Diabetes Mellitus, Type 2IBIDEMNCT05346614
Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission
A study testing Lifestyle intervention in people with Diabetes Mellitus, Type 2, run by Ancora Health B.V. at 4 sites in Netherlands.
Trial summary
410 Dutch type 2 diabetes patients will be randomized using a 5:1 ratio to intervention group versus control, to a lifestyle intervention program given via a mobile application and digital platform. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 Oct 2022to 1 Mar 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes: Diagnosis of T2DM without physician defined end-organ failure
- BMI: 25 to 45 kg/m²
- Age: 18 to 75 years
- Most recent HbA1c value should be greater than 6.0% (>43 mmol/mol); if less than 6.5% (<48 mmol/mol), individuals should still be receiving anti-diabetic medication
- Tech-savvy (patients are required to be able to fully use smartphone or tablet)
- Display interest and motivation to enroll in a digital, lifestyle intervention for diabetes
Who cannot join
- Weight loss of more than five kg or greater than 10% within the past six months
- Serious co-morbidities, for example, a severe form of chronic obstructive pulmonary disease (Gold III or IV), bariatric surgery, heart failure (classes 2-4) kidney failure, or another medically determined end-stage organ failure
- Substance abuse
- Learning difficulties limiting the participation in a digital health intervention and or limiting the comprehension of trial goals or coaching curriculum.
- Current treatment with anti-obesity drugs
- Pregnancy, consideration of pregnancy within the study period, lactation or having given birth within the previous nine months
Show all 30Show fewer
- Hospital admission for depression
- Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) or use of antipsychotic drugs.
- Currently uncontrolled or eating disorder or purging behavior
- Type 1 diabetes
- History of keto-acidosis
- Myocardial infarction, stroke, angina, or coronary insufficiency within the previous six months
- Diabetic retinopathy requiring treatment
- Creatinine > 2.0 mg·dL-1 or > 152.5 µmol·L-1
- Urinary albumin > 1 g·dL-1 or > 10 g·L-1
- Cancer requiring treatment in the past five years, with the exception of non-melanoma skin cancer
- Chronic infectious disease requiring ongoing treatment
- Other chronic diseases or conditions likely to limit lifespan to less than six years
- Severe visual impairment or other impairment preventing interaction with digital content
- Non-English or Non-Dutch speaking
- Excessive alcohol intake (acute or chronic) defined as the average consumption of three or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
- Cholelithiasis or biliary dysfunction
- Use of an insulin pump
- Participation in diabetes therapy within the preceding three years; participation in concurrent weight management or interventional research protocol,
- Untreated thyroid disease,
- Requirement of a prescribed medical diet
- A recent on-record estimated glomerular filtration rate of less than 30 mL/min per 1.732 m²
- Incapacitated patients, and thus unable to fully participate in the trial.
- uncontrolled blood pressure (SBP > 170 mmHg and/or DBP > 100 mmHg)
- For nutritional ketosis specifically: impaired hepatic function (Bilirubin >2 mg·dL-1 or >34.2 µmol·L-1, Albumin < 3.5 g·dL-1 or <35 g·L-1)
Trial locations and contacts
4 sites in 1 country.
Sarah Mount, PhD contact
Netherlands4 sites
St. Anna Ziekenhuis
Eindhoven, Limburg
Arno Toorians, MD, +31 40 286 4040, a.toorians@st-anna.nl
Center Medische Kwartier Eindhoven
Eindhoven, North Brabant, 5611 NV
Elly Vogelzang, MD, +31040 211 51 79, e.vogelzang@medischkwartiereindhoven.nl
Huisartsenpraktijk Zonneoord
The Hague, South Holland, 2544 KM
Janet Kist, MD, +31070 321 4567, j.m.kist@lumc.nl
Haga Ziekenhuis
The Hague, South Holland, 2545 AA
Maarten van Aken, PhD, MD, +31070 210 0000, m.vanaken@hagaziekenhuis.nl
About this study
Official title: Digital, Blended Lifestyle Intervention Program for Remission and Improved Management of Type 2 Diabetes
410 Dutch type 2 diabetes patients will be randomized using a 5:1 ratio to intervention group versus control, to a lifestyle intervention program given via a mobile application and digital platform. Active participants will undergo diabetyping, where blood glucose and c-peptide responses to a glucose challenge are measured, and be recommended to follow a calorie-restricted (minimum 500 kcal deficit) low-carbohydrate, or restricted carbohydrate (120g) Mediterranean diet and customized exercise program for a period of 24 weeks. Individuals will then be followed for a period of 2 years following the intervention.
Read the detailed description
Patients will partake in a 24-week intervention followed by a two-year follow-up period. The intervention will consist of diabetic phenotyping (diabetyping), and a personalized app-based lifestyle intervention, done in conjunction with usual care, the so-called blended care model. Individuals will be allocated to either a high (unsaturated) fat, low-carbohydrate Mediterranean (50 g), or the Mediterranean with limited carbohydrates (120 g) diet based on their diabetype, insulin use, and personal preference. This will be given in conjunction with physical activity program, which will focus more on aerobic activity or resistance training depending on diabetype. All participants will be provided with additional coaching to support behavioral change, which will include aspects of diet, physical activity but also aspects of mindfulness, and emotion regulation. The participants will be assessed at screening, before the start of the maintenance phase, and at follow-ups one, two, and three. Control patients will follow the usual care and will also be followed up, following the same schedule. The treatment is further clarified below:
Prior to commencing the study, participants in the active intervention group will receive a kit containing all the necessary products (i.e. wearable, smart scale, and glucose monitor), information, and instructions (where applicable) for participating in the study. Moreover, they will be carefully informed about the types of personalisations available to them. The participants will have either a whole food type diet or a low carbohydrate diet recommended to them based on their metabolic profiles. In addition, they will also have specific types of exercise recommended to them. Participants' treating physicians and coaches will be informed about their choices, and will receive supporting medication adjustment documents, based on those made in previous studies. It will remain the responsibility of the treating physicians to adjust any medications the participants are receiving.
The control group is required to meet the same criteria as the intervention group. The control group only receives health assessments (with the exception of the diabetyping), and will not receive any health intervention. They will continue to receive standard diabetes care.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lifestyle intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Lifestyle coaching will be given on a digital app-based platform. Individuals will receive real-time feedback via a smart scale, activity monitor, and continuous glucose monitor (first 4 weeks, longer if required). Coaching will be focused on gradual behavior change, assisted by digital nudges, one-on-one, and small group coaching sessions. Coaching will include education regarding lifestyle to improve health literacy with respect to diet and diabetes management. Additionally, coaches will guide participants in the implementation of individualized diet and exercise program with varying levels of carbohydrate restriction and caloric deficit.
| Study group | Role | What they receive |
|---|---|---|
| Active lifestyle intervention | Experimental | Individuals in the active intervention group will undergo diabetyping (diabetes type 2 phenotyping: glucose, and C-peptide responses to a glucose challenge). Based on the diabetype, individuals will receive recommendations to follow either a calorie-restricted (500kcal deficit minimum) low carbohydrate or a modified Mediterranean diet for a period of 18 weeks (total intervention is 24 weeks). Secondly, individuals will follow a personalized exercise program. Guidance and coaching (individual and small group) will be given via mobile app and digital platform. Individuals will receive real-time feedback based on their diet, exercise, and glucose levels (via continuous glucose monitoring for 4 weeks). Medications will be slowly withdrawn over the intervention period, with a focus on the first phase of the intervention. Receives: Behavioral: Lifestyle intervention |
| Usual care group | No intervention | Individuals in the usual care group will receive standard diabetes care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of diabetes remission
Percentage of patients achieving complete diabetes remission. Diabetes remission rates amongst the active intervention group will be reported as the number of participants who have achieved fasting glucose < 7 mmol/L or HbA1c < 6.5% (48 mmol/mol) on two separate occasions 6 months apart, and glucose-lowering therapy has been stopped.
Measured: 1 year
Secondary outcomes (7)
Rates of improved glycaemic control
Percentage of patients achieving improved glycaemic control. This will be defined as the number of individuals who achieve a reduction in glycated hemoglobin (HbA1c), and or reduced dependence on glucose-lowering medications, defined as the number of medications or dose.
Measured: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Blood lipids
Changes in blood lipids, namely triglycerides, total cholesterol, LDL, and HDL will be measured as an indicator of health status
Measured: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Weight loss
Weight loss will be measured as change in weight compared to baseline. It will be measured as an indicator of participant compliance and feasibility of the program.
Measured: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Remission versus diabetype
The association between diabetype* as determined by response to an oral glucose tolerance test with remission will be determined
- de Hoogh IM, Oosterman JE, Otten W, et al. The Effect of a Lifestyle Intervention on Type 2 Diabetes Pathophysiology and Remission: The Stevenshof Pilot Study. Nutrients 2021;13(7):2193.
Measured: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Cost effectiveness
The cost of the intervention will be analyzed in comparison with that of usual care, in terms of doctor and hospital visits, as well as the use of supportive medical care ex. physiotherapy.
Measured: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Digital engagement as measured by the Engagement Index
Digital engagement will be digitally recorded as an engagement index, which is based on the frequency of user engagement with the app and digital content.
Measured: Up to 1 year
Compliance
Compliance will be assessed as a score based on the user's participation and success in coaching activities, educational sessions, and diet, physical activity and blood sugar measurement logging goals.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- This a randomized intervention study. Subjects will be randomly allocated using a 5:1 ratio between the control and intervention groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ancora Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Groningen, Universiteit Leiden, TNO
- Responsible party
- Sponsor
- Investigators
- Suzan Wopereis, PhD, Principal investigator, TNOMaarten van Aken, MD PhD, Principal investigator, Haga ZiekenhuisElly Vogelzang, MD, Principal investigator, Center Medische Kwartier EindhovenJanet Kist, MD, Principal investigator, Huisartsenpraktijk ZonneoordJan Hoogsteen, MD, Principal investigator, Ancora HealthRimke Vos, PhD, Principal investigator, Department of Public Health and Primary Care / LUMC-Campus Den Haag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346614
- Sponsor's protocol ID
- NL77688.056.21
- Acronym
- IBIDEM
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available to researchers upon motivated request. Moreover, all supporting documents will be submitted upon publication of the study protocol and results.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital, Blended Lifestyle Intervention Program for Remission and Improved Management of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05346614
- Acronym / sponsor ID
- IBIDEM / NL77688.056.21
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Ancora Health B.V.Industry (pharma, biotech, devices)
- Collaborators
- University of Groningen, Universiteit Leiden, TNO
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Apr 2022 (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.
410 Dutch type 2 diabetes patients will be randomized using a 5:1 ratio to intervention group versus control, to a lifestyle intervention program given via a mobile application and digital platform. Active participants will undergo diabetyping, where blood glucose and c-peptide responses to a glucose challenge are measured, and be recommended to follow a calorie-restricted (minimum 500 kcal deficit) low-carbohydrate, or restricted carbohydrate (120g) Mediterranean diet and customized exercise program for a period of 24 weeks. Individuals will then be followed for a period of 2 years following the intervention.
Detailed description
Patients will partake in a 24-week intervention followed by a two-year follow-up period. The intervention will consist of diabetic phenotyping (diabetyping), and a personalized app-based lifestyle intervention, done in conjunction with usual care, the so-called blended care model. Individuals will be allocated to either a high (unsaturated) fat, low-carbohydrate Mediterranean (50 g), or the Mediterranean with limited carbohydrates (120 g) diet based on their diabetype, insulin use, and personal preference. This will be given in conjunction with physical activity program, which will focus more on aerobic activity or resistance training depending on diabetype. All participants will be provided with additional coaching to support behavioral change, which will include aspects of diet, physical activity but also aspects of mindfulness, and emotion regulation. The participants will be assessed at screening, before the start of the maintenance phase, and at follow-ups one, two, and three. Control patients will follow the usual care and will also be followed up, following the same schedule. The treatment is further clarified below:
Prior to commencing the study, participants in the active intervention group will receive a kit containing all the necessary products (i.e. wearable, smart scale, and glucose monitor), information, and instructions (where applicable) for participating in the study. Moreover, they will be carefully informed about the types of personalisations available to them. The participants will have either a whole food type diet or a low carbohydrate diet recommended to them based on their metabolic profiles. In addition, they will also have specific types of exercise recommended to them. Participants' treating physicians and coaches will be informed about their choices, and will receive supporting medication adjustment documents, based on those made in previous studies. It will remain the responsibility of the treating physicians to adjust any medications the participants are receiving.
The control group is required to meet the same criteria as the intervention group. The control group only receives health assessments (with the exception of the diabetyping), and will not receive any health intervention. They will continue to receive standard diabetes care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This a randomized intervention study. Subjects will be randomly allocated using a 5:1 ratio between the control and intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Active lifestyle intervention | Experimental | Behavioral: Lifestyle interventionIndividuals in the active intervention group will undergo diabetyping (diabetes type 2 phenotyping: glucose, and C-peptide responses to a glucose challenge). Based on the diabetype, individuals will receive recommendations to follow either a calorie-restricted (500kcal deficit minimum) low carbohydrate or a modified Mediterranean diet for a period of 18 weeks (total intervention is 24 weeks). Secondly, individuals will follow a personalized exercise program. Guidance and coaching (individual and small group) will be given via mobile app and digital platform. Individuals will receive real-time feedback based on their diet, exercise, and glucose levels (via continuous glucose monitoring for 4 weeks). Medications will be slowly withdrawn over the intervention period, with a focus on the first phase of the intervention. |
| Usual care group | No intervention | –Individuals in the usual care group will receive standard diabetes care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes: Diagnosis of T2DM without physician defined end-organ failure
- BMI: 25 to 45 kg/m²
- Age: 18 to 75 years
- Most recent HbA1c value should be greater than 6.0% (>43 mmol/mol); if less than 6.5% (<48 mmol/mol), individuals should still be receiving anti-diabetic medication
- Tech-savvy (patients are required to be able to fully use smartphone or tablet)
Key exclusion criteria (30 listed)
- Weight loss of more than five kg or greater than 10% within the past six months
- Serious co-morbidities, for example, a severe form of chronic obstructive pulmonary disease (Gold III or IV), bariatric surgery, heart failure (classes 2-4) kidney failure, or another medically determined end-stage organ failure
- Substance abuse
- Learning difficulties limiting the participation in a digital health intervention and or limiting the comprehension of trial goals or coaching curriculum.
- Current treatment with anti-obesity drugs
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 |
|---|---|---|
| Lifestyle interventionLifestyle coaching will be given on a digital app-based platform. Individuals will receive real-time feedback via a smart scale, activity monitor, and continuous glucose monitor (first 4 weeks, longer if required). Coaching will be focused on gradual behavior change, assisted by digital nudges, one-on-one, and small group coaching sessions. Coaching will include education regarding lifestyle to improve health literacy with respect to diet and diabetes management. Additionally, coaches will guide participants in the implementation of individualized diet and exercise program with varying levels of carbohydrate restriction and caloric deficit. | Behavioural | Active lifestyle intervention |
Primary outcome
Rate of diabetes remission
Time frame: 1 year
Percentage of patients achieving complete diabetes remission. Diabetes remission rates amongst the active intervention group will be reported as the number of participants who have achieved fasting glucose < 7 mmol/L or HbA1c < 6.5% (48 mmol/mol) on two separate occasions 6 months apart, and glucose-lowering therapy has been stopped.
7 secondary outcomes
Rates of improved glycaemic control
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Blood lipids
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Weight loss
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Remission versus diabetype
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Cost effectiveness
Time frame: Will be reported at all follow-up moments (6 months, 1 year, and 2 years)
Digital engagement as measured by the Engagement Index
Time frame: Up to 1 year
Compliance
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Yes. The data will be made available to researchers upon motivated request. Moreover, all supporting documents will be submitted upon publication of the study protocol and results.
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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.
Sarah Mount, PhD contact
Suzan Wopereis, PhD principal investigator
TNO
Maarten van Aken, MD PhD principal investigator
Haga Ziekenhuis
Elly Vogelzang, MD principal investigator
Center Medische Kwartier Eindhoven
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Diabetes Mellitus, Type 2, run by Ancora Health B.V. at 4 sites in Netherlands.
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 6 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Castela Forte, MSc. (+316 28218360, Jose@Ancora.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of diabetes remission (time frame: 1 year). 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 20 Jul 2022.