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OpenTrials
Completed

NCT Number: NCT03353376

Group Versus Individual Care in Diabetes Clinic

In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Group Meetings Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of type 1 or type 2 diabetes
  • Fluency in Hebrew
  • Attendance at least for the second time at the diabetes clinic
  • Follow up of at least one year by a general practitioner
  • Willingness to participate in the study and to give informed consent.

Exclusion criteria

  • Uncontrolled psychiatric diseases
  • Active cancer
  • Pregnancy

Treatment and study plan

group care with Empowerment model

Behavioral

Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment

Primary outcomes

  1. change in in Hba1c levels

    Time frame: one year from date of randomization

    Collection of data at start and after one year

Secondary outcomes

  1. change in scores of diabetes specific questionnaire

    Time frame: one year from date of randomization

    Collection of data at start and end of study from electronic files

  2. change in BMI in kg/m2

    Time frame: one year from date of randomization

    Collection of data (weight in kg, height in meter) at start and end of study from electronic files

  3. change in non HDL Cholesterol

    Time frame: one year from date of randomization

    Collection of data at start and end of study from electronic files

Other outcomes

  1. change in number of outpatients visits

    Time frame: one year from date of randomization

    Collection of data at start and after one year

  2. change in number in hospital admission

    Time frame: one year from date of randomization

    Collection of data at start and end of study from electronic files

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Group Versus Individual Care in Patients With Long Standing Type 1 and Type 2 Diabetes: Non Inferiority in a One Year Prospective Study in a Tertiary Diabetes Clinic

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2017
Registry last updated
Nov 27, 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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