Lifestyle Monitoring and Coaching Using the Mobile DIAMETER Application in Secondary Care

NCT05307120 | Recruiting DMC

• 1 other identifier: NL75953.100.20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Intervention usage - frequency

  The way in which the intervention is actually used in terms of frequency (number of time used over time)

  T1 (week 13-14)

• Intervention usage - duration

  The way in which the intervention is actually used in terms of duration (minutes of use over time)

  T1 (week 13-14)

• Acceptability

  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.

  T1 (week 13-14)

Secondary Outcomes (31)

• Glucose-lowering medication usage

  T0 (baseline), T1 (week 13-14), T2 (week 25-26)

• T2DM-related medication usage

  T0 (baseline), T1 (week 13-14), T2 (week 25-26)

• Glycemic regulation - eHbA1c

  T0 (baseline), T1 (week 13-14), T2 (week 25-26)

• Glycemic regulation - Time In Range (TIR)

  T0 (baseline), T1 (week 13-14), T2 (week 25-26)

• Glycemic regulation - Time Below Range (TBR)

  T0 (baseline), T1 (week 13-14), T2 (week 25-26)

Other Outcomes (8)

• Age

  T0 (baseline)

• Gender

  T0 (baseline)

• Duration of type 2 diabetes diagnosis

  T0 (baseline)

Study Arms (1)

Intervention

EXPERIMENTAL

Regular T2DM treatment in secondary care will be complemented with the Diameter: a mobile application on 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

Interventions

Diameter integrated in secondary diabetes care DEVICE

Regular T2DM treatment in secondary care will be complemented with the Diameter: a mobile application on 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus
• Being familiar with using a smartphone
• Being treated in ZGT hospital or primary care

You may not qualify if:

• Dependence on renal replacement therapy
• Severe general diseases or mental disorders make the participation in the study impossible
• Insufficient mastery of the Dutch language
• Other CGM device than Freestyle Libre.

Sponsors & Collaborators

• University of Twente: lead
• Ziekenhuisgroep Twente: collaborator

Study Sites (1)

Ziekenhuisgroep Twente (Hospital Group Twente; ZGT)

Almelo, Overijssel, 7600 SZ, Netherlands

RECRUITING

Related Publications (15)

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  PMID: 29617337 BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 12939124 BACKGROUND

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  PMID: 21479777 BACKGROUND

• Rogers, E., Diffusion of Innovations Fifth edition Free Press. 2003, New York Pp107, pp111, pp127.

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  PMID: 21951248 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eclaire Hietbrink, MSc.

  University of Twente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eclaire Hietbrink, MSc.

CONTACT

+31534895398; e.a.g.hietbrink@utwente.nl

Goos Laverman, Prof. dr.

CONTACT

g.laverman@zgt.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective single-arm longitudinal mixed-methods design

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 1, 2022
• Study Start: January 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)