TeleCare North Diabetes

Aalborg University Hospital

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Telemonitoring 2; Other: Telemonitoring 1

Study type: Interventional

Funder types: Other

Identifiers

NCT06134934

N-20230026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Telemonitoring design 1

Experimental group

Description:

* Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health * Blood pressure * Activity

Treatment:

Other: Telemonitoring 1

Telemonitoring design 2

Experimental group

Description:

* Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health

Treatment:

Other: Telemonitoring 2