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An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes.

ConditionDiabetes Type 2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Twente

About this trial

The aim of this study is to evaluate the feasibility and effectiveness of a remote personalised lifestyle program in individuals with T2D. Outcomes will be assessed at the start and after 3, 6, and 12 months with two follow-up measurements (18 and 24 months) to determine whether participation in this re-mote lifestyle program leads to improvements in health and diabetes-related outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 years

HbA1c: ≥53 mmol/mol (7 - 12%)

Signed informed consent form and willing to comply with the study procedures

Persons who are naïve for participation in a lifestyle program for the past two years

Disqualifiers

Medication use: any other glucose-lowering medication than metformin

Comorbidities or medical conditions requiring a special diet that conflicts with the study

Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight)

Circumstances that lead to unreliable HbA1c values, such as blood donation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifestyle program

    Behavioral

    Participants are asked to work on improving their lifestyle. They have access to an online community throughout the study, where they can get in touch with other participants within their research-arm. Participants are also asked to attend twelve online group sessions, during which a lifestyle coach will explain more about nutrition, physical activity, sleep, stress, social aspects, challenges and setbacks, and long-term maintenance.

  • Lifestyle program + coach

    Device

    Idem to arm one, supplemented with a virtual AI lifestyle coach. The AI lifestyle coach can process all the information about the participant that was provided at baseline. This information is compiled into a participant profile, which the AI lifestyle coach uses to initiate personalised conversations with the participant. During these conversations, the AI lifestyle coach supports the participant through a structured coaching cycle of three phases: preparation (reflecting on what matters and co-creating a personalised plan), coaching (day-to-day support to work on the plan), and evaluation (reviewing progress and adjusting or renewing the plan). The coach draws on an evidence-based knowledge base of lifestyle interventions to recommend appropriate, evidence-informed actions. The use of the AI lifestyle coach is an additional topic to the online group sessions.

  • Lifestyle program + coach + CGM

    Device

    Idem to arm two, but participants are also asked to wear an CGM four times for two consecutive weeks. The glucose values information collected by the CGM is used by the AI lifestyle coach to make conversations with the participant even more personalized. The use of CGMs is an additional topic to the online group sessions.

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: Arm 1Active comparator 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c levels

The main study parameter is the impact of the lifestyle program on blood glucose levels, as evaluated by changes in HbA1c levels at the beginning of the study and after 3, 6 and 12 months.

Time frame
From the beginning of the study to the end of the study at 12 months

Secondary outcomes

1

Change in body weight

Time frame
From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
2

Change in blood pressure

Systolic and diastolic blood pressure

Time frame
From the beginning of the study to the end of the study (12 months)
3

Change in medication use

Time frame
From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months
4

Change in waist and hip circumference

Time frame
From the beginning of the study to the end of the study (12 months), including the two follow-up measurements at 18 and 24 months

Other outcomes

1

Socio-demographic characteristics

Socio-demographic characteristics obtained with the baseline questionnaire.

Time frame
At baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Twente

Lead sponsor

TNO

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: