Type1 Diabetes MellitusNCT03202732
DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes
A study testing DiabetesFlex in people with Type1 Diabetes Mellitus, run by Annesofie Lunde Jensen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- DiabetesFlex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Oct 2017to 25 Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years Have had T1DM for more than 1 years Be able to use the Danish-language general website on healthcare www.sundhed.dk Be mentally well functioning Understand and read Danish Access to internet
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study
The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.
The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.
Read the detailed description
Diabetes Mellitus (DM) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. The is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with T1DM.
The use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.
The study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- DiabetesFlex
- Keywords
- Self-management, Patient Activeted measure, Patient-reported outcome, Type 1 diabetes Mellitus, Non-inferiority study
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiabetesFlexOther
DiabetesFlex consist of one mandatory and two optional consultations. Before the consultations patients receive the AmbuFlex Diabetes questionnaire.
The AmbuFlex Diabetes questionnaire is based on both validated questionnaires and clinical consensus. The AmbuFlex Diabetes questionnaire consists of: SF36 well-being question, WHO-5 Well-being Index. Questions concerning: HgA1c, home-based blood pressure monitoring, incidents of hypoglycemia, diabetes complications, regular eye check, regular food check, erectile dysfunction and peripheral neuropathy, The PAID scale, Topics patients may want to talk with the health care professional about, the patient's evaluation of the need for diabetes care. View the AmbuFlex Diabetes questionnaire at the homepage: www.diabetesflex.auh.dk.
| Study group | Role | What they receive |
|---|---|---|
| DiabetesFlex | Other | In DiabetesFlex intervention, patients are offered 3 consultations/year. One mandatory consultations (30 minutes). The patient, an endocrinologist and a diabetes nurse attend.
Two optional consultations, patients can choose between face-to-face consultations, a telephone consultation or to cancel the consultation.
Ahead of the consultations, patients fill out the AmbuFlex Diabetes questionnaire and deliver a blood and urine sample.
Based on the patient's response to the AmbuFlex Diabetes questionnaire, the result of the blood sample and the urine sample, the diabetes nurse assign the patient to a face-to-face consultation, a telephone consultation or no consultation with an endocrinologist, a diabetes nurse or a dietician. Receives: Other: DiabetesFlex |
| Standard care | No intervention | Standard diabetes care consists of 3 consultations (15 minutes)/year with a physician or a diabetes nurse by turns. Ahead of the consultation patients send in a blood sample for measuring HgA1c, urine sample for measuring urin-albumin creatinin ratio and other blood samples depending of arrangements made in the last consultation. Once a year in relation to a consultation, patients fill in the Problem Area In Diabetes (PAID) (20) scale together. Furthermore, based on the patients or healthcare professional judgement, patients see a dietician when needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Non-inferiority with respect to HbA1c
Measured: 15 mounth
Secondary outcomes (10)
General health will be assessed by items from the SF-36 questionnaire
General health will be measured at baseline and after 15 mounth
Measured: 15 mounth
Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)
Health literacy will be measured at baseline and after 15 months.
Measured: 15 mounth
Well-being will be assessed by the WHO-5 Well-being Index
Well-being will be measured at baseline and after 15 months.
Measured: 15 mounth
Patient Activated Measure (PAM)
Patient Activated Measure (PAM) will be measured at baseline and after 15 months.
Measured: 15 mounth
"Generic questions concerning patient involvement" is validate by "DEFACTUM"
Patient involvement will be measured at baseline and after 15 months.
Measured: 15 mounth
The problem Areas In Diabetes Scale (PAID)
PAID will be measured at baseline and after 15 months.
Measured: 15 mounth
Blood pressure
Blood pressure will be measured at baseline and after 15 months.
Measured: 15 mounth
Urine albumine/creatinine ratio
urine albumine/creatinine ratio will be measured at baseline and after 15 months.
Measured: 15 mounth
Number and type consultations
Consultations consists of face-to-face, telephone, cancel, registered non-attendance and health care professional involved in the consultation will be measured after 15 mounth
Measured: 15 mounth
Mortality
Mortality will be measured after 15 months.
