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Telemedicine is often suggested as a promising approach to support patients with diabetes. However, the effectiveness of diabetes-related telemedicine interventions in regard to patient-related outcomes requires further evaluation. Previous systematic reviews describing the effectiveness of telemedicine in diabetes management focus on a specific type of telemedicine, a specific type of diabetes, specific comparators, or specific outcomes. Moreover, the rapid development within telemedicine emphasizes the need for a new review.
The present review has a broad scope with an eye to performing an updated and exhaustive review within the field. The review aims to evaluate the effectiveness of existing telemedicine solutions versus any comparator without the use of telemedicine on diabetes-related outcomes among adult patients with diabetes.
The review will consider studies that include adult subjects with a diagnosis of diabetes (type 1, 2, or gestational), studies that evaluate various types of telemedicine interventions, and randomized controlled trials comparing a telemedicine intervention to any control that does not include telemedicine. Peer-reviewed full-text papers in English, Norwegian, Danish, and Swedish will be considered. A thorough search will be performed in the PubMed, CINAHL, EMBASE, and Cochrane Library Central Register of Controlled Trials (CENTRAL) databases. Data extraction will include details about the populations, study methods, interventions, and outcomes of significance based on the review objective.
The results of the review are expected to provide an estimate of the treatment effect. The studies will be pooled via statistical meta-analysis and supplemented with narrative comparisons when necessary.
The review is important as it will inform clinicians and investigators about the effect of various telemedicine solutions within the field of diabetes.
DERR1-10.2196/22062
Diabetes poses a major health care problem worldwide. In 2017, an estimated 8.4% of the adult world population had diabetes, and this number is predicted to increase to approximately 9.9% (425 million) in 2045 due to an increase in unhealthy dietary habits, overweight, physical inactivity, and other risk factors [
T1D and T2D are associated with premature death and several complications such as cardiovascular disease, nephropathy, neuropathy, and retinopathy [
Self-management support in the management of diabetes is a recognized approach to help people with diabetes navigate unavoidable decisions and activities related to the disease, and is known to be associated with improvements in health-related outcomes [
Telemedicine has been suggested as a promising but unproven approach to support people with diabetes in the control of their disease [
Previous systematic reviews describing the effectiveness of telemedicine for the management of diabetes exist [
The above-mentioned considerations suggest the value of a new and extensive review in the field. Therefore, the objective of this systematic review and meta-analysis will be to evaluate the effectiveness of existing telemedicine solutions versus any comparator without the use of telemedicine on diabetes-related outcomes among adult patients with diabetes. Telemedicine is defined as telecommunication and information technology that delivers health care services at a distance [
The review will be conducted and reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines [
The question of this systematic review and meta-analysis is as follows: How effective are telemedicine solutions versus any comparator without the use of telemedicine in regard to diabetes-related outcomes among adult patients with diabetes?
As the question indicates, the review has a very broad scope. Hence, the review considers (1) studies related to T1D, T2D, and GDM; (2) all patient-related outcomes (physiological/clinical, psychological, and behavioral); and (3) any comparator that does not include telemedicine.
This systematic review and meta-analysis will consider studies that included adults ≥18 years of age who were diagnosed with T1D, T2D, or GDM. Studies that focused on pregnant women with preexisting T1D or T2D will also be considered. Studies reporting mixed disease populations (eg, diabetes and heart disease), mixed diabetes types, or mixed age groups (children and adults) will be included if the data for the population with diabetes or adult age group are reported separately in a transparent subgroup analysis. Studies will be excluded if they only include subjects at risk of diabetes or individuals with prediabetes.
This systematic review and meta-analysis will consider studies that evaluate telemedicine interventions as a substitute or alternative to usual practice (ie, interventions with remote feedback/communication between either the patient and health care professional[s] or between the patient and trained peer[s]). Furthermore, wholly automatic telemedicine interventions will be considered. The telemedicine interventions may include various technologies such as telephone, smartphone, mobile phone, fax, text messaging, tablet, personal digital assistant, computer, and monitoring equipment (eg, glucometer, weight scale, pedometer, or sphygmomanometer) [
This systematic review and meta-analysis will consider studies that compare the intervention to usual care or an alternative intervention without telemedicine. Both parallel and crossover designs will be considered.
This systematic review and meta-analysis will consider studies that report on any patient diabetes-related outcome(s) (ie, any physiological, psychological, or behavioral outcome). The primary outcome for T1D and T2D will be glycemic control, measured as a change in glycated hemoglobin (%). The primary outcome for pregnancy-related diabetes will be birth weight.
This systematic review and meta-analysis will only consider randomized clinical trials (RCTs) with both a parallel and crossover design. Furthermore, studies will be included if the researchers consider the study to have adopted an RCT design based on the methodological approach of the individual study even if is the paper states that it used another design (eg, a quasiexperimental study design). Studies published in English, Danish, Norwegian, and Swedish as peer-reviewed full-text papers will be included. All studies published before the submission of the paper will be included, as both older and newer interventions are considered to bring value to the study (an updated search will be performed prior to submission).
The search strategy aims to locate both published and unpublished studies. An initial limited search of the PubMed and CINAHL databases will be undertaken to identify articles on the topic. The text words contained in the titles and abstracts of relevant articles and the index terms used to describe the articles will be used to perform a full search using PubMed, EMBASE, CINAHL, and the Cochrane Library Central Register of Controlled Trials (CENTRAL) databases. The full search history in PubMed is provided in
To prevent selection bias, a follow-up search will be performed in each of the four databases prior to manuscript submission.
Citation searches and manual searches of the reference lists of relevant systematic reviews and of all studies selected for critical appraisal will be performed to identify additional studies.
The databases to be searched are PubMed (no limitation of search years), EMBASE (no limitation of search years), CENTRAL (no limitation of search years), and CINAHL (no limitation of search years). Two review authors will perform the database searches in collaboration with a research librarian.
Citation searches will be performed in SCOPUS, Web of Science, and through Google Scholar. ClinicalTrials will be searched to identify unpublished studies.
Authors of identified articles will be contacted if an article is not possible to access or if any question occurs during the selection or extraction processes.
Following the search, all identified citations will be collated and uploaded into RefWorks (Refworks, RefWorks-COS, ProQuest RefWorks 2.0, 2010), where the functions
Reasons for exclusion of full-text studies that do not meet the inclusion criteria will be recorded and reported in the systematic review and meta-analysis. The results of the search will be reported in full in the final systematic review and meta-analysis, and presented in a PRISMA flow chart as shown in
The risk of bias assessment of eligible studies will be performed by two or more independent reviewers using the revised Cochrane risk-of-bias tool [
Authors of papers will be contacted to request missing or additional data for clarification when required. Any disagreements that arise between the reviewers will be resolved through discussion or with a third or additional reviewer(s). The results of the risk-of-bias assessment of the eligible studies will be reported in a risk-of-bias chart using the revised Cochrane risk-of-bias tool [
All studies, regardless of the results of their methodological quality, will undergo data extraction and synthesis (where possible).
Data will be extracted from the studies included in the review by three independent reviewers using tables in Microsoft Excel 2016. The data extracted will include specific details about the populations, study methods, interventions, and outcomes of significance based on the review objective. More specifically, three categories are considered relevant: (1) baseline characteristics of the study populations, (2) trial characteristics and key results, and (3) characteristics of the telemedicine interventions.
Any disagreements that arise between the reviewers will be resolved through discussion or with a third or additional reviewer(s).
All included studies will be pooled via a statistical meta-analysis to provide an overall estimate of the treatment effect. Meta-analyses will be performed with the RevMan VX.X (Copenhagen: The Nordic Cochrane Centre, Cochrane) software tool for T1D and GDM, and with Stata 14 software (StataCorp 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP) for T2D. Effect sizes will be expressed as relative risks for dichotomous data. For continuous outcomes, effect sizes will be expressed as the mean (SD) change in outcomes from baseline to follow up for both groups, and, if not available, the absolute mean (SD) at follow up for both groups will be used. From this, the mean difference between the intervention and control group (or standardized mean difference) and confidence intervals can be calculated for each study. Heterogeneity will be assessed qualitatively by comparing the characteristics of the studies and statistically using I2 tests. Statistical analyses will be performed using a fixed-effects model except if heterogeneity is deemed as being present (I2>50%), in which case a random-effects model will be used. Subgroup analyses on types of telemedicine will be conducted when appropriate. Where statistical pooling is not possible, the findings will be presented in narrative form, including tables and figures to aid in data presentation when appropriate. A funnel plot will be generated to assess publication bias if there are 10 or more studies included in a meta-analysis. Statistical tests for funnel plot asymmetry (Egger test, Begg test, Harbord test) will be performed when appropriate.
Three systematic reviews and meta-analyses will be conducted to obtain the results: one report on studies related to diabetes during pregnancy, one report on T1D studies (not related to pregnancy), and one report on T2D studies (not related to pregnancy). This subdivision is considered relevant to ensure a clear and easily accessible report of the results. The flowchart of the search will be reported in each of the reviews as it appears in
The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for grading the certainty of evidence will be used, and a Summary of Findings (SoF) will be created using GRADEPro GDT 2015 (McMaster University, ON, Canada; developed by Evidence Prime, Inc) [
The systematic review is ongoing. A preliminary search in PubMed resulted in retrieval of 4813 records (
The review is expected to have strengths as well as limitations. On the one hand, the search of literature will be very inclusive and exhaustive, which is a strength. On the other hand, the review is expected to be limited by the lack of homogeneity between the included telemedicine studies, as telemedicine studies tend to differ in intervention type, inclusion criteria, technology, and other aspects. The comparison of studies is expected to be complicated due to this divergence.
Search strategy.
Study selection flowchart.
Central Register of Controlled Trials
gestational diabetes mellitus
Grading of Recommendations, Assessment, Development and Evaluation
Preferred Reporting Items for Systematic reviews and Meta-analyses
randomized clinical trial
Summary of Findings
type 1 diabetes
type 2 diabetes
The authors acknowledge the research librarian Conni Skrubbeltrang for providing competent assistance during the search for articles.
All authors contributed to the conception, design, analysis, and interpretation of data. SL drafted the article, and the remaining authors revised it critically for important intellectual content. All authors approved the final version of this protocol.
None declared.