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Lifestyle Monitoring and Coaching Using the Mobile DIAMETER Application in Secondary Care (DIAMETER-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05307120
Recruitment Status : Recruiting
First Posted : April 1, 2022
Last Update Posted : May 10, 2023
Sponsor:
Collaborator:
Ziekenhuisgroep Twente
Information provided by (Responsible Party):
Eclaire Hietbrink, University of Twente

Brief Summary:

Type 2 Diabetes Mellitus (T2DM) is a major chronic lifestyle-related disorder with a significant impact on quality and costs of care. As patients with T2DM often have insufficient knowledge about proper self-management and are insufficiently motivated for a lifestyle change, interventions with more motivational strategies and personalization are needed. The use of real-time monitoring of glucose values, nutrition and physical activity in combination with coaching aimed at lifestyle-related behavior change may improve patients' diabetes management. Therefore, ZGT, UT and RRD developed the Diameter app. The aim of phase 2 of this study is to investigate the Diameter as blended-care using a feasibility study. The primary objective of this feasibility study is to assess intervention usage and acceptability of the Diameter as a blended-care intervention in secondary care, of which some are also following a combined lifestyle intervention (GLI). Secondary objectives are to explore behavioral (e.g. physical activity), physiological (e.g. BMI), psychological (e.g. health-related quality of life) and clinical outcomes (e.g. glucose control, estimated HbA1c values).

This study has a mixed-method design with 3 (regular participants) or 4 (participants who decide to follow the Combined Lifestyle Intervention (GLI) COOL next to the Diameter during the study period) data collection points.

Patients will start with a two-week period of baseline measurements. Subsequently, patients will use the Diameter as a blended-care intervention for 10 weeks. The two-week measurement periods will be repeated twice (T1: week 13-14 and at T2: week 25-26). Between T1 and T2, patients will use a version of the Diameter without daily coaching messages. At T1 and T2, questionnaires will be administered, data on physical activity, food intake and glucose values will be logged, and blood and urine samples will be retrieved from regular care measurements. In addition, open-ended interviews will be performed with 10-15 patients at T1. For participants who also decided to follow the COOL program, some routinely collected measurements as part of the COOL program will be obtained from the patient record.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: Diameter integrated in secondary diabetes care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A prospective single-arm longitudinal mixed-methods design
Masking: None (Open Label)
Masking Description: The primary study aim is to assess intervention usage and acceptability (e.g. effort expectancy, pleasure) regarding the Diameter integrated in regular secondary care and how acceptability is associated with intervention usage. Therefore, the study does not make use of a double blind randomized controlled trial as this design does not fit the study's primary purpose. Consequently, there will be no randomization and treatment allocation. To minimize the treatment effect at baseline, baseline measures will be blinded as much as possible, i.e., participants will not be able to get insight in their glucose values and nutrient intake. The physical activity data collected with the Fitbit cannot be blinded, so that the participants do have insight into their physical activity during the baseline measurements
Primary Purpose: Treatment
Official Title: Lifestyle Monitoring and Coaching Using the Mobile DIAMETER Application in Secondary Care (DIAMETER-1, Phase 2 - Feasibility Study).
Actual Study Start Date : January 13, 2022
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Arm Intervention/treatment
Experimental: Intervention
Regular T2DM treatment in secondary care will be complemented with the Diameter: a mobile application on Android smartphones that enables continuous monitoring of nutrition (via food diary), physical activity (via activity tracker Fitbit and self-reported activities) and blood glucose values (via Freestyle libre 2 sensors). The Diameter also provides autonomous lifestyle coaching via daily coaching messages, short weekly e-mails and exercises aimed at goal achievement.
Device: Diameter integrated in secondary diabetes care
Regular T2DM treatment in secondary care will be complemented with the Diameter: a mobile application on Android smartphones that enables continuous monitoring of physical activity (via activity tracker Fitbit and self-reported activities) and nutrition (via food diary) and blood glucose values (via Freestyle Libre sensor). The Diameter also provides autonomous lifestyle coaching via daily coaching messages, short weekly e-mails and exercises aimed at goal achievement.




Primary Outcome Measures :
  1. Intervention usage - frequency [ Time Frame: T1 (week 13-14) ]
    The way in which the intervention is actually used in terms of frequency (number of time used over time)

  2. Intervention usage - duration [ Time Frame: T1 (week 13-14) ]
    The way in which the intervention is actually used in terms of duration (minutes of use over time)

  3. Acceptability [ Time Frame: T1 (week 13-14) ]

    Acceptability will be assessed using an UTAUT2 questionnaire of 19 questions. The UTAUT2 determinants include performance expectancy, effort expectancy, pleasure/hedonic motivation, facilitating circumstances, design, technical issues and habit. The experiences with the Diameter will be assessed using multiple statements generated by the research team according to literature and previous used UTAUT2-model based questionnaires. Each statement will be scored on a 7-point Likert scale (1 = extremely disagree, 7 = extremely agree) where a higher score indicate positive experiences with the Diameter. The scores will be used to calculate individual sum scores per determinant of the UTAUT2 model.

    Open-ended interviews will be conducted with a subset of 10-15 participation to gain in-depth information on the acceptability, and perceived barriers and facilitating conditions for usage of the Diameter.



Secondary Outcome Measures :
  1. Glucose-lowering medication usage [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    The amount of glucose-lowering medication usage will be assessed via electronic health record data and printed prescriptions from the pharmacy, checked with the patient.

  2. T2DM-related medication usage [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    The total number of T2D- related medication, includes glucose-lowering medication, medication for blood pressure and medication for cholesterol, will be assessed via electronic health record data and printed prescriptions from the pharmacy, checked with the patient.

  3. Glycemic regulation - eHbA1c [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Estimated HbA1c (eHbA1c) will be calculated from glucose measurements assessed with the Freestyle Libre using accepted algorithms. The eHbA1c decreases with a least 10% for patients who are above target value of 53 mmol/mol, independent from the treatment schedule, and no clinically relevant increase in blood glucose lowering medication dose.

  4. Glycemic regulation - Time In Range (TIR) [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Time In Range (TIR) is a new parameter to evaluate blood glucose control. The TIR represents the total time per day that the glucose value is between 3.9 and 10.0 mmol/L. The higher the TIR, the better the diabetes is managed during the day. Algorithms will be used to calculate the TIR based on the glucose values assessed with the Freestyle Libre.

  5. Glycemic regulation - Time Below Range (TBR) [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Time Below Range (TBR) represents the total time per day that the glucose value is below 3.9 mmol/L. The TBR will be calculated with algorithms based on the glucose values assessed with the Freestyle Libre.

  6. Glycemic regulation - Time Above Range (TAR) [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Time Above Range (TAR) represents the total time per day that the glucose value is above 10 mmol/L. The TAR will be calculated with algorithms based on the glucose values assessed with the Freestyle Libre.

  7. Body composition [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]

    Body composition (impedance) measuring of the fat, muscle and water percentage which will be determined by 2 non-invasive devices: Bodyscan® Quadstad 4000 and TANITA® BC418MA.

    Body Mass Index (BMI, (kg/m2)) will be calculated using the measurement of weight and height collected in the outpatient clinic.

    Waist and hip circumference will be determined with a tape measure to assess the distance around the smallest part of the waist and the distance around the largest part of the hips.


  8. Body Mass Index [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Body Mass Index (BMI, (kg/m2)) will be calculated using the measurement of weight and height collected in the outpatient clinic.

  9. Waist and hip circumference [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Waist and hip circumference will be determined with a tape measure to assess the distance around the smallest part of the waist and the distance around the largest part of the hips.

  10. HbA1c [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    HbA1c (mmol/mol) will be obtained from the blood samples that are taken as part of regular care from the patient record.

  11. Fasting glucose [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Fasting glucose (mg/dL) will be obtained from the blood samples that are taken as part of regular care from the patient record.

  12. Total cholesterol [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Total cholesterol (mmol/L) will be obtained from the blood samples that are taken as part of regular care from the patient record.

  13. HDL-cholesterol [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    HDL-cholesterol (mmol/L) will be obtained from the blood samples that are taken as part of regular care from the patient record.

  14. LDL-cholesterol [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    LDL-cholesterol (mmol/L) will be obtained from the blood samples that are taken as part of regular care from the patient record.

  15. Triglycerides [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Triglycerides (mmol/L) will be obtained from the blood samples that are taken as part of regular care from the patient record.

  16. eGFR [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    eGRF (ml/min/1,73 m2) will be obtained from the blood samples that are taken as part of regular care from the patient record.

  17. Creatinine [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Creatinine (mmol/L) will be obtained from morning void urine as part of regular care, which will be sent to the laboratory for analysis and storage. Morning void data will be derived from the patient record and used for analysis.

  18. Albumin [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Albumin (mg/L) will be obtained from morning void urine as part of regular care, which will be sent to the laboratory for analysis and storage. Morning void data will be derived from the patient record and used for analysis.

  19. Albumin/creat ratio [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Albumin/creat ratio (g/mol kr) will be obtained from morning void urine as part of regular care, which will be sent to the laboratory for analysis and storage. Morning void data will be derived from the patient record and used for analysis.

  20. Blood pressure [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Blood pressure will be measured as part of regular care three times automatically every minute for 15 minutes in a supine position through the Dinamap®.

  21. Peripheral neuropathy [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Peripheral neuropathy will be evaluated with the touch test as part of regular care. This test is performed by pricking the monofilament under the big, middle and small toes of both feet. If the patient does not feel 2 or more of these pricks, this is diagnosed as having peripheral neuropathy.

  22. Handgrip strength [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Handgrip strength will be determined with a hand grip strength test which is an extra measurement compared to regular care.

  23. Amputations [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    The presence of toe/foot/leg amputations will be queried during the anamnesis. Specifically, participants will be asked about the year of amputation(s), on which side and at what level (from DIP joint to hip joint) the amputation took place.

  24. Ulcers [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    The presence of ulcers will be queried during the anamnesis and assessed during the physical examination. The participant will be asked about the time of onset, the side, location and the current treatment of the ulcer. During the physical examination, the ulcer will be classified based on the Texas classification (depth 0-3, infection/ischemia A-D).

  25. Physical activity [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Physical activity will be assessed using the Fitbit or using the manually entered log-data in the Diameter. Steps per minute assessed with de Fitbit will be used provide information on levels of physical activity. In addition, these data can be used toe calculate other activity parameters (e.g., moderate to vigorous physical activity bouts, sedentary behavior, step cadence and peak activity index). To this purpose, scripts in Matlab have previously been developed and tested extensively. Steps per minute and total minutes of moderate to vigorous per week will be used to analyse the intervention effects.

  26. Nutritional behavior [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Nutritional behavior will be assessed using the food diary in the Diameter. The Diameter logs (number of days logged, and mean number of logs per day), the eaten products at that time and nutritional components (carbohydrates, fat, protein, sugar and kilocalories). To assess the intervention effects, the mean number of carbohydrates, fat, protein, sugar and kilocalories per day will be used. Participants are asked to fill in the food diary for 6 days fper measurement moment, as 6 days are required to be able to measure variety in carbohydrabe intake. It is expected that filling in the food diary will take 10 minutes per day. This will take participants approximately a total of 60 minutes spread over 6 days per measurement moment (T0, T1 and T2), which makes a total of 180 minutes.

  27. Treatment adherence [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Treatment adherence will be assessed using de Beliefs about Medicines Questionnaire (BMQ). The BMQ consists of 19 items and comprises 2 sections: the BMQ-Specific which assesses representations of medication prescribed for personal use. The score for each subscale is between 5 and 20. A low score on necessity means a low confidence in the necessity of the prescribed medication, a high score indicates the opposite. A low score on the concerns (concern) means a high confidence in the positive effects of the prescribed medication. A high score means the opposite. The BMQ-General which assesses beliefs about medicines in general. The score for each subscale is between 4 and 20. A low score on the negative consequences (harm) indicates a great confidence in the positive consequences of the use of medication in general. A high score means low confidence in the positive consequences of the use of medication.

  28. Self-efficacy [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Self-efficacy will be assessed with all 20 items of the Diabetes Management Self-Efficacy scale for patients with T2DM (DMSES) using a 5-point Likert scale (1 probably not - 5 definitely yes). The scale was developed based on the self-care activities these patients have to carry out in order to manage their diabetes. The scale focuses on nutrition specific and weight, nutrition general and medical treatment, physical exercise and blood sugar. The 2 questions about the use of oral medication will be made optional as these questions do not apply for patients who have a treatment schedule that includes insulin. A sum score wil be calculated summing all items (range 20-100).

  29. Self-management [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Self-management using the Patient Activation Measure (PAM) a 100-point quantifiable scale determining patient engagement in healthcare. It is a 13-item instrument which assesses patient (or consumer) self-reported knowledge, skills and confidence for self-management of one's health or chronic condition. Based on the PAM score patients can be classified into 4 categories ranging from more passive patients who perceived to have minimal control (1) to having perceived to being absolutely capable of managing their disease (PAM 4).

  30. Stages of change [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Stages of change using the single item questionnaire Self-Assessment Scales (SAS) Stages of Change. It assess a person's adherence to lifestyle guidelines using 5-point Likert scale. The stage of change is assessed with the following single question: Are you physically active for more than 30 minutes a day / consciously engaged in a healthy diet at least 5 days a week? The 5 answer options are traceable to the 5 stages of change of the Transtheoretical Model, i.e., precontemplation, contemplation, preparation, action and maintenance.

  31. Health-related quality of life [ Time Frame: T0 (baseline), T1 (week 13-14), T2 (week 25-26) ]
    Health-related quality of life using the EQ-5D-5L. The EQ-5D-5L is a generic instrument for describing and valuing health. It defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/comfort, and anxiety/depression. Each dimension has 5 response categories ranging from no problems (1) to extreme problems (5). Also the VAS is included in this questionnaire. The EQ-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.


Other Outcome Measures:
  1. Age [ Time Frame: T0 (baseline) ]
    Age (year) will be collected during the visit to the outpatient clinic.

