Clinical trial NCT06185296: The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy
Official title: The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Diabetes
Insulin
Telemedicine
Telehealth
Telemonitoring
CGM
Wearable devices
Adherence
Decision support
Algorithms
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: DexCom, Inc.
First posted: 2023-12-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: CGM time in range
timeFrame: At baseline to six months after randomization
Secondary outcomes:
measure: Concentration of HbA1c
timeFrame: At baseline to three months after randomization
measure: Concentration of HbA1c
timeFrame: At baseline to six months after randomization
measure: CGM time in range
timeFrame: At baseline to three months after randomization
measure: Time in level 1 hypoglycemia
timeFrame: At baseline to three months after randomization
measure: Time in level 1 hypoglycemia
timeFrame: At baseline to six months after randomization
measure: Time in level 2 hypoglycemia
timeFrame: At baseline to three months after randomization
measure: Time in level 2 hypoglycemia
timeFrame: At baseline to six months after randomization
measure: Time in level 1 hyperglycemia
timeFrame: At baseline to three months after randomization
measure: Time in level 1 hyperglycemia
timeFrame: At baseline to six months after randomization
measure: Time in level 2 hyperglycemia
timeFrame: At baseline to three months after randomization
measure: Time in level 2 hyperglycemia
timeFrame: At baseline to six months after randomization
measure: Total daily units of insulin
timeFrame: At baseline to three months after randomization
measure: Total daily units of insulin
timeFrame: At baseline to six months after randomization
measure: Number of hypoglycemic episodes
timeFrame: At baseline to three months after randomization
measure: Number of hypoglycemic episodes
timeFrame: At baseline to six months after randomization
measure: Number of hyperglycemic episodes
timeFrame: At baseline to three months after randomization
measure: Number of hyperglycemic episodes
timeFrame: At baseline to six months after randomization
measure: Body weight
timeFrame: At baseline to three months after randomization
measure: Body weight
timeFrame: At baseline to six months after randomization
measure: Time-to-target
timeFrame: At baseline to six months after randomization
measure: Time efficiency
timeFrame: At baseline to six months after randomization
measure: Fear of hypoglycemia
timeFrame: At baseline to six months after randomization
measure: Diabetes-related quality of life
timeFrame: From baseline to six months after randomization
measure: Health-related quality of life
timeFrame: From baseline to six months after randomization
measure: Change in patient adherence
timeFrame: From baseline to three months after randomization
measure: Change in patient adherence
timeFrame: From baseline to six months after randomization
measure: Satisfaction with telemonitoring solution
timeFrame: at the six month assessment
measure: Change in treatment satisfaction
timeFrame: From baseline to six months after randomization
measure: Change in perceived competence in Diabetes
timeFrame: From baseline to six months after randomization
Other outcomes:
measure: Number of CGM days worn
timeFrame: During the intervention and active comparator
measure: CGM percentage of time active
timeFrame: During the intervention and active comparator
measure: Mean glucose
timeFrame: At baseline to three months after randomization
measure: Mean glucose
timeFrame: At baseline to six months after randomization
measure: Glycemic variability
timeFrame: At baseline to three months after randomization
measure: Glycemic variability
timeFrame: At baseline to six months after randomization
measure: Use of the telemonitoring equipment
timeFrame: Through study completion, an average of 6 months
measure: Glucose management indicator
timeFrame: At baseline to three months after randomization
measure: Glucose management indicator
timeFrame: At baseline to six months after randomization
measure: Self-reported adherence
timeFrame: Through study completion, an average of 6 months
measure: Dietary habits
timeFrame: At baseline to six months after randomization
measure: Exercise habits
timeFrame: At baseline to six months after randomization
measure: Self-reported information on diet and exercise habits
timeFrame: Through study completion, an average of 6 months
measure: Insulin doses
timeFrame: Through study completion, an average of 6 months
measure: Insulin dosing time
timeFrame: Through study completion, an average of 6 months
Locations:
city: Aalborg
country: Denmark
facility: Department of Endocrinology
state: North jutland
Study officials:
affiliation: Steno Diabetes Center North Denmark
name: Peter Vestergaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: