Diabetes Mellitus, Type 2TTEDMV1NCT04932356
Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control
A study testing Therapeutic education by phone and Therapeutical education traditional in people with Diabetes Mellitus, Type 2, run by Mª Dolores Rodríguez Garrido at 1 site in Spain.
Trial summary
Diabetes Mellitus (DM) is one of the most prevalent chronic diseases worldwide and with a significant impact on health spending. The literature identifies that the telephone improves the process of clinical care and patient outcomes. Programs are known to have demonstrated improvements in HbA1c outcome in DM2. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Therapeutic education by phone and Therapeutical education traditional
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DM2 patient with HbA1c > of 8%
- With some form of drug medication for their diabetes.
Who cannot join
- persons with gestational diabetes,
- psychiatric disease
- hearing or vocalization problems,
- terminal patient in PADES,
- patient with chronic acute disease (MACA),
- the denial of participating in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
MªDolores Rodriguez
Viladecans, Barcelona, 08840
MªDolores Rodriguez, 630942759 ext. +34, lolirodriguezgarrido@gmail.com
DIANA ROMERO, 695438560 ext. +34, dromero@ambitcp.catsalut.net
About this study
Official title: To Evaluate the Impact of a Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control Over Glycosylated Hemoglobin and Spontaneous Nursing Visits, in a Primary Care Center
Diabetes Mellitus (DM) is one of the most prevalent chronic diseases worldwide and with a significant impact on health spending.
The literature identifies that the telephone improves the process of clinical care and patient outcomes. Programs are known to have demonstrated improvements in HbA1c outcome in DM2.
Read more
In the majority of patients their follow-up is carried out from primary care, where they occupy a third of the visits, it is a main reason for consultation.
The mobile phone is becoming an interesting tool for therapeutic education.
The objective: To decrease the HbA1c value by 10% in patients who have their HbA1c >9% and 0.5% in those who have an HbA1c value <9%-Reduce the number of spontaneous visits in nursing consultations.
Know the attitude and motivations of the patients participating in the study It will be a probabilistic randomized intervention study at the Mas Font Primary Care Center in Viladecans (Barcelona).
According to medical history as of December 31, 2020, there were 1554 patients diagnosed with DM2, 402 DM2 patients with poor control (HbA1c >8%) Patients who meet inclusion criteria will be contacted by telephone or at consultations and will be offered to participate and sign consent.
They are then automatically randomized to intervention or control group. Study participants will be visited in person every six months and both groups will follow the center's protocol in face-to-face visits, The intervention group will be reinforced with a fortnightly telephone visit.
Read the detailed description
The study is of the probabilistic random intervention type, in a Primary Care center. The area where the study will be carried out: Population attached to ABS Mas Font over 18 years (18,431 people), in Viladecans (Barcelona). In the computerized medical history database, as of December 31, 2020, 1554 patients diagnosed with DM2 were found. By 2020 they had two HBa1cs registered in 402 patients (26% of all PATIENTS with DM2), only 711 (45.75%) 441 (28.4%) no. With one of the last two > 8 there are 145 patients. With the last two values > 8 there are 87 patients. Socio-economic data Typology according to CatSalut - Urban population with medium-high privacy MEDEA* ABS Viladecans Index 1 x 0'70 (Median of Catalonia 0'44) *It is a deprivation rate based on the following socio-economic indicators: manual workers, unemployment, eventual employees, total under-education and in 18 young people. Inclusion and exclusion criteria the denial of participating in the study. Sample calculation In the computerized medical history database, as of December 31, 2020, 1554 patients diagnosed with DM2 were consisting of 402 DM2 patients (26%) have at least two records of HbA1c. Accepting an alpha risk of 5%, beta less than 20%, in a unilateral contrast and waiting to detect a minimum difference of 0.9, for a deviation of 1.2 in HBa1c values and with losses not greater than 10%, 32 patients are required in each group. The sample should be increased by 20% in case there were drop outs, requiring a sample of 38 patients in each group to be able to find a difference in HbA1c. (IMIM GRANMO https://www.imim.es/ofertadeserveis/software-public/granmo/) Source of subjects From the list of patients who meet criteria you will get a sample Random. The collected patients will be contacted by telephone or at the consultations and offered to participate in the study. The purpose of the same will be explained and the confidentiality of the data will be ensured. If they agree to participate they will be summoned to the center where they sign the informed consent (see attached document). They are then automatically randomized to intervention or control group. Definition of variables Demographic:
-age: in Limitations and possible biases One limitation that we can find is that the data on the follow-up of the medication varies, since during a year the patient can change treatment, due to hospital admission (variable that will be collected in both groups and a stratified analysis will be performed if necessary).
The loss of follow-up of patients due to different causes (such as patients who can change cities during vacation periods and difficult telephone locations due to difficulties in coverage, changes of residence). The final impact of the study and the reason for the losses will be evaluated.
Lack of feedback between the patient and the nurse
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Therapeutic education by phone, Therapeutical education traditional
- Keywords
- Educational Technology, Diabetes Mellitus Type 2, Glycated Hemoglobin A, Pragmatic Clinical Trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic education by phoneOther
The patients who participate in the intervention group, after their face-to-face visit, will undergo a fortnightly reinforcement by telephone of diabetes education (review of diet, physical exercise, doubts about insulin or oral medication and the registry of blood glucose controls). In addition, emotional support will be provided to the patient, along with a semester calendar with scheduled calls to carry out the intervention, at a specific time.
Therapeutical education traditionalOther
The patients participating in the study will be visited in person every six months where the control group will follow the usual protocol of the health center in the face-to-face visits, with their respective analyzes and pertinent tests, together with health education and adherence to pharmacological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Education by phone | Other | Therapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit and then reinforcement each 15 days over the weak points of this visit. Receives: Other: Therapeutic education by phone |
| Traditional Therapeutic Education | Other | Therapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit. Receives: Other: Therapeutical education traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Result
Descriptive statistics of the variables will be carried out, using measures of central tendency and dispersion for quantitative variables and percentages with a 95% confidence interval for qualitative variables.
A comparison of both groups will be carried out at the beginning of the study, using t-Student or chi-square according to the nature of the variables and if the application conditions allow it.
Bivariate statistics will also be performed at the end of the study, to evaluate differences between both groups, and other independent variables, with respect to the outcome variables.
Multivariate statistics will be performed, by means of logistic regression, using as the dependent variable having or not achieved the decrease in hemoglobin and as independent variables those that have shown significance at the bivariate level.
Measured: 7 months
Secondary outcomes (1)
patient motivation
To evaluate the motivation and attitude of the patient with respect to his diabetes, in the initial visit and at the end of the intervention, the DAS-3sp questionnaire will be used. The proposed motivations and attitudes test is validated by J.Mª Hernandez et al. 19 (annex two). Where the changes in the global score of the scale between the visit at the beginning and at the end of the intervention will be assessed, comparing the initial and final tests.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start10 May 2021
- Primary completion31 Aug 2022
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fortnightly reinforcement of diabetes education, diet review, exercise, emotional support, doubts with insulin or oral medication and the registration of blood glucose controls, through telephone calls scheduled at a specific time during a semester.
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mª Dolores Rodríguez Garrido
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mª Dolores Rodríguez Garrido, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- MªDolores Rodriguez, diploma, Principal investigator, ICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932356
- Sponsor's protocol ID
- 4R16/146
- Acronym
- TTEDMV1
- Status last verified
- Aug 2022
- First submitted
- 12 Jun 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
J.M. Hernández, J. Basora, X. Ansa, J.L. Piñol, M. Millan, D. Figuerola. La versión española de la Diabetes Attitude Scale (DAS-3sp): un instrumento de medición de actitudes y motivaciones en Diabetes. Endocrinol Nutr., 49 (2002), pp. 293-298
Roca-Espino D, Orois-Añón A. El control de la diabetes a distancia. ¿Cuánto hay de verdaderamente útil bajo el término telemedicina? Avances en Diabetología 2015; 31(1):1-7.
Picón César MJ. Documento de posicionamiento sobre el uso de la telemedicina aplicada a la atencion diabetologica. Avances en diabetología 2010;26(3):147-150.
Zhou P, Xu L, Liu X, Huang J, Xu W, Chen W. Web-based telemedicine for management of type 2 diabetes through glucose uploads: a randomized controlled trial. Int J Clin Exp Pathol. 2014 Dec 1;7(12):8848-54. eCollection 2014.
PubMed 25674254Edmonds M, Bauer M, Osborn S, Lutfiyya H, Mahon J, Doig G, Grundy P, Gittens C, Molenkamp G, Fenlon D. Using the Vista 350 telephone to communicate the results of home monitoring of diabetes mellitus to a central database and to provide feedback. Int J Med Inform. 1998 Aug-Sep;51(2-3):117-25. doi: 10.1016/s1386-5056(98)00109-9.
PubMed 9794328Dennis SM, Harris M, Lloyd J, Powell Davies G, Faruqi N, Zwar N. Do people with existing chronic conditions benefit from telephone coaching? A rapid review. Aust Health Rev. 2013 Jun;37(3):381-8. doi: 10.1071/AH13005.
PubMed 23701944Kaur R, Kajal KS, Kaur A, Singh P. Telephonic Consultation and follow-up in Diabetics: Impact on Metabolic Profile, Quality of Life, and Patient Compliance. N Am J Med Sci. 2015 May;7(5):199-207. doi: 10.4103/1947-2714.157483.
PubMed 26110131Munshi MN, Segal AR, Suhl E, Ryan C, Sternthal A, Giusti J, Lee Y, Fitzgerald S, Staum E, Bonsignor P, DesRochers L, McCartney R, Weinger K. Assessment of barriers to improve diabetes management in older adults: a randomized controlled study. Diabetes Care. 2013 Mar;36(3):543-9. doi: 10.2337/dc12-1303. Epub 2012 Nov 27.
PubMed 23193208Izquierdo RE, Knudson PE, Meyer S, Kearns J, Ploutz-Snyder R, Weinstock RS. A comparison of diabetes education administered through telemedicine versus in person. Diabetes Care. 2003 Apr;26(4):1002-7. doi: 10.2337/diacare.26.4.1002.
PubMed 12663564Holtz B, Lauckner C. Diabetes management via mobile phones: a systematic review. Telemed J E Health. 2012 Apr;18(3):175-84. doi: 10.1089/tmj.2011.0119. Epub 2012 Feb 22.
PubMed 22356525Esmatjes E, Jansa M, Roca D, Perez-Ferre N, del Valle L, Martinez-Hervas S, Ruiz de Adana M, Linares F, Batanero R, Vazquez F, Gomis R, de Sola-Morales O; Telemed-Diabetes Group. The efficiency of telemedicine to optimize metabolic control in patients with type 1 diabetes mellitus: Telemed study. Diabetes Technol Ther. 2014 Jul;16(7):435-41. doi: 10.1089/dia.2013.0313. Epub 2014 Feb 14.
PubMed 24528195Klonoff DC. Using telemedicine to improve outcomes in diabetes--an emerging technology. J Diabetes Sci Technol. 2009 Jul 1;3(4):624-8. doi: 10.1177/193229680900300401. No abstract available.
PubMed 20144303Zolfaghari M, Mousavifar SA, Haghani H. Mobile phone text messaging and Telephone follow-up in type 2 diabetic patients for 3 months: a comparative study. J Diabetes Metab Disord. 2012 Aug 24;11(1):7. doi: 10.1186/2251-6581-11-7.