  2. Gender [ Time Frame: T0 (baseline) ]
    Gender (m/v/other) will be collected during the visit to the outpatient clinic.

  3. Duration of type 2 diabetes diagnosis [ Time Frame: T0 (baseline) ]
    Duration of type 2 diabetes diagnosis (years) will be collected during the visit to the outpatient clinic.

  4. Educational background [ Time Frame: T0 (baseline) ]
    Educational background (no education, primary education, lower secondary education, upper secondary education, bachelor, masters) will be collected during the visit to the outpatient clinic.

  5. Migration background [ Time Frame: T0 (baseline) ]
    Migration background will be collected during the visit to the outpatient clinic. The migration background is asked because T2DM is relatively more common among certain cultures than among others. After the study, the question about migration background will be used to assess whether the different cultures are sufficiently represented by the participants in this study. If participants do not want to answer this question, they have the option to choose "I don't want to say this".

  6. Medical history [ Time Frame: T0 (baseline) ]
    Medical history will be collected from the electronic patient files. Medical history of interest are past potential diabetic related complications such as: coronary disease, myocardial infarction, cardiac catheterization, stroke or heart bypass.

  7. Openness to the use of new technologies [ Time Frame: T0 (baseline) ]
    Openness to the use of new technologies measured with single-question based on the innovation theory by Rogers. This question enables to characterize people regarding 5 domains: innovators, early adopters, early majority, late majority and laggards.

  8. Health literacy [ Time Frame: T0 (baseline) ]
    Health literacy will be assessed using the Set of Brief Screening Questions (SBSQ). The SBSQ is validated in Dutch and contains three questions with a 5-point Likert scale (0 never/ very sure - 4 always/not at all sure) as answer options. The higher the score, the better the literacy. Low literacy is defined as a mean score of 2 or less.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with type 2 diabetes and being treated in the outpatient clinic at ZGT;
  • Being familiar with using an Android smartphone (version 8.0 or higher);
  • Aged 18 years or older;
  • Competent: person can understand and weigh up information provided by researcher and can understand what the concequences of participation are.
  • Provide written informed consent.

Exclusion Criteria:

  • Dependence on renal replacement therapy;
  • Severe general diseases or mental disorders making the participation in the study impossible;
  • Drug abuse
  • Insufficient mastery of the Dutch language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05307120


Contacts
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Contact: Eclaire Hietbrink, MSc. +31534895398 e.a.g.hietbrink@utwente.nl
Contact: Annemieke Konijnendijk, Dr. +31534893231 a.a.j.konijnendijk@utwente.nl

Locations
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Netherlands
Ziekenhuisgroep Twente (Hospital Group Twente; ZGT) Recruiting
Almelo, Overijssel, Netherlands, 7600 SZ
Contact: Eclaire Hietbrink, MSc.    +31534895398    e.hietbrink@zgt.nl   
Contact: Goos Laverman, Prof.dr.    +31887083079    g.laverman@zgt.nl   
Sponsors and Collaborators
University of Twente
Ziekenhuisgroep Twente
Investigators
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Principal Investigator: Eclaire Hietbrink, MSc. University of Twente
Publications:
Glanz, K., B.K. Rimer, and K. VIswanath, Health behavior and health education: Theory, research, and practice, 4th ed. Health behavior and health education: Theory, research, and practice, 4th ed., ed. K. Glanz, B.K. Rimer, and K. Viswanath. 2008, San Francisco, CA, US: Jossey-Bass
Gant, C.M., Opportunities for Improvement of Cardiovascular Risk Management in Patients with Type 2 Diabetes and Chronic Kidney Disease: Integrated Assessment of Lifestyle Habits and Pharmacological Intervention in Routine Clinical Care. 2018, Rijksuniversiteit Groningen.
Venkatesh, V., J.Y. Thong, and X. Xu, Consumer acceptance and use of information technology: extending the unified theory of acceptance and use of technology. MIS quarterly, 2012: p. 157-178.
Gill, P.K.S., et al., Handgrip strength in patients with type 2 diabetes mellitus. Pakistan Journal of Physiology, 2016. 12(2): p. 19-21.
Baranowski, T., 24-hour recall and diet record methods. Nutritional epidemiology, 2012. 40: p. 49-69.
Horne, R., J. Weinman, and M. Hankins, The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and health, 1999. 14(1): p. 1-24.
Rogers, E., Diffusion of Innovations Fifth edition Free Press. 2003, New York Pp107, pp111, pp127.

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Responsible Party: Eclaire Hietbrink, Principal Investigator, University of Twente
ClinicalTrials.gov Identifier: NCT05307120    
Other Study ID Numbers: NL75953.100.20
First Posted: April 1, 2022    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases