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NCT Number: NCT02790645

Telemedicine Program in Type 1 Diabetes and CSII

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Behavior Behavioral Symptoms Depression Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Group 2a. Telemedicine program

Other

CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).

Group 1a. Control

Other

Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months).

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).

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) .

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Collaborators

  • Andaluz Health Service
  • Ministerio de Economía y Competitividad, Spain
  • Roche Pharma AG

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2016
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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