PubMed 23497735Zhai YK, Zhu WJ, Cai YL, Sun DX, Zhao J. Clinical- and cost-effectiveness of telemedicine in type 2 diabetes mellitus: a systematic review and meta-analysis. Medicine (Baltimore). 2014 Dec;93(28):e312. doi: 10.1097/MD.0000000000000312.
PubMed 25526482McGloin H, Timmins F, Coates V, Boore J. A case study approach to the examination of a telephone-based health coaching intervention in facilitating behaviour change for adults with Type 2 diabetes. J Clin Nurs. 2015 May;24(9-10):1246-57. doi: 10.1111/jocn.12692. Epub 2014 Oct 16.
PubMed 25319572
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Impact of a Telephone Therapeutic Education Program in DM2 Patients With Poor Metabolic Control Over Glycosylated Hemoglobin and Spontaneous Nursing Visits, in a Primary Care Center
- ClinicalTrials.gov ID
- NCT04932356
- Acronym / sponsor ID
- TTEDMV1 / 4R16/146
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Educational Technology, Diabetes Mellitus Type 2, Glycated Hemoglobin A, Pragmatic Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Mª Dolores Rodríguez GarridoUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes Mellitus (DM) is one of the most prevalent chronic diseases worldwide and with a significant impact on health spending.
The literature identifies that the telephone improves the process of clinical care and patient outcomes. Programs are known to have demonstrated improvements in HbA1c outcome in DM2.
In the majority of patients their follow-up is carried out from primary care, where they occupy a third of the visits, it is a main reason for consultation.
The mobile phone is becoming an interesting tool for therapeutic education.
The objective: To decrease the HbA1c value by 10% in patients who have their HbA1c >9% and 0.5% in those who have an HbA1c value <9%-Reduce the number of spontaneous visits in nursing consultations.
Know the attitude and motivations of the patients participating in the study It will be a probabilistic randomized intervention study at the Mas Font Primary Care Center in Viladecans (Barcelona).
According to medical history as of December 31, 2020, there were 1554 patients diagnosed with DM2, 402 DM2 patients with poor control (HbA1c >8%) Patients who meet inclusion criteria will be contacted by telephone or at consultations and will be offered to participate and sign consent.
They are then automatically randomized to intervention or control group. Study participants will be visited in person every six months and both groups will follow the center's protocol in face-to-face visits, The intervention group will be reinforced with a fortnightly telephone visit.
Detailed description
The study is of the probabilistic random intervention type, in a Primary Care center. The area where the study will be carried out: Population attached to ABS Mas Font over 18 years (18,431 people), in Viladecans (Barcelona). In the computerized medical history database, as of December 31, 2020, 1554 patients diagnosed with DM2 were found. By 2020 they had two HBa1cs registered in 402 patients (26% of all PATIENTS with DM2), only 711 (45.75%) 441 (28.4%) no. With one of the last two > 8 there are 145 patients. With the last two values > 8 there are 87 patients. Socio-economic data Typology according to CatSalut - Urban population with medium-high privacy MEDEA* ABS Viladecans Index 1 x 0'70 (Median of Catalonia 0'44) *It is a deprivation rate based on the following socio-economic indicators: manual workers, unemployment, eventual employees, total under-education and in 18 young people. Inclusion and exclusion criteria the denial of participating in the study. Sample calculation In the computerized medical history database, as of December 31, 2020, 1554 patients diagnosed with DM2 were consisting of 402 DM2 patients (26%) have at least two records of HbA1c. Accepting an alpha risk of 5%, beta less than 20%, in a unilateral contrast and waiting to detect a minimum difference of 0.9, for a deviation of 1.2 in HBa1c values and with losses not greater than 10%, 32 patients are required in each group. The sample should be increased by 20% in case there were drop outs, requiring a sample of 38 patients in each group to be able to find a difference in HbA1c. (IMIM GRANMO https://www.imim.es/ofertadeserveis/software-public/granmo/) Source of subjects From the list of patients who meet criteria you will get a sample Random. The collected patients will be contacted by telephone or at the consultations and offered to participate in the study. The purpose of the same will be explained and the confidentiality of the data will be ensured. If they agree to participate they will be summoned to the center where they sign the informed consent (see attached document). They are then automatically randomized to intervention or control group. Definition of variables Demographic:
-age: in Limitations and possible biases One limitation that we can find is that the data on the follow-up of the medication varies, since during a year the patient can change treatment, due to hospital admission (variable that will be collected in both groups and a stratified analysis will be performed if necessary).
The loss of follow-up of patients due to different causes (such as patients who can change cities during vacation periods and difficult telephone locations due to difficulties in coverage, changes of residence). The final impact of the study and the reason for the losses will be evaluated.
Lack of feedback between the patient and the nurse
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fortnightly reinforcement of diabetes education, diet review, exercise, emotional support, doubts with insulin or oral medication and the registration of blood glucose controls, through telephone calls scheduled at a specific time during a semester.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education by phone | Other | Other: Therapeutic education by phoneTherapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit and then reinforcement each 15 days over the weak points of this visit. |
| Traditional Therapeutic Education | Other | Other: Therapeutical education traditionalTherapeutic education in diabetes mellitus (pharmacological, nutritional, physical exercise, social adherence ... etc) on face-to-face visit. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DM2 patient with HbA1c > of 8%
- With some form of drug medication for their diabetes.
Key exclusion criteria (6 listed)
- persons with gestational diabetes,
- psychiatric disease
- hearing or vocalization problems,
- terminal patient in PADES,
- patient with chronic acute disease (MACA),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic education by phoneThe patients who participate in the intervention group, after their face-to-face visit, will undergo a fortnightly reinforcement by telephone of diabetes education (review of diet, physical exercise, doubts about insulin or oral medication and the registry of blood glucose controls). In addition, emotional support will be provided to the patient, along with a semester calendar with scheduled calls to carry out the intervention, at a specific time. | Other | Therapeutic Education by phone |
| Therapeutical education traditionalThe patients participating in the study will be visited in person every six months where the control group will follow the usual protocol of the health center in the face-to-face visits, with their respective analyzes and pertinent tests, together with health education and adherence to pharmacological treatment. | Other | Traditional Therapeutic Education |
Primary outcome
HbA1c Result
Time frame: 7 months
Descriptive statistics of the variables will be carried out, using measures of central tendency and dispersion for quantitative variables and percentages with a 95% confidence interval for qualitative variables. A comparison of both groups will be carried out at the beginning of the study, using t-Student or chi-square according to the nature of the variables and if the application conditions allow it. Bivariate statistics will also be performed at the end of the study, to evaluate differences between both groups, and other independent variables, with respect to the outcome variables. Multivariate statistics will be performed, by means of logistic regression, using as the dependent variable having or not achieved the decrease in hemoglobin and as independent variables those that have shown significance at the bivariate level.
1 secondary outcome
patient motivation
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- BackgroundJ.M. Hernández, J. Basora, X. Ansa, J.L. Piñol, M. Millan, D. Figuerola. La versión española de la Diabetes Attitude Scale (DAS-3sp): un instrumento de medición de actitudes y motivaciones en Diabetes. Endocrinol Nutr., 49 (2002), pp. 293-298
- BackgroundRoca-Espino D, Orois-Añón A. El control de la diabetes a distancia. ¿Cuánto hay de verdaderamente útil bajo el término telemedicina? Avances en Diabetología 2015; 31(1):1-7.
- BackgroundPicón César MJ. Documento de posicionamiento sobre el uso de la telemedicina aplicada a la atencion diabetologica. Avances en diabetología 2010;26(3):147-150.
