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Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission (IBIDEM)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Not yet recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Lifestyle intervention

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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)

Sites / Locations

St. Anna Ziekenhuis
Center Medische Kwartier Eindhoven
Huisartsenpraktijk Zonneoord
Haga Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active lifestyle intervention

Usual care group

Arm Description

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.

Individuals in the usual care group will receive standard diabetes care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Blood lipids

Changes in blood lipids, namely triglycerides, total cholesterol, LDL, and HDL will be measured as an indicator of health status

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05346614

First Posted

February 3, 2022

Last Updated

July 19, 2022

Sponsor

Ancora Health B.V.

Collaborators

University of Groningen, Universiteit Leiden, TNO

1. Study Identification

Unique Protocol Identification Number

NCT05346614

Brief Title

Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission

Acronym

IBIDEM

Official Title

Digital, Blended Lifestyle Intervention Program for Remission and Improved Management of Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2022 (Anticipated)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ancora Health B.V.

Collaborators

University of Groningen, Universiteit Leiden, TNO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This a randomized intervention study. Subjects will be randomly allocated using a 5:1 ratio between the control and intervention groups.

Masking

Outcomes Assessor

Masking Description

Outcome assessors will be blinded to the treatment allocations. It is not possible to blind participants or care providers who will be providing the intervention, as this is a lifestyle intervention. Controls receive usual care.

Allocation

Randomized

Enrollment

410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active lifestyle intervention

Arm Type

Experimental

Arm Description

Arm Title

Usual care group

Arm Type

No Intervention

Arm Description

Individuals in the usual care group will receive standard diabetes care.

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of diabetes remission

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Rates of improved glycaemic control

Description

Time Frame

Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

Title

Blood lipids

Description

Changes in blood lipids, namely triglycerides, total cholesterol, LDL, and HDL will be measured as an indicator of health status

Time Frame

Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

Title

Weight loss

Description

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.

Time Frame

Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

Title

Remission versus diabetype

Description

Time Frame

Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

Title

Cost effectiveness

Description

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.

Time Frame

Will be reported at all follow-up moments (6 months, 1 year, and 2 years)

Title

Digital engagement as measured by the Engagement Index

Description

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.

Time Frame

Up to 1 year

Title

Compliance

Description

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

José Castela Forte, MSc.

Phone

+316 28218360

Jose@Ancora.health

First Name & Middle Initial & Last Name or Official Title & Degree

Sarah Mount, PhD

Sarah@Ancora.health

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzan Wopereis, PhD

Organizational Affiliation

TNO

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maarten van Aken, MD PhD

Organizational Affiliation

Haga Ziekenhuis

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Elly Vogelzang, MD

Organizational Affiliation

Center Medische Kwartier Eindhoven

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Janet Kist, MD

Organizational Affiliation

Huisartsenpraktijk Zonneoord

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jan Hoogsteen, MD

Organizational Affiliation

Ancora Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rimke Vos, PhD

Organizational Affiliation

Department of Public Health and Primary Care / LUMC-Campus Den Haag

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Anna Ziekenhuis

City

Eindhoven

State/Province

Limburg

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arno Toorians, MD

Phone

+31 40 286 4040

a.toorians@st-anna.nl

Facility Name

Center Medische Kwartier Eindhoven

City

Eindhoven

State/Province

Noord Brabant

ZIP/Postal Code

5611 NV

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elly Vogelzang, MD

Phone

+31040 211 51 79

e.vogelzang@medischkwartiereindhoven.nl

Facility Name

Huisartsenpraktijk Zonneoord

City

Den Haag

State/Province

Zuid Holland

ZIP/Postal Code

2544 KM

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janet Kist, MD

Phone

+31070 321 4567

j.m.kist@lumc.nl

Facility Name

Haga Ziekenhuis

City

Den Haag

State/Province

Zuid Holland

ZIP/Postal Code

2545 AA

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maarten van Aken, PhD, MD

Phone

+31070 210 0000

m.vanaken@hagaziekenhuis.nl

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Undecided.

IPD Sharing Access Criteria

Undecided.

Learn more about this trial

Digital, Blended Lifestyle Intervention for Type 2 Diabetes Remission

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