Actively Recruiting
Led by Aalborg University Hospital · Updated on 2026-02-09
51
Participants Needed
1
Research Sites
N/A
Total Duration
A
Aalborg University Hospital
Lead Sponsor
N
Novo Nordisk A/S
Collaborating Sponsor
Researchers are evaluating telemonitoring methods to support insulin treatment in adults with type 2 diabetes (T2D) who are on insulin therapy. This open-label, randomized controlled trial compares an intelligent telemonitoring system that uses decision-support algorithms with regular telemonitoring and usual care. The study aims to understand how these technologies affect glucose control and treatment management over a three-month period. Participants will be randomly assigned to one of three groups: the intelligent telemonitoring group, the telemonitoring group, or the usual care group. Both telemonitoring groups will use devices including a continuous glucose monitor (CGM), an insulin pen, an activity tracker (Fitbit), and a smartphone application during the trial. The intelligent telemonitoring group additionally benefits from decision-support algorithms accessible to both hospital staff and patients, including a risk assessment tool for nocturnal hypoglycemia. Hospital staff will monitor data and contact participants by telephone as needed. The usual care group will use blinded devices and will not have their data monitored during the trial. Participants will attend in-person visits at the trial site and have their glucose and insulin data closely monitored by hospital staff throughout the three-month trial. Assessments include continuous glucose monitoring metrics such as time in range, hypoglycemia and hyperglycemia episodes, HbA1c levels, insulin use, weight, quality of life measures, and treatment satisfaction. Researchers will track device usage and treatment adherence, while safety and overall health will be monitored during the study period ending in September 2026.
CONDITIONS
The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants will be assigned to one of three groups: intelligent telemonitoring, telemonitoring alone, or usual care. Those in the telemonitoring groups will use a continuous glucose monitor (CGM), insulin pen, activity tracker, and smartphone application throughout the three-month trial period. Hospital staff will monitor data and contact participants by telephone as needed. Participants in the intelligent telemonitoring group will receive additional decision support and risk assessments through a smartphone app. Participants in the usual care group will use blinded CGM and insulin pen devices without monitoring.
Regular telephone contacts and in-person visits as needed
Total: 1 location
1
Department of Endocrinology
Aalborg, North Jutland, Denmark, 9000
Actively Recruiting
J
Jannie Nørlev, PhD
S
Stine Hangaard, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Camilla H N Thomsen, Jannie T D Nørlev, Stine Hangaard...
https://pubmed.ncbi.nlm.nih.gov/39511648