Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes

NCT ID: NCT01688778

Last Updated: 2018-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-04-28

Brief Summary

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The aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine.

Detailed Description

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Type-2-diabetes is a growing healthcare problem. Both because of the increasing amount of patients and because of the complications of diabetes.

Non-pharmacological treatment is considered fundamental in the treatment of patients with type-2-diabetes.

In the Community of Copenhagen, all patients diagnosed with diabetes receive rehabilitation. The rehabilitation consists of counseling with regards to nutrition, physical activity, smoking cessation and education about diabetes.

Some patients however, remain poorly regulated despite rehabilitation as well as pharmacological treatment.

A total number of 165 patients will be randomized to intervention group or standard care.

Conditions

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Type 2 Diabetes Poor Glycemic Control Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telemedicine

Monthly video consultations with a nurse as add-on to standard treatment.

Group Type EXPERIMENTAL

Telemedicine

Intervention Type BEHAVIORAL

Monthly video consultations with a nurse as add-on to standard treatment. The nurse has access to bloodsugar- bloodpressure and weight measurements uploaded by the participants to a tablet computer directly from the devices.

Patients on Insulin measure bloodsugar twice a day (fasting and before their evening meal). Patients not on Insulin measure bloodsugar once a week (fasting and before their evening meal). All participants measure bloodpressure and weight once a week. The intervention lasts 32 weeks.

Standard treatment

Standard diabetes control at a Diabetes Clinic or GP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemedicine

Monthly video consultations with a nurse as add-on to standard treatment. The nurse has access to bloodsugar- bloodpressure and weight measurements uploaded by the participants to a tablet computer directly from the devices.

Patients on Insulin measure bloodsugar twice a day (fasting and before their evening meal). Patients not on Insulin measure bloodsugar once a week (fasting and before their evening meal). All participants measure bloodpressure and weight once a week. The intervention lasts 32 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* HbA1c \> 7,5%
* BMI \> 25
* Spoken danish
* Completed a rehabilitation program more than 6 months ago

Exclusion Criteria

* HbA1c \< 7,5%
* BMI \< 25
* Need of interpreter
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Health and Care Committee, Copenhagen City Council

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Caroline Raun Hansen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caroline Raun Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark

Locations

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Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Site Status

Countries

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Denmark

References

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Hansen CR, Perrild H, Koefoed BG, Zander M. Video consultations as add-on to standard care among patients with type 2 diabetes not responding to standard regimens: a randomized controlled trial. Eur J Endocrinol. 2017 Jun;176(6):727-736. doi: 10.1530/EJE-16-0811. Epub 2017 Mar 21.

Reference Type DERIVED
PMID: 28325823 (View on PubMed)

Hansen CR, Perrild H, Koefoed BG, Faurschou P, Host D, Zander M. Effects of telemedicine in the treatment of patients with type 2 diabetes--a study protocol. Dan Med J. 2013 Dec;60(12):A4743.

Reference Type DERIVED
PMID: 24355450 (View on PubMed)

Other Identifiers

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H-2-2011-158

Identifier Type: -

Identifier Source: org_study_id

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