Diabetes Mellitus, Type 1NCT03455816
Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")
A study testing Social Diabetes App in people with Diabetes Mellitus, Type 1, run by Soledad Ruiz de Adana at 1 site in Spain.
Trial summary
Based on international recommendations, the current clinical research project considers the effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC technology the automatic introduction of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Social Diabetes App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jul 2017to Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with DM1 over 1 year evolution.
- Age ≥18 and <65 years.
- HbA1c prior to the inclusion of the study> 7%.
- Intensive insulin treatment with MDI in basal-bolus regimen.
- Patients with basic digital skills and with 3G mobile phone and NFC technology.
- Patients who have given their informed consent in writing.
Who cannot join
- Treatment with subcutaneous insulin infusor (ISCI)
- Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
- Pregnancy or pregnancy planning.
- Diabetes mellitus type 2.
- Severe psychological alterations.
- Absence of collaboration (informed consent).
- Patients who are participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Regional University Hospital of Málaga
Málaga
Maria Soledad Ruiz de Adana, MD PhD, +34 629221089, solruizdeadana@gmail.com
Virginia Morillas Jiménez, MD PhD
About this study
Official title: Randomized Clinical Study to Evaluate the Bio-Psychosocial Impact of a Mobile App for Diabetes ("SOCIAL DIABETES") and a SMARTMETER® (A. MENARINI DIAGNOSTICS) in the Care of People With Diabetes Mellitus Type 1 and Its Associated Costs
Based on international recommendations, the current clinical research project considers the effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1 through a randomized randomized study during 6 months of follow-up.
Read the detailed description
Randomized study in people with type 1 diabetes in intensive insulin therapy MDI with analogues and with HbA1c> 7% to the usual clinical follow-up options (CG) vs use of Social Diabetes App (GI) for 6 months.
The current clinical research project considers the effectiveness of a free diabetes app with a CE mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC (Near Field Communication) technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1.
The substitution of the usual face-to-face medical visit every 3-4 months by the incorporation of an app system has a similar effect in terms of glycemic control (measured through HbA1c) in patients with DM1 treated with multiple doses of insulin per day (MDI). ) and inadequate metabolic control (HbA1c> 7%). In addition, it could save costs and consumption of health resources, and improve both the quality of life and the satisfaction of people with DM1.
The present study will be carried out under the usual conditions of clinical practice.
No pharmacological intervention, other than the usual clinical practice, will be applied to the included patients.
The people with diabetes 1 included in the study have a profile of "expert patient" having completed their diabetological education program at basic and advanced level (count of rations, calculations of ratios and sensitivity indexes) in such a way that the application will only be an aid in your daily decision making (mathematical calculations of ratios, IS, and recommended insulin doses, which you usually have to do "by hand").
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Social Diabetes App, Usual clinical monitoring group (Control group)
- Keywords
- mobile app
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Diabetes AppDevice
Social diabetes is an app for diabetes, free with CE mark, that by means of the incorporation of a glucometer ("glucomen Areo") allows through NFC technology the automatic introduction of data in the application
Usual clinical monitoring group (Control group)Device
Active Comparator: Usual clinical monitoring group (control group) This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments
| Study group | Role | What they receive |
|---|---|---|
| Group that uses the Social Diabetes App (research group) | Experimental | This group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month Receives: Device: Social Diabetes App |
| Usual clinical monitoring group (control group) | Active comparator | This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments Receives: Device: Usual clinical monitoring group (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated hemoglobin
Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.
Measured: 6 month
Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire.
34 items to analyze the biopsychosocial impact measured through the quality of life questionnaire (DQol) of a mobile application (Social Diabetes) in the care of people with DM1.
Measured: 6 month
Secondary outcomes (12)
Mean blood glucose
Glycemic control: Mean blood glucose measured in mg / dl
Measured: 6 month
Standard deviation
Glycemic variability: Standard deviation ( SD)
Measured: 6 month
Number of mild hypoglycaemia
Number of mild hypoglycemia in two weeks
Measured: 6 month
Number of severe hypoglycaemia
Number of severe hypoglycaemia in the last 6 months
Measured: 6 month
Number of hyperglycemia
Number of hyperglycemia greater than 250mg / dl in two weeks
Measured: 6 month
Episodes of ketosis
Number of episodes of ketosis in the last 6 months
Measured: 6 month
Episodes of ketoacidosis
Number of episodes of ketoacidosis in the last 6 months
Measured: 6 month
Number of hospital admissions for glycemic decompensation
Number of hospital admissions for glycemic decompensation in the last 6 months.
Measured: 6 month
Fear of hypoglycemia: Questionnaire FH-15
Fear of hypoglycemia: measured with the FH-15 scale. 15 items related to the fear of hypoglycemia in patients with type 1 diabetes.
Measured: 6 month
Diabetes treatment satisfaction questionnaire ( DTSQ)
8 items concerning the satisfaction of the treatment
Measured: 6 month
Diabetes distress scale. DDS
17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col,2005)
Measured: 6 month
Scale of adherence to treatment in patients with diabetes type 1
15 items related to adherence to patient treatment
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 posted7 Mar 2018
- Study start7 Jul 2017
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soledad Ruiz de Adana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soledad Ruiz de Adana, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455816
- Sponsor's protocol ID
- Social Diabetes
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lewis TL, Boissaud-Cooke MA, Aungst TD, Eysenbach G. Consensus on use of the term "App" versus "Application" for reporting of mHealth research. J Med Internet Res. 2014 Jul 17;16(7):e174; discussion e174. doi: 10.2196/jmir.3460. No abstract available.
PubMed 25033233Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Franc S, Daoudi A, Mounier S, Boucherie B, Dardari D, Laroye H, Neraud B, Requeda E, Canipel L, Charpentier G. Telemedicine and diabetes: achievements and prospects. Diabetes Metab. 2011 Dec;37(6):463-76. doi: 10.1016/j.diabet.2011.06.006. Epub 2011 Sep 1.
PubMed 21889388Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ. 2002 May 18;324(7347):1193-4. doi: 10.1136/bmj.324.7347.1193. No abstract available.
PubMed 12016186Holtz 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 22356525Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res. 2011 Sep 22;13(3):e65. doi: 10.2196/jmir.1874.
PubMed 21979293Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.
PubMed 21266648Kirwan M, Vandelanotte C, Fenning A, Duncan MJ. Diabetes self-management smartphone application for adults with type 1 diabetes: randomized controlled trial. J Med Internet Res. 2013 Nov 13;15(11):e235. doi: 10.2196/jmir.2588.
PubMed 24225149Vahatalo M. Cellular phone transferred self blood glucose monitoring: Prerequisites for positive outcome. Practical Diabetes International 2004;21(5):192-194.
Gomez EJ, Hernando Perez ME, Vering T, Rigla Cros M, Bott O, Garcia-Saez G, Pretschner P, Brugues E, Schnell O, Patte C, Bergmann J, Dudde R, de Leiva A. The INCA system: a further step towards a telemedical artificial pancreas. IEEE Trans Inf Technol Biomed. 2008 Jul;12(4):470-9. doi: 10.1109/TITB.2007.902162.
PubMed 18632327Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.
PubMed 17395516Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058.
PubMed 22564332Froisland DH, Arsand E, Skarderud F. Improving diabetes care for young people with type 1 diabetes through visual learning on mobile phones: mixed-methods study. J Med Internet Res. 2012 Aug 6;14(4):e111. doi: 10.2196/jmir.2155.
PubMed 22868871Piette JD. Interactive behavior change technology to support diabetes self-management: where do we stand? Diabetes Care. 2007 Oct;30(10):2425-32. doi: 10.2337/dc07-1046. Epub 2007 Jun 22. No abstract available.
PubMed 17586735Montori VM, Helgemoe PK, Guyatt GH, Dean DS, Leung TW, Smith SA, Kudva YC. Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Diabetes Care. 2004 May;27(5):1088-94. doi: 10.2337/diacare.27.5.1088.
PubMed 15111526
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study to Evaluate the Bio-Psychosocial Impact of a Mobile App for Diabetes ("SOCIAL DIABETES") and a SMARTMETER® (A. MENARINI DIAGNOSTICS) in the Care of People With Diabetes Mellitus Type 1 and Its Associated Costs
- ClinicalTrials.gov ID
- NCT03455816
- Acronym / sponsor ID
- Social Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- mobile app
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Soledad Ruiz de AdanaUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Mar 2018 (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.
Based on international recommendations, the current clinical research project considers the effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1 through a randomized randomized study during 6 months of follow-up.
Detailed description
Randomized study in people with type 1 diabetes in intensive insulin therapy MDI with analogues and with HbA1c> 7% to the usual clinical follow-up options (CG) vs use of Social Diabetes App (GI) for 6 months.
The current clinical research project considers the effectiveness of a free diabetes app with a CE mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC (Near Field Communication) technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1.
The substitution of the usual face-to-face medical visit every 3-4 months by the incorporation of an app system has a similar effect in terms of glycemic control (measured through HbA1c) in patients with DM1 treated with multiple doses of insulin per day (MDI). ) and inadequate metabolic control (HbA1c> 7%). In addition, it could save costs and consumption of health resources, and improve both the quality of life and the satisfaction of people with DM1.
The present study will be carried out under the usual conditions of clinical practice.
No pharmacological intervention, other than the usual clinical practice, will be applied to the included patients.
The people with diabetes 1 included in the study have a profile of "expert patient" having completed their diabetological education program at basic and advanced level (count of rations, calculations of ratios and sensitivity indexes) in such a way that the application will only be an aid in your daily decision making (mathematical calculations of ratios, IS, and recommended insulin doses, which you usually have to do "by hand").
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group that uses the Social Diabetes App (research group) | Experimental | Device: Social Diabetes AppThis group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month |
| Usual clinical monitoring group (control group) | Active comparator | Device: Usual clinical monitoring group (Control group)This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with DM1 over 1 year evolution.
- Age ≥18 and <65 years.
- HbA1c prior to the inclusion of the study> 7%.
- Intensive insulin treatment with MDI in basal-bolus regimen.
- Patients with basic digital skills and with 3G mobile phone and NFC technology.
Key exclusion criteria (7 listed)
- Treatment with subcutaneous insulin infusor (ISCI)
- Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
- Pregnancy or pregnancy planning.
- Diabetes mellitus type 2.
- Severe psychological alterations.
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 |
|---|---|---|
| Social Diabetes AppSocial diabetes is an app for diabetes, free with CE mark, that by means of the incorporation of a glucometer ("glucomen Areo") allows through NFC technology the automatic introduction of data in the application | Device | Group that uses the Social Diabetes App (research group) |
| Usual clinical monitoring group (Control group)Active Comparator: Usual clinical monitoring group (control group) This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments | Device | Usual clinical monitoring group (control group) |
Primary outcome
glycosylated hemoglobin
Time frame: 6 month
Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.
Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire.
Time frame: 6 month
34 items to analyze the biopsychosocial impact measured through the quality of life questionnaire (DQol) of a mobile application (Social Diabetes) in the care of people with DM1.
12 secondary outcomes
Mean blood glucose
Time frame: 6 month
Standard deviation
Time frame: 6 month
Number of mild hypoglycaemia
Time frame: 6 month
Number of severe hypoglycaemia
Time frame: 6 month
Number of hyperglycemia
Time frame: 6 month
Episodes of ketosis
Time frame: 6 month
Episodes of ketoacidosis
Time frame: 6 month
Number of hospital admissions for glycemic decompensation
Time frame: 6 month
Fear of hypoglycemia: Questionnaire FH-15
Time frame: 6 month
Diabetes treatment satisfaction questionnaire ( DTSQ)
Time frame: 6 month
Diabetes distress scale. DDS
Time frame: 6 month
Scale of adherence to treatment in patients with diabetes type 1
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 13 Mar 2018.
- Background: PubMed 25033233Lewis TL, Boissaud-Cooke MA, Aungst TD, Eysenbach G. Consensus on use of the term "App" versus "Application" for reporting of mHealth research. J Med Internet Res. 2014 Jul 17;16(7):e174; discussion e174. doi: 10.2196/jmir.3460. No abstract available.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 21889388Franc S, Daoudi A, Mounier S, Boucherie B, Dardari D, Laroye H, Neraud B, Requeda E, Canipel L, Charpentier G. Telemedicine and diabetes: achievements and prospects. Diabetes Metab. 2011 Dec;37(6):463-76. doi: 10.1016/j.diabet.2011.06.006. Epub 2011 Sep 1.
- Background: PubMed 12016186Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ. 2002 May 18;324(7347):1193-4. doi: 10.1136/bmj.324.7347.1193. No abstract available.
- Background: 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.
- Background: PubMed 21979293Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res. 2011 Sep 22;13(3):e65. doi: 10.2196/jmir.1874.
- Background: PubMed 21266648Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.
- Background: PubMed 24225149Kirwan M, Vandelanotte C, Fenning A, Duncan MJ. Diabetes self-management smartphone application for adults with type 1 diabetes: randomized controlled trial. J Med Internet Res. 2013 Nov 13;15(11):e235. doi: 10.2196/jmir.2588.
- BackgroundVahatalo M. Cellular phone transferred self blood glucose monitoring: Prerequisites for positive outcome. Practical Diabetes International 2004;21(5):192-194.
- Background: PubMed 18632327Gomez EJ, Hernando Perez ME, Vering T, Rigla Cros M, Bott O, Garcia-Saez G, Pretschner P, Brugues E, Schnell O, Patte C, Bergmann J, Dudde R, de Leiva A. The INCA system: a further step towards a telemedical artificial pancreas. IEEE Trans Inf Technol Biomed. 2008 Jul;12(4):470-9. doi: 10.1109/TITB.2007.902162.
- Background: PubMed 17395516Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.
- Background: PubMed 22564332Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058.
- Smith A. Pew Internet \& American Life Project. Washington, DC 20036: Pew Research Center; 2012 Mar 01. Nearly half of American adults are Smart phone ownersLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Diabetes App in people with Diabetes Mellitus, Type 1, run by Soledad Ruiz de Adana 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 6 inclusion and 7 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 13 Mar 2018. 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 Maria Soledad Ruiz de Adana, MD PhD (+34 629221089, solruizdeadana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycosylated hemoglobin (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT03455816, which also lists 25 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 13 Mar 2018.