Type 2 DiabetesNCT01688778
Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes
A study testing Telemedicine in people with Type 2 Diabetes and Poor Glycemic Control, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Poor Glycemic Control, Medication Adherence
- What is being tested?
- Telemedicine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2012to 28 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c > 7,5%
- BMI > 25
- Spoken danish
- Completed a rehabilitation program more than 6 months ago
Who cannot join
- HbA1c < 7,5%
- BMI < 25
- Need of interpreter
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Endocrine Section, Dept. of Internal Medicine I, Bispebjerg Hospital
Copenhagen, Copenhagen NV, DK-2400
About this study
Official title: The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes
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.
Read the detailed description
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
- Type 2 Diabetes, Poor Glycemic Control, Medication Adherence
- Being tested
- Telemedicine
- Keywords
- Type 2 diabetes, Quality of life, Lifestyle intervention, Telemedicine, Videoconference
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Monthly video consultations with a nurse as add-on to standard treatment. Receives: Behavioral: Telemedicine |
| Standard treatment | No intervention | Standard diabetes control at a Diabetes Clinic or GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c
Measured: Baseline, 16 weeks, 32 weeks, 6 months after intervention
Secondary outcomes (10)
Fasting total cholesterol, LDL, HDL, triglycerides
Measured: Baseline, 32 weeks
Beta-cell function test (HOMA)
Measured: Baseline, 32 weeks
Weight
Measured: Baseline, 32 weeks
Bloodpressure
Measured: Baseline, 32 weeks
Physical activity
Measured: Baseline, 32 weeks
Change in quality of life
Measured: Baseline, 32 weeks
Waist circumference
Measured: Baseline, 32 weeks
Hip circumference
Measured: Baseline, 32 weeks
Body mass index
Measured: Baseline, 32 weeks
Use of medication
Measured: Baseline, 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startJun 2012
- Primary completion28 Apr 2015
- Study completion28 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Health and Care Committee, Copenhagen City Council
- Responsible party
- Principal investigator, Caroline Raun Hansen, Bispebjerg Hospital
- Investigators
- Caroline Raun Hansen, MD, Principal investigator, Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688778
- Sponsor's protocol ID
- H-2-2011-158
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2012
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28325823Hansen 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.
PubMed 24355450
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01688778
- Acronym / sponsor ID
- H-2-2011-158
- Conditions
- Type 2 Diabetes, Poor Glycemic Control, Medication Adherence
- Keywords
- Type 2 diabetes, Quality of life, Lifestyle intervention, Telemedicine, Videoconference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Health and Care Committee, Copenhagen City Council
- Study start
- Jun 2012
- Primary completion
- 28 Apr 2015 (actual)
- Study completion
- 28 Apr 2015 (actual)
- First posted
- 20 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Behavioral: TelemedicineMonthly video consultations with a nurse as add-on to standard treatment. |
| Standard treatment | No intervention | –Standard diabetes control at a Diabetes Clinic or GP |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HbA1c > 7,5%
- BMI > 25
- Spoken danish
- Completed a rehabilitation program more than 6 months ago
Key exclusion criteria (3 listed)
- HbA1c < 7,5%
- BMI < 25
- Need of interpreter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineMonthly 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. | Behavioural | Telemedicine |
Primary outcome
Changes in HbA1c
Time frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention
10 secondary outcomes
Fasting total cholesterol, LDL, HDL, triglycerides
Time frame: Baseline, 32 weeks
Beta-cell function test (HOMA)
Time frame: Baseline, 32 weeks
Weight
Time frame: Baseline, 32 weeks
Bloodpressure
Time frame: Baseline, 32 weeks
Physical activity
Time frame: Baseline, 32 weeks
Change in quality of life
Time frame: Baseline, 32 weeks
Waist circumference
Time frame: Baseline, 32 weeks
Hip circumference
Time frame: Baseline, 32 weeks
Body mass index
Time frame: Baseline, 32 weeks
Use of medication
Time frame: Baseline, 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Derived from this study: PubMed 28325823Hansen 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.
- Derived from this study: PubMed 24355450Hansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Raun Hansen, MD principal investigator
Endocrine Section, Bispebjerg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Type 2 Diabetes and Poor Glycemic Control, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c (time frame: Baseline, 16 weeks, 32 weeks, 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688778, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.