Telemedicine Program in Type 1 Diabetes and CSII

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

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: Group 2b. Control; Other: Group 2a. Telemedicine program; Other: Group 1b.Telemedicine program; Other: Group 1a. Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02790645

CSII TELEMEDICINE PROGRAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 4 patient groups

Group 1a. Control

Other group

Description:

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

Treatment:

Other: Group 1a. Control

Group 2a. Telemedicine program

Other group

Description:

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

Treatment:

Other: Group 2a. Telemedicine program

Group 1b. Telemedicine program

Other group

Description:

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).

Treatment:

Other: Group 1b.Telemedicine program

Group 2b. Control

Other group

Description:

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

Treatment:

Other: Group 2b. Control