Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| DexCom, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intelligent telemonitoring | Experimental | 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 | Active Comparator | 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) |
|
| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intelligent telemonitoring | Device | Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CGM time in range | Change in CGM time in range (3,9-10,0 mmol/L) | At baseline to three months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of HbA1c | Change in HbA1c | At baseline to three months after randomization |
| CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L) | Change in CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported adherence | Self-reported adherence insights from contacts between hospital staff and patients during the trial in the telemonitoring groups. Topics of conversation related to self-reported adherence will be collected based on predefined themes (e.g., missing basal dose due to forgetfulness, varying basal insulin dose during a week due to error on smartpen). | Through study completion, an average of 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jannie Nørlev, PhD | Contact | 004523676513 | jadano@hst.aau.dk | |
| Stine Hangaard, PhD | Contact | svh@hst.aau.dk |
| Name | Affiliation | Role |
|---|---|---|
| Peter Vestergaard, MD, PhD | Steno Diabetes Center North Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology | Recruiting | Aalborg | North Jutland | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39511648 | Derived | Thomsen CHN, Norlev JTD, Hangaard S, Jensen MH, Hejlesen O, Cohen SR, Kofoed-Enevoldsen A, Kristensen SNS, Aradottir TB, Kaas A, Vestergaard P, Kronborg T. The intelligent diabetes telemonitoring using decision support to treat patients on insulin therapy (DiaTRUST) trial: study protocol for a randomized controlled trial. Trials. 2024 Nov 8;25(1):744. doi: 10.1186/s13063-024-08588-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Telemonitoring | Device | Telemonitoring using CGM, insulin pen data, and Fitbit data |
|
| At baseline to three months after randomization |
| CGM time in level 2 hypoglycemia (<3.0 mmol/L) | Change in 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) | Change in CGM time above range (10.1-13.9 mmol/L) | At baseline to three months after randomization |
| CGM time in level 2 hyperglycemia (>13.9 mmol/L) | Change in CGM time above range (>13.9 mmol/L) | At baseline to three months after randomization |
| Total daily units of insulin | Change in total daily dose of insulin (units) | At baseline to three months after randomization |
| Number of hypoglycemic episodes | Change in number of hypoglycemic episodes | At baseline to three months after randomization |
| Number of hyperglycemic episodes | Change in number of hyperglycemic episodes | At baseline to three months after randomization |
| Body weight | Change in body weight | At baseline to three months after randomization |
| Use of the telemonitoring equipment | The frequency of use of the telemonitoring equipment | Through study completion, an average of three months |
| Time-to-target | time until individualized treatment targets are reached | At baseline to three months after randomization |
| Time efficiency | Between-group difference in time spent on contact with subjects and on treatment evaluation and adjustment by hospital staff | At baseline to three months after randomization |
| Fear of hypoglycemia | Change in fear of hypoglycemia measured by Hypoglycemia Fear Survey-II short form (HFS-II short form) ranges from "never" to "almost always" | At baseline to three months after randomization |
| Diabetes-related quality of life | Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from "very negative" to "very positive" | From baseline to three months after randomization |
| Health-related quality of life | 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). | From baseline to three months after randomization |
| Change in patient adherence | Patient adherence measured by the Insulin Adherence Questionnaire. Options are not numeric | From baseline to three months after randomization |
| Satisfaction with telemonitoring solution | Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS) | At the three month assessment |
| Change in treatment satisfaction | Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) | From baseline to three months after randomization |
| Change in perceived competence in Diabetes | Perceived competence in Diabetes measured by the Perceived competence in Diabetes questionnaire (PCD) | From baseline to three months after randomization |
| Change in CGM | Change from baseline in CGM time in level 2 hypoglycemia (<3.0 mmol/L) | Three months after randomization |
| Insulin doses | Any differences in the use of insulin in terms of dosing between the three groups are examined based on data from the insulin pens, e.g., differences in the amount of insulin taken per patient (measured by units per insulin type), and differences in change in insulin dose during the trial period (measured by units). | Through study completion, an average of 6 months |
| Insulin dosing time | Any differences in the use of insulin in terms of timing of the dosing between the three groups are examined based on data from the insulin pens, e.g., differences in injection patterns. | Through study completion, an average of 6 months |
| Number of CGM days worn | Number of days that the subjects wear the CGM | During the intervention and active comparator |
| CGM percentage of time active | Percentage of time that the CGM is active | During the intervention and active comparator |
| Mean glucose | Mean glucose levels (mmol/l) measured by CGM | At baseline to three months after randomization |
| Glycemic variability | Glycemic variability - percentage of coefficient of variation | At baseline to three months after randomization |
| Glucose management indicator | Change in estimated A1c (%) derived from CGM | At baseline to three months after randomization |
| Dietary habits | Change in diet habits collected by predefined questions. Options are not numeric. | At baseline to three months after randomization |
| Exercise habits | Change in exercise habits collected by predefined questions. Options are not numeric. | At baseline to three months after randomization |
| Self-reported information on diet and exercise habits | Self-reported information on diet and exercise habits collected from the contacts between hospital staff and patients throughout the trial period. Notes will be collected based on these conservations on e.g., the patient's realising impact of certain foods in blood glucose variations, patient and hospital staff agree to try reach a higher number of steps per day. | Through study completion, an average of 3 months |
| D006946 | Hyperinsulinism |