Type 2 Diabetes Treated With Insulin
Conditions
Keywords
Diabetes, Insulin, Telemedicine, Telehealth, Telemonitoring, CGM, Wearable devices, Adherence, Decision support, Algorithms
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.
Interventions
DEVICEIntelligent telemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
DEVICETelemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data
Sponsors
Aalborg University Hospital
Novo Nordisk A/S
DexCom, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGM time in range | At baseline to three months after randomization | Change in CGM time in range (3,9-10,0 mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of HbA1c | At baseline to three months after randomization | Change in HbA1c |
| CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L) | At baseline to three months after randomization | Change in CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L) |
| CGM time in level 2 hypoglycemia (<3.0 mmol/L) | At baseline to three months after randomization | Change in CGM time in level 2 hypoglycemia (\<3.0 mmol/L) |
| CGM time in level 1 hyperglycemia (10.1-13.9 mmol/L) | At baseline to three months after randomization | Change in CGM time above range (10.1-13.9 mmol/L) |
| CGM time in level 2 hyperglycemia (>13.9 mmol/L) | At baseline to three months after randomization | Change in CGM time above range (\>13.9 mmol/L) |
| Total daily units of insulin | At baseline to three months after randomization | Change in total daily dose of insulin (units) |
| Number of hypoglycemic episodes | At baseline to three months after randomization | Change in number of hypoglycemic episodes |
| Number of hyperglycemic episodes | At baseline to three months after randomization | Change in number of hyperglycemic episodes |
| Body weight | At baseline to three months after randomization | Change in body weight |
| Use of the telemonitoring equipment | Through study completion, an average of three months | The frequency of use of the telemonitoring equipment |
| Time-to-target | At baseline to three months after randomization | time until individualized treatment targets are reached |
| Time efficiency | At baseline to three months after randomization | Between-group difference in time spent on contact with subjects and on treatment evaluation and adjustment by hospital staff |
| Fear of hypoglycemia | At baseline to three 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 three months after randomization | Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from "very negative" to "very positive" |
| Health-related quality of life | From baseline to three months after randomization | Health-related quality of life measured by the European Quality of Life Five Dimension Questionnaire (EQ-5D-5L). 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). |
| Change in patient adherence | From baseline to three months after randomization | Patient adherence measured by the Insulin Adherence Questionnaire. Options are not numeric |
| Satisfaction with telemonitoring solution | At the three month assessment | Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS) |
| Change in treatment satisfaction | From baseline to three months after randomization | Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
| Change in perceived competence in Diabetes | From baseline to three months after randomization | Perceived competence in Diabetes measured by the Perceived competence in Diabetes questionnaire (PCD) |
| Change in CGM | Three months after randomization | Change from baseline in CGM time in level 2 hypoglycemia (\<3.0 mmol/L) |
Countries
Denmark
Contacts
CONTACTJannie Nørlev, PhD
CONTACTStine Hangaard, PhD
PRINCIPAL_INVESTIGATORPeter Vestergaard, MD, PhD
Steno Diabetes Center North Denmark
Outcome results
None listed