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Trial record 71 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

Telemedicine Program in Type 1 Diabetes and CSII

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ClinicalTrials.gov Identifier: NCT02790645
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : July 13, 2017
Sponsor:
Collaborators:
Ministerio de Economía y Competitividad, Spain
Andaluz Health Service
Roche Pharma AG
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Group 2a. Telemedicine program Other: Group 1a. Control Other: Group 1b.Telemedicine program Other: Group 2b. Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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).

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).

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).

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) .




Primary Outcome Measures :
  1. Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-). [ Time Frame: Baseline: Group 1 and 2 ]
  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) ]

Secondary Outcome Measures :
  1. Assessment of inflammatory markers (hs-CRP). [ Time Frame: Baseline: Group 1 and 2 ]
  2. Assessment of inflammatory markers (IL-6). [ Time Frame: Baseline: Group 1 and 2 ]
  3. Assessment of inflammatory markers (TNF-α). [ Time Frame: Baseline: Group 1 and 2 ]
  4. Assessment of inflammatory markers (MCP-1). [ Time Frame: Baseline: Group 1 and 2 ]
  5. Assessment of inflammatory markers (hs-CRP). [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  6. Assessment of inflammatory markers (IL-6). [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  7. Assessment of inflammatory markers (TNF-α). [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  8. Assessment of inflammatory markers (MCP-1). [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  9. Assessment of redox markers (CAT). [ Time Frame: Baseline: Group 1 and 2 ]
  10. Assessment of redox markers (TBARS). [ Time Frame: Baseline: Group 1 and 2 ]
  11. Assessment of redox markers (oxidized LDL). [ Time Frame: Baseline: Group 1 and 2 ]
  12. Assessment of redox markers (CAT). [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  13. Assessment of redox markers (TBARS). [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  14. Assessment of redox markers (oxidized LDL). [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  15. Assessment of quality of life with the DQOL [ Time Frame: Baseline: Group 1 and 2 ]
  16. Assessment of quality of life with the DQOL [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  17. Assessment of depression with the BDI-II [ Time Frame: Baseline: Group 1 and 2 ]
  18. Assessment of depression with the BDI-II [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  19. Assessment of anxiety with the STAI [ Time Frame: Baseline: Group 1 and 2 ]
  20. Assessment of anxiety with the STAI [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  21. Assessment of distress related to diabetes with the DDS [ Time Frame: Baseline: Group 1 and 2 ]
  22. Assessment of distress related to diabetes with the DDS [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  23. Assessment of treatment satisfaction with the DTSQ [ Time Frame: Baseline: Group 1 and 2 ]
  24. Assessment of treatment satisfaction with the DTSQ [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  25. Assessment of fear of hypoglycemia with the FH-15 [ Time Frame: Baseline: Group 1 and 2 ]
  26. Assessment of fear of hypoglycemia with the FH-15 [ Time Frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b) ]
  27. 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) ]
  28. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790645


Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Ministerio de Economía y Competitividad, Spain
Andaluz Health Service
Roche Pharma AG
Investigators
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Principal Investigator: Soledad Ruiz de Adana, MD, PhD Andaluz Health Service

Publications:
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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT02790645     History of Changes
Other Study ID Numbers: CSII TELEMEDICINE PROGRAM
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: February 2016

Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
Type 1 diabetes
Health technologies
Continuous subcutaneous insulin infusion
Telemedicine
Glycemic variability
Inflammatory markers,
Oxidative stress
Depression
Quality of life
Cost-effectiveness

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases