The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
- Conditions
- Type 2 Diabetes Treated with Insulin
- Interventions
- Device: Intelligent telemonitoringDevice: Telemonitoring
- Registration Number
- NCT06185296
- Lead Sponsor
- Aalborg University Hospital
- Brief Summary
The trial is an open-label, randomized controlled trial. Patients with T2D on insulin therapy will be randomized to an intelligent telemonitoring group (intervention), a telemonitoring group (control), and a usual care group (control). Both the intelligent telemonitoring group and the telemonitoring group will use various devices at home. Hospital staff will monitor their data for six months. In the intelligent telemonitoring group, hospital staff and participants will be supported by decision-support algorithms in the management of insulin treatment.
- Detailed Description
The DiaTRUST trial is an open-label randomized controlled trial with a six-month trial period. The trial will be conducted at Steno Diabetes Center North Jutland. Patients with T2D on insulin therapy will be randomized (3:1:1) to an intelligent telemonitoring group (intervention), telemonitoring alone (control), or a usual care group (control). Both telemonitoring groups will use an insulin pen, an activity tracker, a CGM, and a smartphone application throughout the trial period. Hospital staff (lab technicians and nurses) will monitor the telemonitoring groups' data and contact the subjects by telephone repeatedly throughout the trial period. For patients assigned to the intelligent telemonitoring group, decision support algorithms will provide hospital staff with insight and data overviews to support treatment evaluation and adjustment throughout the trial. Furthermore, patients in the intelligent telemonitoring group will have access to algorithms through a smartphone application that can provide a risk assessment before bed of nocturnal hypoglycemia. The usual care group will use a blinded CGM for the first 20 days after inclusion, 20 days before the second visit to the trial site, and 20 days before the end of trial and will use a blinded insulin pen for the entire period. The usual care groups' data will not be monitored during the trial.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 51
- Adults ≥ 18 years.
- Diagnosis of T2D for at least 12 months prior to the day of screening.
- Patients who are being treated with insulin or about to start insulin treatment (insulin naïve) willing to travel to trial site in North Denmark to attend in-person visits.
- Have internet at home, have MitID, and willingness to use a smartphone and the other devices used in the trial
- Signed informed consent.
- Ability to understand and read Danish.
- Pregnancy or breastfeeding.
- Major surgery is planned during the trial period.
- Cancer diagnosis within five years prior to inclusion.
- Participation in other interventional trials.
- Limited literacy affecting the use of trial devices.
- Patient who has worn a CGM monitor less than 6 months prior to the trial.
- 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.
- Patients treated with mixed insulin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intelligent telemonitoring Intelligent telemonitoring The subjects will be telemonitored using the intelligent telemonitoring system. All subjects will use a CGM, a Fitbit, and a smart pen during the trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject) using the intelligent telemonitoring system with embedded decision support to facilitate treatment evaluation and adjustments. The subjects will have access to a smartphone app that is able to provide a risk for nocturnal hypoglycemia before bed. Telemonitoring Telemonitoring The subjects will be telemonitored. All subjects will use a CGM, a Fitbit, and a smart pen during the entire trial period. Staff at the endocrinology clinic will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject)
- Primary Outcome Measures
Name Time Method CGM time in range At baseline to six months after randomization Change in CGM time in range (3,9-10,0 mmol/L)
- Secondary Outcome Measures
Name Time Method Time in level 2 hyperglycemia At baseline to six months after randomization Change in CGM time above range (\>13.9 mmol/L)
Total daily units of insulin At baseline to six months after randomization Change in total daily dose of insulin (units)
Number of hypoglycemic episodes At baseline to six months after randomization Change in number of hypoglycemic episodes
Concentration of HbA1c At baseline to six months after randomization Change in HbA1c
Time in level 1 hypoglycemia At baseline to six months after randomization Change in CGM time below range (3.0-3.8 mmol/L)
Time in level 2 hypoglycemia At baseline to six months after randomization Change in CGM time below range (\<3.0 mmol/L)
Time in level 1 hyperglycemia At baseline to six months after randomization Change in CGM time above range (10.1-13.9 mmol/L)
CGM time in range At baseline to three months after randomization Change in CGM time in range (3,9-10,0 mmol/L)
Number of hyperglycemic episodes At baseline to six months after randomization Change in number of hyperglycemic episodes
Body weight At baseline to six months after randomization Change in body weight
Fear of hypoglycemia At baseline to six months after randomization Change in fear of hypoglycemia measured by Hypoglycemia Fear Survey-II short form (HFS-II short form) ranges from "never" to "almost always"
Diabetes-related quality of life From baseline to six months after randomization Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from "very negative" to "very positive"
Time-to-target At baseline to six months after randomization time until individualized treatment targets are reached
Change in patient adherence From baseline to six months after randomization Patient adherence measured by the Morisky Medication Adherence Scale (MMAS-8). Options are not numeric
Time efficiency At baseline to six months after randomization Between-group difference in time spent on contact with subjects and on treatment evaluation and adjustment by hospital staff
Health-related quality of life From baseline to six months after randomization Health-related quality of life measured by the European Quality of Life Five Dimension Questionnaire (EQ-5D). Options are not numeric in the descriptive part and follow the VAS scale in the second rating part ranging from 0 (The worst health you can image) to 100 (The best health you can image).
Satisfaction with telemonitoring solution at the six month assessment Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS)
Change in treatment satisfaction From baseline to six months after randomization Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Change in perceived competence in Diabetes From baseline to six months after randomization Perceived competence in Diabetes measured by the Perceived competence in Diabetes questionnaire (PCD)
Trial Locations
- Locations (1)
Department of Endocrinology
🇩🇰Aalborg, North jutland, Denmark