- Background: PubMed 25674254Zhou P, Xu L, Liu X, Huang J, Xu W, Chen W. Web-based telemedicine for management of type 2 diabetes through glucose uploads: a randomized controlled trial. Int J Clin Exp Pathol. 2014 Dec 1;7(12):8848-54. eCollection 2014.
- Results publication: PubMed 9794328Edmonds M, Bauer M, Osborn S, Lutfiyya H, Mahon J, Doig G, Grundy P, Gittens C, Molenkamp G, Fenlon D. Using the Vista 350 telephone to communicate the results of home monitoring of diabetes mellitus to a central database and to provide feedback. Int J Med Inform. 1998 Aug-Sep;51(2-3):117-25. doi: 10.1016/s1386-5056(98)00109-9.
- Results publication: PubMed 23701944Dennis SM, Harris M, Lloyd J, Powell Davies G, Faruqi N, Zwar N. Do people with existing chronic conditions benefit from telephone coaching? A rapid review. Aust Health Rev. 2013 Jun;37(3):381-8. doi: 10.1071/AH13005.
- Results publication: PubMed 26110131Kaur R, Kajal KS, Kaur A, Singh P. Telephonic Consultation and follow-up in Diabetics: Impact on Metabolic Profile, Quality of Life, and Patient Compliance. N Am J Med Sci. 2015 May;7(5):199-207. doi: 10.4103/1947-2714.157483.
- Results publication: PubMed 23193208Munshi MN, Segal AR, Suhl E, Ryan C, Sternthal A, Giusti J, Lee Y, Fitzgerald S, Staum E, Bonsignor P, DesRochers L, McCartney R, Weinger K. Assessment of barriers to improve diabetes management in older adults: a randomized controlled study. Diabetes Care. 2013 Mar;36(3):543-9. doi: 10.2337/dc12-1303. Epub 2012 Nov 27.
- Results publication: PubMed 12663564Izquierdo RE, Knudson PE, Meyer S, Kearns J, Ploutz-Snyder R, Weinstock RS. A comparison of diabetes education administered through telemedicine versus in person. Diabetes Care. 2003 Apr;26(4):1002-7. doi: 10.2337/diacare.26.4.1002.
- Results publication: PubMed 22356525Holtz B, Lauckner C. Diabetes management via mobile phones: a systematic review. Telemed J E Health. 2012 Apr;18(3):175-84. doi: 10.1089/tmj.2011.0119. Epub 2012 Feb 22.
- Results publication: PubMed 24528195Esmatjes E, Jansa M, Roca D, Perez-Ferre N, del Valle L, Martinez-Hervas S, Ruiz de Adana M, Linares F, Batanero R, Vazquez F, Gomis R, de Sola-Morales O; Telemed-Diabetes Group. The efficiency of telemedicine to optimize metabolic control in patients with type 1 diabetes mellitus: Telemed study. Diabetes Technol Ther. 2014 Jul;16(7):435-41. doi: 10.1089/dia.2013.0313. Epub 2014 Feb 14.
- Results publication: PubMed 20144303Klonoff DC. Using telemedicine to improve outcomes in diabetes--an emerging technology. J Diabetes Sci Technol. 2009 Jul 1;3(4):624-8. doi: 10.1177/193229680900300401. No abstract available.
- Human Experimentation. Code of Ethics of the World Medical Association. Declaration of Helsinki.Link provided by the sponsor.
- Construcción de un índice de privación a partir de datos censales en grandes ciudades españolas: (Proyecto MEDEA).Link provided by the sponsor.
- 10\. Orozco-Beltrán D, et al. Abordaje de la adherencia en diabetes mellitus tipo 2: situación actual y propuesta de posibles soluciones.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MªDolores Rodriguez, diploma principal investigator
ICS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education by phone and Therapeutical education traditional in people with Diabetes Mellitus, Type 2, run by Mª Dolores Rodríguez Garrido at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MªDolores Rodriguez, diploma (630942731 ext. +34, lolirodriguezgarrido@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c Result (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932356, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.