Diabetes Mellitus, Type 1NCT02790645
Telemedicine Program in Type 1 Diabetes and CSII
A study testing Group 2a. Telemedicine program and Group 1b.Telemedicine program in people with Diabetes Mellitus, Type 1, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Trial summary
Diabetes mellitus is a chronic disease of high socio-health relevance for their clinical and economic implications (risk of complications, disability ...) (healthcare costs). Strict glycemic control and intensive treatment and support have shown long-term patient with type 1 diabetes mellitus (DM1) improved health. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Group 2a. Telemedicine program and Group 1b.Telemedicine program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to 19 Sep 2016
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetes over 2 years of development with C plasma levels <0.5 ng / ml, and ISCI treated for> 6 months peptide.
- Age between 16 and 65 years (inclusive).
- HbA1c <10%.
- Absence of concomitant drug therapy that could affect blood glucose levels.
- Absence of chronic renal failure, abnormal liver function tests, thyroid disease active (except properly replaced hypothyroidism).
- Absence of acute decompensation Ketotic at baseline.
Who cannot join
- type 2 diabetes.
- type 1 diabetes treated with multiple daily insulin injections.
- Women pregnant or planning pregnancy.
- severe macrovascular or microvascular complications
- disabling psychological disorders.
- No collaboration (not signed informed consent).
About this study
Official title: Randomized Crossover Clinical Trial in Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion to Assess the Impact of Telemedicine vs. Conventional Medical Care. Integral Clinical Impact and Cost
Diabetes mellitus is a chronic disease of high socio-health relevance for their clinical and economic implications (risk of complications, disability ...) (healthcare costs). Strict glycemic control and intensive treatment and support have shown long-term patient with type 1 diabetes mellitus (DM1) improved health. The intensive insulin therapy involves the administration of insulin through 3 or more injections per day (MDI), or through a continuous subcutaneous insulin infusion (CSII). New technologies applied to the treatment of DM1, such as telemedicine, could bring benefits to patients. The available scientific evidence to date shows that telemedicine systems have beneficial or neutral effects on glycemic control, expressed in terms of HbA1c in patients with type 1 diabetes treated with MDI or CSII. They have also shown not to worsen the quality of life and reduce the costs associated with the care of these subjects. However, studies published to date are generally short follow-up, small sample size, and have not evaluated other biological parameters such as glycemic variability, inflammatory markers and markers of oxidative stress as well as a psychological assessment including depression, anxiety, Diabetes-related distress and fear of hypoglycemia. It has been designed a randomized crossover 18 months in order to study the effect of a telemedicine program in a group of subjects with DM1 in CSII on clinical variables of metabolic control variables, including parameters of glycemic variability, markers of inflammation and oxidative stress, psychological variables and quality of life, and associated costs.
Read the detailed description
Randomized crossover clinical trial about the impact of a telemedicine program (Emminens Conecta® System, Roche Diagnostics SL) vs. the conventional medical follow-face of 18 months for the care of patients with DM1 intensive treatment with CSII (Accu-Chek Spirit®, Roche SL).
Two groups: one group with interactive clinical monitoring through a telemedicine platform (TM) and other conventional medical follow-up group (SMC) during 6 months. Being a crossover trial, both groups passing through both conditions (TM and SMC) during 6 months.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Group 2a. Telemedicine program, Group 1a. Control, Group 1b.Telemedicine program, Group 2b. Control
- Keywords
- Type 1 diabetes, Health technologies, Continuous subcutaneous insulin infusion, Telemedicine, Glycemic variability, Inflammatory markers,, Oxidative stress, Depression, Quality of life, Cost-effectiveness
- Medical subject headings
- Diabetes Mellitus, Type 1, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 2a. Telemedicine programOther
CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
Group 1a. ControlOther
Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months).
Group 1b.Telemedicine programOther
After a washout period of 3 months and the crossing, Group 1 begins with medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
Group 2b. ControlOther
After a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months) .
| Study group | Role | What they receive |
|---|---|---|
| Group 1a. Control | Other | Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months). Receives: Other: Group 1a. Control |
| Group 2a. Telemedicine program | Other | CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months). Receives: Other: Group 2a. Telemedicine program |
| Group 1b. Telemedicine program | Other | After a washout period of 3 months and the crossing, Group 1 begins with medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months). Receives: Other: Group 1b.Telemedicine program |
| Group 2b. Control | Other | After a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months). Receives: Other: Group 2b. Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
Measured: Baseline: Group 1 and 2
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Secondary outcomes (28)
Assessment of inflammatory markers (hs-CRP).
Measured: Baseline: Group 1 and 2
Assessment of inflammatory markers (IL-6).
Measured: Baseline: Group 1 and 2
Assessment of inflammatory markers (TNF-α).
Measured: Baseline: Group 1 and 2
Assessment of inflammatory markers (MCP-1).
Measured: Baseline: Group 1 and 2
Assessment of inflammatory markers (hs-CRP).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (IL-6).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (TNF-α).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (MCP-1).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (CAT).
Measured: Baseline: Group 1 and 2
Assessment of redox markers (TBARS).
Measured: Baseline: Group 1 and 2
Assessment of redox markers (oxidized LDL).
Measured: Baseline: Group 1 and 2
Assessment of redox markers (CAT).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (TBARS).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (oxidized LDL).
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of quality of life with the DQOL
Measured: Baseline: Group 1 and 2
Assessment of quality of life with the DQOL
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of depression with the BDI-II
Measured: Baseline: Group 1 and 2
Assessment of depression with the BDI-II
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of anxiety with the STAI
Measured: Baseline: Group 1 and 2
Assessment of anxiety with the STAI
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of distress related to diabetes with the DDS
Measured: Baseline: Group 1 and 2
Assessment of distress related to diabetes with the DDS
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of treatment satisfaction with the DTSQ
Measured: Baseline: Group 1 and 2
Assessment of treatment satisfaction with the DTSQ
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of fear of hypoglycemia with the FH-15
Measured: Baseline: Group 1 and 2
Assessment of fear of hypoglycemia with the FH-15
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of cost-effectiveness with a structured interview designed by our research group of direct and indirect costs.
Measured: Baseline: Group 1 and 2; 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of cost-effectiveness with a structured interview designed by our research group of direct and indirect costs.
Measured: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startSep 2012
- Primary completionApr 2016
- Study completion19 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Andaluz Health Service, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Soledad Ruiz de Adana, MD, PhD, Principal investigator, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790645
- Sponsor's protocol ID
- CSII TELEMEDICINE PROGRAM
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2016
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jansa M, Vidal M, Viaplana J, Levy I, Conget I, Gomis R, Esmatjes E. Telecare in a structured therapeutic education programme addressed to patients with type 1 diabetes and poor metabolic control. Diabetes Res Clin Pract. 2006 Oct;74(1):26-32. doi: 10.1016/j.diabres.2006.03.005. Epub 2006 Apr 18.
PubMed 16621113Blanchet KD. Telehealth and diabetes monitoring. Telemed J E Health. 2008 Oct;14(8):744-6. doi: 10.1089/tmj.2008.8483. No abstract available.
PubMed 18954243
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Crossover Clinical Trial in Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion to Assess the Impact of Telemedicine vs. Conventional Medical Care. Integral Clinical Impact and Cost
- ClinicalTrials.gov ID
- NCT02790645
- Acronym / sponsor ID
- CSII TELEMEDICINE PROGRAM
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes, Health technologies, Continuous subcutaneous insulin infusion, Telemedicine, Glycemic variability, Inflammatory markers,, Oxidative stress, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Andaluz Health Service, Roche Pharma AG
- Study start
- Sep 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- 19 Sep 2016 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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 is a chronic disease of high socio-health relevance for their clinical and economic implications (risk of complications, disability ...) (healthcare costs). Strict glycemic control and intensive treatment and support have shown long-term patient with type 1 diabetes mellitus (DM1) improved health. The intensive insulin therapy involves the administration of insulin through 3 or more injections per day (MDI), or through a continuous subcutaneous insulin infusion (CSII). New technologies applied to the treatment of DM1, such as telemedicine, could bring benefits to patients. The available scientific evidence to date shows that telemedicine systems have beneficial or neutral effects on glycemic control, expressed in terms of HbA1c in patients with type 1 diabetes treated with MDI or CSII. They have also shown not to worsen the quality of life and reduce the costs associated with the care of these subjects. However, studies published to date are generally short follow-up, small sample size, and have not evaluated other biological parameters such as glycemic variability, inflammatory markers and markers of oxidative stress as well as a psychological assessment including depression, anxiety, Diabetes-related distress and fear of hypoglycemia. It has been designed a randomized crossover 18 months in order to study the effect of a telemedicine program in a group of subjects with DM1 in CSII on clinical variables of metabolic control variables, including parameters of glycemic variability, markers of inflammation and oxidative stress, psychological variables and quality of life, and associated costs.
Detailed description
Randomized crossover clinical trial about the impact of a telemedicine program (Emminens Conecta® System, Roche Diagnostics SL) vs. the conventional medical follow-face of 18 months for the care of patients with DM1 intensive treatment with CSII (Accu-Chek Spirit®, Roche SL).
Two groups: one group with interactive clinical monitoring through a telemedicine platform (TM) and other conventional medical follow-up group (SMC) during 6 months. Being a crossover trial, both groups passing through both conditions (TM and SMC) during 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1a. Control | Other | Other: Group 1a. ControlTreatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months). |
| Group 2a. Telemedicine program | Other | Other: Group 2a. Telemedicine programCSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months). |
| Group 1b. Telemedicine program | Other | Other: Group 1b.Telemedicine programAfter a washout period of 3 months and the crossing, Group 1 begins with medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months). |
| Group 2b. Control | Other | Other: Group 2b. ControlAfter a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months). |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 diabetes over 2 years of development with C plasma levels <0.5 ng / ml, and ISCI treated for> 6 months peptide.
- Age between 16 and 65 years (inclusive).
- HbA1c <10%.
- Absence of concomitant drug therapy that could affect blood glucose levels.
- Absence of chronic renal failure, abnormal liver function tests, thyroid disease active (except properly replaced hypothyroidism).
Key exclusion criteria (6 listed)
- type 2 diabetes.
- type 1 diabetes treated with multiple daily insulin injections.
- Women pregnant or planning pregnancy.
- severe macrovascular or microvascular complications
- disabling psychological disorders.
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 |
|---|---|---|
| Group 2a. Telemedicine programCSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months). | Other | Group 2a. Telemedicine program |
| Group 1a. ControlTreatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months). | Other | Group 1a. Control |
| Group 1b.Telemedicine programAfter a washout period of 3 months and the crossing, Group 1 begins with medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months). | Other | Group 1b. Telemedicine program |
| Group 2b. ControlAfter a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months) . | Other | Group 2b. Control |
Primary outcome
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
Time frame: Baseline: Group 1 and 2
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
28 secondary outcomes
Assessment of inflammatory markers (hs-CRP).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (IL-6).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (TNF-α).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (MCP-1).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (hs-CRP).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (IL-6).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (TNF-α).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (MCP-1).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (CAT).
Time frame: Baseline: Group 1 and 2
Assessment of redox markers (TBARS).
Time frame: Baseline: Group 1 and 2
Assessment of redox markers (oxidized LDL).
Time frame: Baseline: Group 1 and 2
Assessment of redox markers (CAT).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (TBARS).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (oxidized LDL).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of quality of life with the DQOL
Time frame: Baseline: Group 1 and 2
Assessment of quality of life with the DQOL
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of depression with the BDI-II
Time frame: Baseline: Group 1 and 2
Assessment of depression with the BDI-II
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of anxiety with the STAI
Time frame: Baseline: Group 1 and 2
Assessment of anxiety with the STAI
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of distress related to diabetes with the DDS
Time frame: Baseline: Group 1 and 2
Assessment of distress related to diabetes with the DDS
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of treatment satisfaction with the DTSQ
Time frame: Baseline: Group 1 and 2
Assessment of treatment satisfaction with the DTSQ
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of fear of hypoglycemia with the FH-15
Time frame: Baseline: Group 1 and 2
Assessment of fear of hypoglycemia with the FH-15
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of cost-effectiveness with a structured interview designed by our research group of direct and indirect costs.
Time frame: Baseline: Group 1 and 2; 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of cost-effectiveness with a structured interview designed by our research group of direct and indirect costs.
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Background: PubMed 16621113Jansa M, Vidal M, Viaplana J, Levy I, Conget I, Gomis R, Esmatjes E. Telecare in a structured therapeutic education programme addressed to patients with type 1 diabetes and poor metabolic control. Diabetes Res Clin Pract. 2006 Oct;74(1):26-32. doi: 10.1016/j.diabres.2006.03.005. Epub 2006 Apr 18.
- Background: PubMed 18954243Blanchet KD. Telehealth and diabetes monitoring. Telemed J E Health. 2008 Oct;14(8):744-6. doi: 10.1089/tmj.2008.8483. No abstract available.
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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.
Soledad Ruiz de Adana, MD, PhD principal investigator
Andaluz Health Service
Questions about this trial
What is this clinical trial studying?
A study testing Group 2a. Telemedicine program and Group 1b.Telemedicine program in people with Diabetes Mellitus, Type 1, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
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 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: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-). (time frame: Baseline: Group 1 and 2). 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 NCT02790645, which also lists 2 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 Jul 2017.