NCT02790645

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2016

Completed
Last Updated

July 13, 2017

Status Verified

February 1, 2016

Enrollment Period

3.6 years

First QC Date

February 9, 2016

Last Update Submit

July 12, 2017

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetesHealth technologiesContinuous subcutaneous insulin infusionTelemedicineGlycemic variabilityInflammatory markers,Oxidative stressDepressionQuality of lifeCost-effectiveness

Outcome Measures

Primary Outcomes (2)

  • Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).

    Baseline: Group 1 and 2

  • Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).

    6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)

Secondary Outcomes (28)

  • Assessment of inflammatory markers (hs-CRP).

    Baseline: Group 1 and 2

  • Assessment of inflammatory markers (IL-6).

    Baseline: Group 1 and 2

  • Assessment of inflammatory markers (TNF-α).

    Baseline: Group 1 and 2

  • Assessment of inflammatory markers (MCP-1).

    Baseline: Group 1 and 2

  • Assessment of inflammatory markers (hs-CRP).

    6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)

  • +23 more secondary outcomes

Study Arms (4)

Group 1a. Control

OTHER

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

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).

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).

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).

Other: Group 2b. Control

Interventions

Group 2a. Telemedicine programOTHER

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

Group 2a. Telemedicine program
Group 1a. ControlOTHER

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

Group 1a. Control
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 1b. Telemedicine program
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) .

Group 2b. Control

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 16621113BACKGROUND

  • 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.

    PMID: 18954243BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Depression

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Soledad Ruiz de Adana, MD, PhD

    Andaluz Health Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

June 6, 2016

Study Start

September 1, 2012

Primary Completion

April 1, 2016

Study Completion

September 19, 2016

Last Updated

July 13, 2017

Record last verified: 2016-02