Clinical Experience of Using Telemedicine for the Management of Patients Using Continuous Subcutaneous Insulin Infusion in a Highly Complex Latin American Hospital

Round 1

Reviewer 1 Report (Previous Reviewer 1)

It is clear that the authors have improved the manuscript in this new version.
Despite the improvements, there remains some flaws the need to be addressed:

- The abstract still needs to be reworded. Conclusions are poor. Also in the results, the authors write "We included 36 patients who 23 had T1DM (20, 75%)", but in the text (and later in the abstract) the declare that there were T1DM and T2DM patients. Again, what is 20 and 75%? What is TAB?

- Statistics: considering the short number of patients and the fact that most variables seem to be not normally distributed, nonparametric tests should be preferred. Please, indicate the level of significance chosen for this study.

- Results: Table 2 and Table 3 should be better organized in terms of rows and columns and text as they look confusing; also be consistent, decimals are expressed after e dot (.), not after a comma (,). Also be consistent with the use of the sample size (e.g., in table 3 there is no n=... after overall)

- Discussion: although the authors state in the limitations that they did not look over the changes in terms of physical activity and diet, this should be discussed in the discussion as a potential factor affecting the findings, since there is literature suggesting that during COVID-19 lockdown many people (and people with diabetes) reduced their physical activity levels, and that physical activity often represent a challenge for many diabetic individuals that benefit from smart applications and systems to help them determine the need of CHO to avoid hypo and hyperglycemia.

Author Response

Santiago de Cali April 5th 2023

Dear Editors and reviewers

International Journal of Environmental Research and Public Health

Response to Reviewers

Reviewer 1:

• The abstract still needs to be reworded. Conclusions are poor. Also, in the results, the authors write "We included 36 patients who 23 had T1DM (20, 75%)", but in the text (and later in the abstract) the declare that there were T1DM and T2DM patients. Again, what is 20 and 75%? What is TAB?
  • Response: Thank you very much for your comments. The abstract has been rephrased accordingly. Indeed, there were some errors in the wording of the results section. There were a total of 36 patients, out of which 29 had type 1 diabetes mellitus and 7 had type 2 diabetes mellitus. Additionally, there was an error in the abbreviation used for Time Above Range (TAR), which was incorrectly stated as TAB. The necessary corrections have been made. lines 17-34 have been changed.

 

• Statistics: considering the short number of patients and the fact that most variables seem to be not normally distributed, nonparametric tests should be preferred. Please, indicate the level of significance chosen for this study.
  • Response: All quantitative variables were subjected to normality tests using the Shapiro-Wilk test. Here we present an example of normally distributed values for the following variables:

Mean sensor glucose concentration: Prob > Z: 0.896. Considering the statistical significance <0.05, it follows a normal distribution and is therefore presented as mean and standard deviation.

GMI: Prob > Z: 0.988. Considering the statistical significance <0.05, it follows a normal distribution and is therefore presented as mean and standard deviation.

Time 180-250 mg/dL %: Prob > Z: 0.663. Considering the statistical significance <0.05, it follows a normal distribution and is therefore presented as mean and standard deviation.

Therefore, all variables reported as means and standard deviations conform to the assessment of their respective normal distribution, as expressed above. Variables presented as medians and interquartile ranges do not follow a normal distribution according to a statistical significance of 0.05.

 

 

• Results: Table 2 and Table 3 should be better organized in terms of rows and columns and text as they look confusing; also be consistent, decimals are expressed after e dot (.), not after a comma (,). Also be consistent with the use of the sample size (e.g., in table 3 there is no n=... after overall)
  • Response: In tables 2 and 3, the format has been modified, including changes to the column and row structure. Additionally, all decimals have been expressed using a period (.) as the decimal separator. The population size (n) has also been added to all tables.

 

• Discussion: although the authors state in the limitations that they did not look over the changes in terms of physical activity and diet, this should be discussed in the discussion as a potential factor affecting the findings, since there is literature suggesting that during COVID-19 lockdown many people (and people with diabetes) reduced their physical activity levels, and that physical activity often represent a challenge for many diabetic individuals that benefit from smart applications and systems to help them determine the need of CHO to avoid hypo and hyperglycemia.

 

• Response: In the discussion section, it was discussed how exercise and diet should have been taken into account as confounding factors during the Covid-19 pandemic, and what measures should be taken.This was discussed in lines 200 to 2011 of the manuscript.

Reviewer 2 Report (New Reviewer)

Title: Clinical experience of the use of telemedicine for the management of patients using insulin pump in a High Complex Latin American Hospital Journal: International Journal of Environmental Research and Public Health

The article reports on a telemedicine experience during the SARS-COV2 pandemic. It reports on the follow-up of 36 people who were treated with different models of insulin pumps. The article is not new. In fact, when I read it, I did not see the added value of telemedicine in these 36 patients. In fact, the authors seem to describe in detail the value of insulin pumps and their ability to keep patients in good glycemic control. These patients are initially very well controlled in terms of their diabetes, according to the CGM parameters. I have not seen any other added value of telemedicine .... for this selected population, apart from the fact of remote monitoring.….

Major comments

There is an obvious bias as 109 patients were proposed for remote monitoring but only 36 accepted. The authors should first explain how they proposed telemedicine to the 109 patients followed and what are the inclusion and exclusion criteria for telemedicine follow-up that they proposed; then they should explain why they retained only 36. This is a fundamental element in knowing the barriers to the use of telemedicine.  Why do these 36 patients stay connected with hospital when they already have excellent blood glucose results!... The interest of telemedicine is therefore not in the care, but in the fact that patients do not have to travel (which is already an advantage)..

In addition, a failure of telemedicine should be noted in the hospitalisation of a patient with ketoacidosis during follow-up. The blood glucose level should have been very high for several days. Unfortunately, the authors do not explain the reasons for this failure. It would have been useful to describe this case in detail!

Finally, the authors congratulate themselves on the improvement of certain blood glucose levels. However, they don't explain why! Is this due to remote monitoring?

 

minor

Verification of some abbreviations such as GGI (GMI)

How did the authors get an HbA1c (biological)? Did the patients have to come back to the hospital ?

A comma 05% is missing on p 9 line 172 ?

In conclusion, this article should detail why and to whom the authors proposed telemedicine, detail a "timeline" of follow-up, how many contacts with their patient, finally, feedback from the patients would also have been very interesting;

Author Response

Santiago de Cali April 5th 2023

Dear Editors and reviewers

International Journal of Environmental Research and Public Health

Response to Reviewers

Reviewer 2:

Major comments

 

There is an obvious bias as 109 patients were proposed for remote monitoring but only 36 accepted. The authors should first explain how they proposed telemedicine to the 109 patients followed and what are the inclusion and exclusion criteria for telemedicine follow-up that they proposed; then they should explain why they retained only 36. This is a fundamental element in knowing the barriers to the use of telemedicine.  Why do these 36 patients stay connected with hospital when they already have excellent blood glucose results!... The interest of telemedicine is therefore not in the care, but in the fact that patients do not have to travel (which is already an advantage)..

• Response: All patients who met the inclusion criteria were voluntarily offered to participate in the study and only those who accepted were included. Our interest was to demonstrate that telemedicine maintains glycemic control in insulin pump diabetic patients avoiding displacement and maintaining social distancing.

 

in addition, a failure of telemedicine should be noted in the hospitalisation of a patient with ketoacidosis during follow-up. The blood glucose level should have been very high for several days. Unfortunately, the authors do not explain the reasons for this failure. It would have been useful to describe this case in detail!

• Response: Line 217. The patient who presented diabetic ketoacidosis was highlighted in the discussion, where it was mentioned that the precipitating factor for the ketoacidosis was a urinary tract infection with progression to sepsis, and it is known that despite adequate glycemic control, having diabetes is a risk factor for the development of complications due to its immunosuppressive role.

Finally, the authors congratulate themselves on the improvement of certain blood glucose levels. However, they don't explain why! Is this due to remote monitoring?

Response: The improvement in glucose levels could be due to both the training in the use of the insulin pump along with its appropriate use and the teleconsultation follow-up.

minor

Verification of some abbreviations such as GGI (GMI)

• Response: the abbreviation GMI was corrected in table 2.

How did the authors get an HbA1c (biological)? Did the patients have to come back to the hospital ?

• Response: The patients were required to go to the hospital to have their paraclinical tests done. Lines 70-71.

 

In conclusion, this article should detail why and to whom the authors proposed telemedicine, detail a "timeline" of follow-up, how many contacts with their patient, finally, feedback from the patients would also have been very interesting;

• Response:

The answer is found in the Materials and Methods section. All diabetic patients with a minimum diagnosis of one year, who had been using an insulin pump for at least three months, and had at least two appointments with an endocrinologist were invited to participate voluntarily in the study, and only 36 accepted. The follow-up was performed at least one month after accepting participation, and a minimum of two contacts were made per patient.

While the patient's opinion is acknowledged, however, it is difficult to make contact with patients after medical appointments, as patients change hospitals for follow-up due to administrative reasons from health promoting entities.

 

Round 2

Reviewer 1 Report (Previous Reviewer 1)

I am fine with the responses.
Thank you

Reviewer 2 Report (New Reviewer)

Thank you for your comments 

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.

Round 1

Reviewer 1 Report

This manuscript describes an important topic, which is T1DM management, and in becomes of particular importance when approached to peculiar conditions, as during isolation or reduced capacity to be followed by a clinician. In this, telemedicine and telehealth have become of great importance and offered several opportunities.
The manuscript presents several flaws in the way it is written and should be improved before being considered for publication.
I have some comments/suggestions:

 

- Overall, the english should be revised as several errors are present in text, already starting from the abstract (e.g., We included 36 patients 23 were T1DM were 20 (75%).

- Methods: More information is needed about the population. The authors should specify what inclusion criteria were used also in terms of the disease (e.g., participants had to be disgnosed with T1 or T2 diabetes mellitus from at least n years (e.g., it is important to exclude those within 1 year from the diagnosis), absence of certain comorbidities).

Also, they should also give much more information about the protocol, the outcomes, how they were collected and measured, etc.
It is too way too much poorly discussed.

Statistics are definetely not appropriate.

Based on this last point, it is not possible to judge neither the results nor the discussion.

Author Response

Dear Editors and reviewers
Response to Reviewers
International Journal of Environmental Research and Public Health
Comments and Suggestions for Authors: 
1. Overall, the english should be revised as several errors are present in text, already 
starting from the abstract (e.g., We included 36 patients 23 were T1DM were 20 (75%).
2. Methods: More information is needed about the population. The authors should specify 
what inclusion criteria were used also in terms of the disease (e.g., participants had to be 
disgnosed with T1 or T2 diabetes mellitus from at least n years (e.g., it is important to 
exclude those within 1 year from the diagnosis), absence of certain comorbidities).
3. Also, they should also give much more information about the protocol, the outcomes, 
how they were collected and measured, etc.
It is too way too much poorly discussed.
4. Statistics are definetely not appropriate.
Based on this last point, it is not possible to judge neither the results nor the discussion.
Response: 
1. 1. The article was submitted to a translation and certified grammatical revision.
2. 2. In the methods section, the information corresponding to the inclusion and 
exclusion criteria of the study population was expanded, for example, the following 
were mainly selected participants were over 18 years of age with type 1 and type 2 
diabetes, who had been diagnosed with diabetes for more than one year, had at 
least two controls by teleconsultation in the period mentioned using continuous 
glucose monitoring (CGM) more than 70% of the time, and also had failed previous 
medical treatment, i.e., their diabetes did not reach control goals despite multiple 
management with oral medication, they had to be adherent to their insulin 
management and use an insulin pump for at least 3 months. All participants 
received diabetes education from the diabetes team and a specialist educator. 
Participants used the Medtronic Paradigm Veo Enlite sensor, Medtronic MiniMed 
640G Enlite sensor and Medtronic Minimed 670G uses Guardian™ Sensor 3.
Participants excluded were patients with incomplete teleconsultation 
records, women who were pregnant or planning to become pregnant, patients in 
another clinical trial, patients with active malignancy, visual impairment, or any 
disability that affected their ability to use the insulin pump, and non-adherence to 
treatment
3. Telemedicine Program Overview
Patients completed at least 2 virtual consultations (initial and follow-up). Initially, 
patients received education from the diabetes team composed of a nutritionist, 
diabetes nurse and endocrinologist, where they were taught how to use the insulin 
pump, how to use the CareLink platform for recording glucose monitoring data and 
how to download glucose data.
The telemedicine follow-up was carried out using the Microsoft Teams platform. In 
the first teleconsultation, the physician verified clinical conditions, ongoing 
treatment and adherence to recommendations on healthy lifestyle changes. The 
recorded glycemia data was monitored and treatment changes were made as 
needed. At the second teleconsultation, which was performed at least after a 
minimum of 30 days, glycemic control and changes from the first consultation were 
measured. All the information collected during the teleconsultations was recorded 
in an electronic medical record.
4. The statistics have been corrected in the results section. 

Reviewer 2 Report

Very poor english writing. Very low scientific accuracy, badly written methods, results and discussion sections.

Author Response

The article was subjected to a translation and certified grammatical revision, the methods were corrected and the information of inclusion and exclusion criteria, the protocol of telemedicine attention, the units and the statistics in the results section were corrected.