Type1 Diabetes MellitusPOWER2DMECNCT03588104
"POWER2DM Evaluation Campaign"
A study testing POWER2DM system in people with Type1 Diabetes Mellitus and Type2 Diabetes Mellitus, run by Leiden University Medical Center at 2 sites in 2 countries.
Trial summary
Rationale: Hyperglycaemia is an important cause of long-term macro-and microvascular complications in all patients with diabetes mellitus. However, only a small fraction of the patients with diabetes reaches the set target of glycemic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type1 Diabetes Mellitus, Type2 Diabetes Mellitus, Diabetes Mellitus
- What is being tested?
- POWER2DM system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Dec 2018to 31 Dec 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
- Diagnosed T2DM or T1DM
- Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher)
Who cannot join
- Severe renal insufficiency (eGFR<30ml/min)
- Serious/severe comorbidity that interferes with diabetes outcomes or diabetes self-management including but not limited to: psychiatric diseases, chronic hepatopathy, active malignancy, chronic obstructive pulmonary disease (COPD), disease of the digestive tract, endocrine disorders, cerebrovascular disease with disability
- For female participants: pregnancy or wanting to become pregnant in the coming 9 months
- Concurrent participation in other clinical trials
- Any other situation in which the investigator identifies a potential risk of not being able to perform the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Leiden University Medical Centre
Leiden, South Holland, 2333 ZA
About this study
Official title: Evaluation of the POWER2DM Diabetes Self-Management Support System Compared With Usual Care for Patients With Diabetes
Rationale: Hyperglycaemia is an important cause of long-term macro-and microvascular complications in all patients with diabetes mellitus. However, only a small fraction of the patients with diabetes reaches the set target of glycemic control. Problems with adequate self-management usually underlie problems to maintain glycaemic control. Thus, patients need more support in order to reduce the burden and increase the effectiveness of their diabetes self-management. One way to do this is by using integrated technologies and personalized plans for diabetes care. For this purpose, the POWER2DM support system was developed to give patients insight into their condition and support diabetes patients and their health care professionals in setting and achieving self-management goals using predictive computer model simulations and behavioural action plans.
Objective: To provide proof of concept that POWER2DM is safe and effective in improving glycaemic control, improving behavioural/psychosocial and lifestyle markers, and to assess the cost-effectiveness of the approach and to highlight any potential issues that may impede implementation.
Read more
Study design: This is a pragmatic randomised controlled trial with 9 months follow-up in which patients will be randomised 1:1 to either Power2DM support (Power2DM group) or usual care (usual care group). There will be evaluation moments at baseline, after 11 weeks, 22 weeks and 37 weeks.
Study population: 230 patients with diabetes (N=115 type 1 diabetes (T1D), N=115 type 2 diabetes (T2D)) recruited from out-patient clinics in the Netherlands (Leiden University Medical Centre and affiliating teaching hospitals N=115) and Córdoba, Spain (Reina Sofia University Hospital N=115).
Intervention: The POWER2DM support group will receive access to the prototype 2 of the POWER2DM system. This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry.
Main study parameters/endpoints: Change in glucose regulation as measured by %HbA1c before and after the intervention compared between the intervention and control group.
- Conditions
- Type1 Diabetes Mellitus, Type2 Diabetes Mellitus, Diabetes Mellitus, Health Behavior, Self Efficacy
- Being tested
- POWER2DM system, Usual care
- Keywords
- Electronic Health (eHealth)
- Medical subject headings
- Diabetes Mellitus, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWER2DM systemDevice
This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry. Power2DM support will be provided as an adjunct to usual care
Usual careOther
Usual care as given to diabetes patients by the patient's diabetes care team.
| Study group | Role | What they receive |
|---|---|---|
| POWER2DM support group | Experimental | Participants in this group will receive access to the POWER2DM system as an adjunct to usual care. The participants have three intervention visits in which they will use the Shared Decision Making Dashboard to set self-management goals and will use the Self-Management Support system for trying to reach those goals in the periods after the intervention visits. Receives: Device: POWER2DM system |
| Usual care group | Active comparator | Participants in this group will follow their usual diabetes care with their own diabetes care team. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic control
Change in HbA1c before and after the intervention compared between the intervention and control group
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Secondary outcomes (28)
Amount hypoglycemia
Amount of hypoglycemia measured by time spent in hypoglycaemia before and after treatment in the Power2DM group compared to the usual care control group
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Hypo unawareness
Hypo unawareness as measured by Clarke's hypo unawareness questionnaire, before and after treatment in the Power2DM group compared to the usual care control group
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Incidence of adverse events
Incidence of adverse events occurring during the study period including serious hypoglycemic events
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Mean blood glucose (MBG)
As derived from continuous glucose measurements by a flash glucose monitoring (FGM) device
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Standard deviation of MBG (SDBG)
As derived from continuous glucose measurements by a FGM device
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Largest amplitude of glycemic excursions (LAGE)
As derived from continuous glucose measurements by a FGM device
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Mean amplitude of glycemic excursions (MAGE)
As derived from continuous glucose measurements by a FGM device
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Absolute means of daily differences (MODD)
As derived from continuous glucose measurements by a FGM device
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Time spent in range
As derived from continuous glucose measurements by a FGM device
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
ADVANCE Cardiovascular risk
The ADVANCE Cardiovascular Risk Engine, calculates the risk of major cardiovascular disease in patients with type 2 diabetes for the next 4 years (range 0-100%). This is defined as fatal or non-fatal myocardial infarction, stroke or cardiovascular death.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
ADVANCE Kidney disease Risk
The ADVANCE Kidney Risk Engine, calculates the risk of new-onset albuminuria and major kidney-related events in patients with type 2 diabetes for the next 5 years (range 0-100%). Major kidney-related events are defined as doubling of serum creatinin to >2.26mg/dL, renal replacement therapy, or renal death.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Major Outcomes T1D
The Major Outcomes T1D risk score assess the 3, 5 and 7 year risk of a patient with type 1 diabetes on major outcomes (range 0-100%). These outcomes included major coronary heart disease, stroke, end-stage renal failure, amputations, blindness and all-cause death.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
UKPDS risk score
The UKPDS risk score calculated the risk a patient with type 2 diabetes will develop coronary heart disease, fatal coronary hear disease, stroke or fatal stroke (range 0-100%)
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Q score
The Q score is a single metric for a continuous glucose monitoring (CGM) profile which summarize the glucose profile using five factors: central tendency, hyperglycemia, hypoglycemia, intra- and inter daily variations.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Amount of steps
Average amount of steps per day over a week measured by a step counter
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Self-reported exercise time
Exercise time per week as reported in the POWER2DM system
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Frequency of self-monitoring of blood glucose (SMBG) measurements
Frequency of SMBG measurements as reported by the glucose measurement device
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Self-reported adherence to medication plan
Self-reported adherence to medication plan as reported in the POWER2DM system
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Weight
Weight in kilograms measured on a scale
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Body mass index (BMI)
BMI in kg/m2, computed from height and weight
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Diabetes Self-Management Questionnaire Revised (DSMQ-R)
Subscales: Glucose Management, Dietary Control, Physical Activity, Health Care Use Transformed scale scores can vary between 0-10, with higher scores indicating more effective self-care
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Patient utilities by EQ-5D
No subscales: EQ-5D provides a general health index with higher scores indicating better general health. QALYs will be calculated from EQ-5D scores.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Problem Areas in Diabetes (PAID)
The PAID provides a total diabetes distress score (0-100), with higher scores (> 40) indicating more distress.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9)
WHO-5 provides a total score (0-100) with higher scores indicating better wellbeing, PHQ-9 provides a total score (1-27) indicating a likelihood of depression, with higher scores indicating more depressive symptoms
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Technology Acceptance Questionnaire (TAQ)
The TAQ provides scores (1-7) on the following domains: Performance expectancy, Effort expectancy, Social influence, Facilitating conditions, Affect, Self-efficacy, Trust, Motivation and Behavioural intention. Higher scores indicate better acceptance of the system.
Measured: 5 weeks and 37 weeks
Cost-effectiveness
Costs/quality adjusted life years (QALYs) Costs assessed via cost questionnaire and medication registry. QALYs based on patient utilities measured via EQ5D.
Measured: Over 37 weeks
Stress by perceived Stress Scale (PSS)
The PSS provides a total perceived stress score (0-40), with higher scores indicating more perceived stress.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Patient Assessment of Chronic Illness Care (PACIC)
The PACIC measures the patient's perception of the care that they receive.
Measured: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start3 Dec 2018
- Primary completion31 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomised trial
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Andaluz Health Service
- Responsible party
- Principal investigator, JKSont, Leiden University Medical Center
- Investigators
- Jacob Sont, Ph.D., Principal investigator, Leiden University Medical CenterJavier Delgado Lista, MD Ph.D., Principal investigator, Andaluz Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588104
- Sponsor's protocol ID
- P17.280
- Acronym
- POWER2DMEC
- Status last verified
- Mar 2024
- First submitted
- 28 May 2018
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruissen MM, Torres-Pena JD, Uitbeijerse BS, Arenas de Larriva AP, Huisman SD, Namli T, Salzsieder E, Vogt L, Ploessnig M, van der Putte B, Merle A, Serra G, Rodriguez G, de Graaf AA, de Koning EJP, Delgado-Lista J, Sont JK; POWER2DM Consortium. Clinical impact of an integrated e-health system for diabetes self-management support and shared decision making (POWER2DM): a randomised controlled trial. Diabetologia. 2023 Dec;66(12):2213-2225. doi: 10.1007/s00125-023-06006-2. Epub 2023 Sep 29.
PubMed 37775611
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the POWER2DM Diabetes Self-Management Support System Compared With Usual Care for Patients With Diabetes
- ClinicalTrials.gov ID
- NCT03588104
- Acronym / sponsor ID
- POWER2DMEC / P17.280
- Conditions
- Type1 Diabetes Mellitus, Type2 Diabetes Mellitus, Diabetes Mellitus, Health Behavior, Self Efficacy
- Keywords
- Electronic Health (eHealth)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Andaluz Health Service
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Jul 2018 (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.
Rationale: Hyperglycaemia is an important cause of long-term macro-and microvascular complications in all patients with diabetes mellitus. However, only a small fraction of the patients with diabetes reaches the set target of glycemic control. Problems with adequate self-management usually underlie problems to maintain glycaemic control. Thus, patients need more support in order to reduce the burden and increase the effectiveness of their diabetes self-management. One way to do this is by using integrated technologies and personalized plans for diabetes care. For this purpose, the POWER2DM support system was developed to give patients insight into their condition and support diabetes patients and their health care professionals in setting and achieving self-management goals using predictive computer model simulations and behavioural action plans.
Objective: To provide proof of concept that POWER2DM is safe and effective in improving glycaemic control, improving behavioural/psychosocial and lifestyle markers, and to assess the cost-effectiveness of the approach and to highlight any potential issues that may impede implementation.
Study design: This is a pragmatic randomised controlled trial with 9 months follow-up in which patients will be randomised 1:1 to either Power2DM support (Power2DM group) or usual care (usual care group). There will be evaluation moments at baseline, after 11 weeks, 22 weeks and 37 weeks.
Study population: 230 patients with diabetes (N=115 type 1 diabetes (T1D), N=115 type 2 diabetes (T2D)) recruited from out-patient clinics in the Netherlands (Leiden University Medical Centre and affiliating teaching hospitals N=115) and Córdoba, Spain (Reina Sofia University Hospital N=115).
Intervention: The POWER2DM support group will receive access to the prototype 2 of the POWER2DM system. This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry.
Main study parameters/endpoints: Change in glucose regulation as measured by %HbA1c before and after the intervention compared between the intervention and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic randomised trial
| Arm | Type | Receives |
|---|---|---|
| POWER2DM support group | Experimental | Device: POWER2DM systemParticipants in this group will receive access to the POWER2DM system as an adjunct to usual care. The participants have three intervention visits in which they will use the Shared Decision Making Dashboard to set self-management goals and will use the Self-Management Support system for trying to reach those goals in the periods after the intervention visits. |
| Usual care group | Active comparator | Other: Usual careParticipants in this group will follow their usual diabetes care with their own diabetes care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed T2DM or T1DM
- Able to self-monitor and work with computer and smart phone with internet connections (as assessed by researcher)
Key exclusion criteria (5 listed)
- Severe renal insufficiency (eGFR<30ml/min)
- Serious/severe comorbidity that interferes with diabetes outcomes or diabetes self-management including but not limited to: psychiatric diseases, chronic hepatopathy, active malignancy, chronic obstructive pulmonary disease (COPD), disease of the digestive tract, endocrine disorders, cerebrovascular disease with disability
- For female participants: pregnancy or wanting to become pregnant in the coming 9 months
- Concurrent participation in other clinical trials
- Any other situation in which the investigator identifies a potential risk of not being able to perform the study.
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 |
|---|---|---|
| POWER2DM systemThis system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry. Power2DM support will be provided as an adjunct to usual care | Device | POWER2DM support group |
| Usual careUsual care as given to diabetes patients by the patient's diabetes care team. | Other | Usual care group |
Primary outcome
Change in glycemic control
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Change in HbA1c before and after the intervention compared between the intervention and control group
28 secondary outcomes
Amount hypoglycemia
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Hypo unawareness
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Incidence of adverse events
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Mean blood glucose (MBG)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Standard deviation of MBG (SDBG)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Largest amplitude of glycemic excursions (LAGE)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Mean amplitude of glycemic excursions (MAGE)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Absolute means of daily differences (MODD)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Time spent in range
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
ADVANCE Cardiovascular risk
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
ADVANCE Kidney disease Risk
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Major Outcomes T1D
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
UKPDS risk score
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Q score
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Amount of steps
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Self-reported exercise time
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Frequency of self-monitoring of blood glucose (SMBG) measurements
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Self-reported adherence to medication plan
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Weight
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Body mass index (BMI)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Diabetes Self-Management Questionnaire Revised (DSMQ-R)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Patient utilities by EQ-5D
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Problem Areas in Diabetes (PAID)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Mood/Well-being by WHO-5 and Patient Health Questionnaire (PHQ-9)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Technology Acceptance Questionnaire (TAQ)
Time frame: 5 weeks and 37 weeks
Cost-effectiveness
Time frame: Over 37 weeks
Stress by perceived Stress Scale (PSS)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks
Patient Assessment of Chronic Illness Care (PACIC)
Time frame: 0 weeks, 11 weeks, 22 weeks and 37 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 13 Mar 2024.
- Derived from this study: PubMed 37775611Ruissen MM, Torres-Pena JD, Uitbeijerse BS, Arenas de Larriva AP, Huisman SD, Namli T, Salzsieder E, Vogt L, Ploessnig M, van der Putte B, Merle A, Serra G, Rodriguez G, de Graaf AA, de Koning EJP, Delgado-Lista J, Sont JK; POWER2DM Consortium. Clinical impact of an integrated e-health system for diabetes self-management support and shared decision making (POWER2DM): a randomised controlled trial. Diabetologia. 2023 Dec;66(12):2213-2225. doi: 10.1007/s00125-023-06006-2. Epub 2023 Sep 29.
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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.
Jacob Sont, Ph.D. principal investigator
Leiden University Medical Center
Javier Delgado Lista, MD Ph.D. principal investigator
Andaluz Health Service
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWER2DM system in people with Type1 Diabetes Mellitus and Type2 Diabetes Mellitus, run by Leiden University Medical Center at 2 sites in 2 countries.
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 2 inclusion and 5 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Spain. 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?
Change in glycemic control (time frame: 0 weeks, 11 weeks, 22 weeks and 37 weeks). 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 NCT03588104, which also lists 1 linked publication.
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 13 Mar 2024.