Telemedicine Program in Type 1 Diabetes and CSII

July 12, 2017 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group 1a. Control
Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months).
Other: Group 1a. Control
Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months).
Other: Group 2a. Telemedicine program
CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
Other: Group 2a. Telemedicine program
CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
Other: Group 1b. Telemedicine program
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).
Other: Group 1b.Telemedicine program
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).
Other: Group 2b. Control
After 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
After a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months) .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
Time Frame: Baseline: Group 1 and 2
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)
6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment of inflammatory markers (hs-CRP).
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of inflammatory markers (IL-6).
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of inflammatory markers (TNF-α).
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of inflammatory markers (MCP-1).
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of inflammatory markers (hs-CRP).
Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
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)
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)
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)
6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (CAT).
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of redox markers (TBARS).
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of redox markers (oxidized LDL).
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of redox markers (CAT).
Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
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)
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)
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
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)
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
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)
6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of anxiety with the STAI
Time Frame: Baseline: Group 1 and 2
Baseline: Group 1 and 2
Assessment of anxiety with the STAI
Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
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
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)
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
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)
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
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)
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)
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)
6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG
Andaluz Health Service
Ministerio de Economía y Competitividad, Spain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Soledad Ruiz de Adana, MD, PhD, Andaluz Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSII TELEMEDICINE PROGRAM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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