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CompletedNCT02790645Updated Jul 13, 2017

Telemedicine Program in Type 1 Diabetes and CSII

An interventional study of Group 2a. Telemedicine program and Group 1a. Control in Diabetes Mellitus, Type 1, sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Completed. Open to participants aged 16 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-07-13.

Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
16 Years to 85 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Diabetes Mellitus, Type 1

Keywords

  • Type 1 diabetes
  • Health technologies
  • Continuous subcutaneous insulin infusion
  • Telemedicine
  • Glycemic variability
  • Inflammatory markers,
  • Oxidative stress
  • Depression
  • Quality of life
  • Cost-effectiveness
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 51 is below the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Other
    Group 1a. Control

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

    Other: Group 1a. Control

  • 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

  • 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

  • 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

Interventions

  • OtherGroup 2a. Telemedicine program

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

  • OtherGroup 1a. Control

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

  • OtherGroup 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).

  • OtherGroup 2b. Control

    After a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months) .

06

What researchers measure

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)

07

Study locations

No study locations are listed for this record.

08

References and documents

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 16621113 ↗
  • Blanchet 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02790645
Lead sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborators
Ministerio de Economía y Competitividad, Spain, Andaluz Health Service, Roche Pharma AG
Responsible party
Sponsor
First posted
Jun 6, 2016
Start date
Sep 2012
Primary completion
Apr 2016
Completion
Sep 19, 2016
Last update
Jul 13, 2017

Study contacts

Soledad Ruiz de Adana, MD, PhD
principal investigator · Andaluz Health Service

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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