Telemonitoring for managing Type 2 diabetes
TeleCare North Diabetes: a Feasibility Study
NA · Aalborg University Hospital · NCT06134934
This study is testing two different telemonitoring methods to see if they can help people with Type 2 diabetes who don't use insulin better manage their blood sugar levels.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital (other) |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT06134934 on ClinicalTrials.gov |
What this trial studies
This feasibility study evaluates two telemonitoring designs aimed at improving glycaemic control in non-insulin treated patients with Type 2 diabetes (T2D). Conducted over three months in four municipalities in North Denmark, the study will involve 60 participants who will be randomly assigned to one of two intervention groups. One group will focus on self-monitoring of blood glucose along with sleep and mental health monitoring, while the other will add blood pressure and activity monitoring. Qualitative interviews will be conducted to gather insights on participant and clinician experiences with the interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with poorly controlled Type 2 diabetes who are not on insulin treatment.
Not a fit: Patients who are pregnant, breastfeeding, or have severe diabetes complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of Type 2 diabetes through effective telemonitoring solutions.
How similar studies have performed: Other studies have shown promise in using telemedicine for diabetes management, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg
- Steno Diabetes Center North Denmark — Aalborg, Denmark (RECRUITING)
Study contacts
- Principal investigator: Peter Vestergaard, PhD (and MD) — Aalborg University Hospital and Steno Diabetes Center North Denmark
- Study coordinator: Sisse H Laursen, PhD
- Email: sih@hst.aau.dk
- Phone: +4528189779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Blood glucose, Diabetes mellitus, Type 2, Telemedicine, Telehealth, Telemonitoring, Feasibility