Measured: 15 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start9 Oct 2017
- Primary completion20 Aug 2020
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies 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
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annesofie Lunde Jensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Annesofie Lunde Jensen, Aarhus University Hospital
- Investigators
- Annesofie L. Jensen, Postdoc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202732
- Sponsor's protocol ID
- DiabetesFlex2017
- Status last verified
- Nov 2020
- First submitted
- 27 Jun 2017
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study
- ClinicalTrials.gov ID
- NCT03202732
- Acronym / sponsor ID
- DiabetesFlex2017
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- Self-management, Patient Activeted measure, Patient-reported outcome, Type 1 diabetes Mellitus, Non-inferiority study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Annesofie Lunde JensenUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 29 Jun 2017 (actual)
- 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 this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.
The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.
Detailed description
Diabetes Mellitus (DM) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. The is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with T1DM.
The use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.
The study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DiabetesFlex | Other | Other: DiabetesFlexIn DiabetesFlex intervention, patients are offered 3 consultations/year. One mandatory consultations (30 minutes). The patient, an endocrinologist and a diabetes nurse attend. Two optional consultations, patients can choose between face-to-face consultations, a telephone consultation or to cancel the consultation. Ahead of the consultations, patients fill out the AmbuFlex Diabetes questionnaire and deliver a blood and urine sample. Based on the patient's response to the AmbuFlex Diabetes questionnaire, the result of the blood sample and the urine sample, the diabetes nurse assign the patient to a face-to-face consultation, a telephone consultation or no consultation with an endocrinologist, a diabetes nurse or a dietician. |
| Standard care | No intervention | –Standard diabetes care consists of 3 consultations (15 minutes)/year with a physician or a diabetes nurse by turns. Ahead of the consultation patients send in a blood sample for measuring HgA1c, urine sample for measuring urin-albumin creatinin ratio and other blood samples depending of arrangements made in the last consultation. Once a year in relation to a consultation, patients fill in the Problem Area In Diabetes (PAID) (20) scale together. Furthermore, based on the patients or healthcare professional judgement, patients see a dietician when needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age over 18 years Have had T1DM for more than 1 years Be able to use the Danish-language general website on healthcare www.sundhed.dk Be mentally well functioning Understand and read Danish Access to internet
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DiabetesFlexDiabetesFlex consist of one mandatory and two optional consultations. Before the consultations patients receive the AmbuFlex Diabetes questionnaire. The AmbuFlex Diabetes questionnaire is based on both validated questionnaires and clinical consensus. The AmbuFlex Diabetes questionnaire consists of: SF36 well-being question, WHO-5 Well-being Index. Questions concerning: HgA1c, home-based blood pressure monitoring, incidents of hypoglycemia, diabetes complications, regular eye check, regular food check, erectile dysfunction and peripheral neuropathy, The PAID scale, Topics patients may want to talk with the health care professional about, the patient's evaluation of the need for diabetes care. View the AmbuFlex Diabetes questionnaire at the homepage: www.diabetesflex.auh.dk. | Other | DiabetesFlex |
Primary outcome
HbA1c
Time frame: 15 mounth
Non-inferiority with respect to HbA1c
10 secondary outcomes
General health will be assessed by items from the SF-36 questionnaire
Time frame: 15 mounth
Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)
Time frame: 15 mounth
Well-being will be assessed by the WHO-5 Well-being Index
Time frame: 15 mounth
Patient Activated Measure (PAM)
Time frame: 15 mounth
"Generic questions concerning patient involvement" is validate by "DEFACTUM"
Time frame: 15 mounth
The problem Areas In Diabetes Scale (PAID)
Time frame: 15 mounth
Blood pressure
Time frame: 15 mounth
Urine albumine/creatinine ratio
Time frame: 15 mounth
Number and type consultations
Time frame: 15 mounth
Mortality
Time frame: 15 mounth
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 6 Nov 2020.
- Homepage which descrip the intervention DiabetesFlexLink provided by the sponsor.
- 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.
Annesofie L. Jensen, Postdoc principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiabetesFlex in people with Type1 Diabetes Mellitus, run by Annesofie Lunde Jensen 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 1 inclusion and 0 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 6 Nov 2020. 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?
HbA1c (time frame: 15 mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2020.