The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Intelligent telemonitoring
- Conditions
- Not specified
- Sponsor
- Aalborg University Hospital
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- CGM time in range
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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 three 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 three-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.
Investigators
Peter Vestergaard
MD, professor
Aalborg University Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Intelligent 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)
Intervention: Telemonitoring
Usual care
The subjects will wear a blinded CGM the first 20 days after inclusion, 20 days before the second visit to the trial site, and the final 20 days of the trial. The subjects will use a blinded smart pen throughout the trial period. Hence, the subjects cannot see their measured data during the trial and will not be monitored.
Outcomes
Primary Outcomes
CGM time in range
Time Frame: At baseline to three months after randomization
Change in CGM time in range (3,9-10,0 mmol/L)
Secondary Outcomes
- Concentration of HbA1c(At baseline to three months after randomization)
- CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L)(At baseline to three months after randomization)
- CGM time in level 2 hypoglycemia (<3.0 mmol/L)(At baseline to three months after randomization)
- CGM time in level 1 hyperglycemia (10.1-13.9 mmol/L)(At baseline to three months after randomization)
- CGM time in level 2 hyperglycemia (>13.9 mmol/L)(At baseline to three months after randomization)
- Total daily units of insulin(At baseline to three months after randomization)
- Number of hypoglycemic episodes(At baseline to three months after randomization)
- Number of hyperglycemic episodes(At baseline to three months after randomization)
- Body weight(At baseline to three months after randomization)
- Use of the telemonitoring equipment(Through study completion, an average of three months)
- Time-to-target(At baseline to three months after randomization)
- Time efficiency(At baseline to three months after randomization)
- Fear of hypoglycemia(At baseline to three months after randomization)
- Diabetes-related quality of life(From baseline to three months after randomization)
- Health-related quality of life(From baseline to three months after randomization)
- Change in patient adherence(From baseline to three months after randomization)
- Satisfaction with telemonitoring solution(At the three month assessment)
- Change in treatment satisfaction(From baseline to three months after randomization)
- Change in perceived competence in Diabetes(From baseline to three months after randomization)
- Change in CGM(Three months after randomization)