Individually Tailored Treatment of Type 2 Diabetes

NCT02015130 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2246

Last updated 2017-09-19

No results posted yet for this study

Summary

The prevalence of Type 2 diabetes (T2D) is rising rapidly worldwide. In Denmark approximately 8% of adults have T2D and more than 25.000 are diagnosed each year. This has vast consequences for society and the patient.

Standardized treatment aiming at normalizing blood glucose and hypertension comparable to healthy individuals, have been tested in large studies. The effect on cardiovascular disease and other complications have been modest at best and one study showed an increased mortality with intensive treatment. The standardized treatment often results in polypharmacy, which increases the risk of patients discontinuing treatment.

We propose a new approach to treatment of T2D, where the patients' individual characteristics are considered. The aetiology of the diabetes can be different, which warrants different treatment. Many patients have concomitant illness which can affect the way the patient is treated. A tight regulation of blood glucose can in some patient constitute a risk of adverse effects, especially hypoglycemia. In that sense individual targets for the treatment are important. Effective lifestyle treatment has importance for a successful outcome and we therefore offer an application that can help the patient and the physician organizing activity individually.

The objective of individual treatment is to choose the most effective medication. If a prescribed drug does not have the desired effect it should be replaced with a different drug. The overall goal is to reduce the number of substances and side-effects, but simultaneous improve treatment and reduce the incidence of cardiovascular and other diabetes-related complications. This will in turn result in improved quality of life and improved adherence to treatment.

The potential effect of individual tailored treatment of T2D is to improve the guidelines of treatment, not only to improve the patients' health, but also to reduce the socioeconomic consequences of the growing T2D prevalence

Conditions

Interventions

OTHER

Individual treatment

See detailed description

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER
  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER
  • General Practice Research Database

    collaborator OTHER_GOV
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • jacob Stidsen, MD · Odense University Hospital

  • Henning Beck-Nielsen, Dr.med, MD · Odense University Hospital

  • Jeppe Gram, MD, Phd · Esbjerg Hospital - University Hospital of Southern Denmark

  • Jan Erik Henriksen, MD, Phd · Odense University Hospital

  • Jens Nielsen, PhD · Odense University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02015130 on ClinicalTrials.gov