Clinical trial NCT06134934: TeleCare North Diabetes
Official title: TeleCare North Diabetes: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Blood glucose
Diabetes mellitus
Type 2
Telemedicine
Telehealth
Telemonitoring
Feasibility
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Nordjylland
name: Aalborg University
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This feasibility study will evaluate the feasibility of two telemonitoring designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.

Detailed description: Background: Maintaining optimal glycaemic control in type 2 diabetes (T2D) is difficult. Telemedicine has potential to support poorly controlled people with T2D in the achievement of glycaemic control if the telemedicine solution includes a telemonitoring component. However, only few telemonitoring solutions for non-insulin treated T2D exist. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring intervention designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.

Method: The trial will be conducted as a three-month randomized feasibility study in four municipalities in North Denmark with 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, differences in direct intervention costs between the two alternative interventions will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Women and men ≥ 18 years
* Poorly controlled T2D, i.e. HbA1c \> 58 mmol/mol
* Diagnosis of T2D for at least 12 months
* General Practitioner responsible for diabetes treatment
* Residence in Hjørring, Morsø, Jammerbugt, or Rebild municipality
* Ability and willingness to use a smartphone/tablet along with the other devices to be used in the trial
* Signed informed consent
* Ability to understand and read Danish

Exclusion Criteria:

* Pregnancy or breastfeeding
* Insulin treatment
* Prednisolone treatment
* Severe diabetes complications such as severe neuropathy or nephropathy (dialysis treatment)
* Participation in diabetes rehabilitation courses
* Participation in other intervention trials
* Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate

Primary outcomes:
measure: Experiences with and acceptability of intervention design(s)
timeFrame: 3 months
Secondary outcomes:
measure: Feasibility of the recruitment assessment 1
timeFrame: 1 month
measure: Feasibility of the recruitment assessment 2
timeFrame: 1 month
measure: Feasibility of the recruitment assessment 3
timeFrame: 1 month
measure: Feasibility of the recruitment assessment 4
timeFrame: 1 month
measure: Feasibility of the recruitment assessment 5
timeFrame: 1 month
measure: Retention assessment 1
timeFrame: 3 months
measure: Retention assessment 2
timeFrame: 3 months
measure: Retention assessment 3
timeFrame: 3 months
measure: Retention assessment 4
timeFrame: 3 months
measure: Retention assessment 5
timeFrame: 3 months
measure: Adherence to answering the questionnaire: Diabetes-related quality of life: The Problem Areas in Diabetes Questionnaire (PAID-5)
timeFrame: At baseline (T0) and 3 months (T1)
measure: Adherence to answering the questionnaire: Quality of Life: The Short Form 12 Questionnaire (SF-12v2)
timeFrame: At baseline (T0) and 3 months (T1)
measure: Adherence to answering the questionnaire: Well-being: The World Health Organization Five Well-being Index (WHO-5)
timeFrame: At baseline (T0) and 3 months (T1)
measure: Adherence to answering the questionnaire: The Patient Activation Measure questionnaire (PAM)
timeFrame: At baseline (T0) and 3 months (T1)
measure: Challenges in the blood sampling schedule
timeFrame: At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3)
measure: Adherence to the blood sampling schedule
timeFrame: At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3)
measure: Costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Steno Diabetes Center North Denmark
Study officials:
affiliation: Aalborg University Hospital and Steno Diabetes Center North Denmark
name: Peter Vestergaard, PhD (and MD)
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University and Aalborg University Hospital
name: Sisse H Laursen, PhD
role: STUDY_CHAIR
affiliation: Aalborg University and Steno Diabetes Center North Denmark
name: Stine Hangaard, PhD
role: STUDY_CHAIR
References: