the tool; every month compared to every three months (table 3). Nine of the subjects were newly diagnosed. Two out of nine claimed to make treatment decisions using the tool.

The median of HbA1c was 46-50 mmol/mol in patients who use a diabetes management tool and 51-55 mmol/mol in those who don’t, but the difference was not significant, p-value 0.64 (figure 1). There was no difference in median HbA1c value between those who adjust insulin treatment using Diasend or Carelink compared to those who don’t. Both groups reported the same median HbA1c of 46-50 mmol/mol, p-value 0,325 (figure 2). Figure 1: Do you use Diasend or Carelink? Yes/No. My child’s latest HbA1c value was. HbA1c Is graded from 0-11, each step represents the intervals in the study. Figure 2: We adjust insulin treatment using Diasend/Carelink. Yes/No. My child’s latest HbA1c value was. HbA1c Is graded from 0-11, each step represents the intervals in the study. 6 82,2% of responders fully or partially agree that they are satisfied with the tool (table 4), and the lowest proportion are found among patients with MIIR and no CGM. (table 5).

Claim: We are satisfied with Diasend/Carelink. Number and percentage of total Fully disagree 7 (7,8%) Partially disagree 2 (2,2%) Undecided 7 (7,8%) Partially agree 39 (43,3%) Fully agree 35 (38,9%) Total 90 (100%) Table 4: Degree of satisfaction, described as percentage of total among respondent. We are satisfied with Diasend or Carelink. MIIR + CGM/FGM MIIR + SMBG CSII + CGM/FGM CSII + SMBG Total Fully disagree 2 (11,8%) 2 (50,0%) 2 (3,2%) 1 (16,7%) 7 (7,8%) Partially disagree 2(3,2%) 2 (2,2%) Undecided 1 (5,9%) 1 (25,0%) 4 (6,3%) 1 (16,7%) 7 (7,8%) Partially agree 8 (47,1%) 29 (46,0%) 2 (33,3%) 39 (43,3%) Fully agree 6 (35,3%) 1 (25,0%) 26 (41,3%) 2 (33,3%) 35 (38,9%) Total 17 (100%) 4 (100%) 63 (100%) 6 (100%) 90 (100%)

Table 5: Degree of satisfaction, broken down by treatment method and method of glucose monitoring.

Discussion

Our study group differs from the population in the outpatient clinic and the national data only by a slightly lower median HbA1c-value. The median HbA1c value in the non-responders is probably higher. Respondents are not fully comparable to the total population neither regional nor national. The results show that a large majority, 90%, of our respondents are familiar with the diabetes management tool and that almost half of them use it to guide their insulin treatment decisions.

The true prevalence of diabetes management tool usage in our population is therefore unsure. It is positive for us to see that as many as 82% are fully or partially satisfied with the tool. This could mean that more patients and guardians can expand their use of the tool given increased educational efforts. Even though we couldn’t show an improved HbA1c value among the more frequent users of the tool we will continue to advocate the use of the diabetes management tools Diasend and Carelink. A future survey could explore other perceived benefits than an improved HbA1c value.

Conclusion

Fewer respondents than desired use the diabetes management tools fully. This study has highlighted an area of improvement. A majority of respondents are 7 satisfied with the diabetes management tool. There is no statistical relationship in our study between regular use and an improved glycaemic control.

Author contributions

Statistical calculations were performed by Erling Englund, statistician and PhD, Region Västernorrland. Marika Augutis, Research advisor and PhD, supported the author in study and essay design.

References

1. Barn med typ 1-diabetes NATIONELLT VÅRDPROGRAM FÖR BEHANDLING MED INSULINPUMP OCH KONTINUERLIG GLUKOSMÄTNING © Sveriges Kommuner och Landsting, 2018 Bestnr: 5465 Text: Nationella arbetsgruppen för diabetes Datum 2018-03-22

2. Edelman SV. Regulation Catches Up to Reality. J Diabetes Sci Technol. 2017;11(1):160–164. doi:10.1177/1932296816667749

3. Battelino T. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care Aug 2019, 42 (8) 1593-1603; doi: 10.2337/dci19-0028

4. Reichel, Andreas, et al. “Self-Adjustment of Insulin Dose Using Graphically Depicted Self-Monitoring of Blood Glucose Measurements in Patients with Type 1 Diabetes Mellitus.” Journal of Diabetes Science and Technology, vol. 7, no. 1, Jan. 2013, pp. 156–162, doi:10.1177/193229681300700119.

5. NDR Nationella Diabetesregistret, Knappen 2.0 [The National Diabetes Registry]. Date: 2020-05-23

 

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Results 

Out of 131 subjects initially included in the study there were 90 subjects who completed the questionnaire. Seven of them couldn’t give the latest HbA1c-value. The characteristics of the study group are described in table 1, and is compared to the patient group as a whole as described in the national diabetes register (NDR)[5]. The median HbA1c value for the study group was 46-50 mmol/mol, slightly lower than the T1DM population in our outpatient clinic [5]. Parameters 

Study group 

Sundsvall/Härnösand 

Sweden 

Mean age (years) 

12,4 

12,8 

12,3 

CSII* 

69/90 (76,7%) 

105/141 (74,5%) 

68,1% 

MIIR* 

21/90 (23,3%) 

36/141 (25,5%) 

31,9% 

rtCGM/iCGM 

80/90 (88,9%) 

132/141 (93,6%) 

96,4% 

HbA1c (mmol/mol) 

Median 46-50 

Mean 51,6 

Mean 53,3 

 

 

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