Phase 1. The primary objective is to asses the usability of the Diameter in secondary care to solve main user problems before the start of the second phase. Phase 2. The primary objective is to assess intervention usage and acceptability of the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters concern insight into the usability (phase 1),
intervention usage (phase 2) and acceptability (phase 2) of the Diameter.
Secondary outcome
In phase 2, secondary objectives are to explore behavioural (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).
Background 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 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 behaviour change may improve patients*
diabetes management.
Based on this, we hypothesize that a technology-enabled lifestyle intervention
is effective and a step forward in DMT2 management. In the Twente region, we
are developing a personalized treatment strategy to improve the lifestyle of
DMT2 patients by providing coaching and feedback in daily life via a mobile
application, the Diameter. The development of the Diameter is a collaboration
between Ziekenhuisgroep Twente (ZGT) and University of Twente (UT), and will be
provided via the Ancora Health platform. The Diameter provides the ability to
monitor food intake, physical activity and glucose levels; it provides
individual patients and healthcare professionals with insight into lifestyle,
blood glucose levels and the effect of lifestyle behavior on glucose levels in
daily life. In addition, the Diameter offers evidence-based coaching, developed
in collaboration with the Netherlands Organization for Applied Scientific
Research (TNO), aimed at improving lifestyle in the areas of physical activity
and nutrition.
Study objective
Phase 1. The primary objective is to asses the usability of the Diameter in
secondary care to solve main user problems before the start of the second
phase.
Phase 2. The primary objective is to assess intervention usage and
acceptability of the Diameter as blended-care intervention in primary and
secondary care. Secondary objectives are to explore behavioural (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).
Study design
Phase 1. A mixed-methods cross-sectional study will be performed. Patients will
use the Diameter for 5 weeks and afterwards a semi-structured interview about
the usability of the Diameter and think-aloud test about a non-validated
questionnaire will be performed.
Phase 2.This study has a mixed-method design with 3 (regular participants ZGT
and primary care) 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 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.
Intervention
Regular treatment in primary or secondary care or during COOL will be
complemented with the Diameter: a mobile application which 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 sensor). The Diameter also provides autonomous lifestyle
coaching via daily coaching messages, short weekly e-mails and exercises aimed
at goal achievement.
Study burden and risks
Extra visits to the outpatient clinic or general practitioner (GP) are kept to
a minimum, as data (excl. questionnaires) will be collected as much as possible
during regular hospital/GP visits. For phase 2, extra physiological
non-invasive measurements include body impedance and handgrip strength test.
The total expected time burden for patients is 120, 420 and 105 minutes for the
three phases respectively. In phase 1 and 2, participants are required to wear
the Fitbit and Freestyle Libre.
Zilvermeeuw 1
Almelo 7609 PP
NL
Zilvermeeuw 1
Almelo 7609 PP
NL
Listed location countries
Age
Inclusion criteria
• Being diagnosed with type 2 diabetes;
• Being treated in the outpatient clinic at ZGT or in primary care;
• Being familiar with using a smartphone.
Exclusion criteria
• Dependence on renal replacement therapy;
• Severe general diseases or mental disorders making participation in the study
impossible;
• Insufficient mastery of the Dutch language;
• Other CGM device than Freestyle Libre.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05307120 |
| CCMO | NL75953.100.20 |