The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Intelligent Diabetes TelemonitoRing Using Decision Support to Treat Patients on Insulin Trial: Study Protocol for a Randomized Controlled Trial

Conditions
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Type 2 Diabetes Treated With Insulin

Intervention / Treatment
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* Device: Intelligent telemonitoring
* Device: Telemonitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intelligent telemonitoring<br>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. | Device: Intelligent telemonitoring<br>* Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.<br>|
| Active Comparator: Telemonitoring<br>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) | Device: Telemonitoring<br>* Telemonitoring using CGM, insulin pen data, and Fitbit data<br>|
| No Intervention: Usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGM time in range | Change in CGM time in range (3,9-10,0 mmol/L) | At baseline to six months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of HbA1c | Change in HbA1c | At baseline to three months after randomization | 
| Concentration of HbA1c | Change in HbA1c | At baseline to six months after randomization | 
| CGM time in range | Change in CGM time in range (3,9-10,0 mmol/L) | At baseline to three months after randomization | 
| Time in level 1 hypoglycemia | Change in CGM time below range (3.0-3.8 mmol/L) | At baseline to three months after randomization | 
| Time in level 1 hypoglycemia | Change in CGM time below range (3.0-3.8 mmol/L) | At baseline to six months after randomization | 
| Time in level 2 hypoglycemia | Change in CGM time below range (<3.0 mmol/L) | At baseline to three months after randomization | 
| Time in level 2 hypoglycemia | Change in CGM time below range (<3.0 mmol/L) | At baseline to six months after randomization | 
| Time in level 1 hyperglycemia | Change in CGM time above range (10.1-13.9 mmol/L) | At baseline to three months after randomization | 
| Time in level 1 hyperglycemia | Change in CGM time above range (10.1-13.9 mmol/L) | At baseline to six months after randomization | 
| Time in level 2 hyperglycemia | Change in CGM time above range (>13.9 mmol/L) | At baseline to three months after randomization | 
| Time in level 2 hyperglycemia | Change in CGM time above range (>13.9 mmol/L) | At baseline to six months after randomization | 
| Total daily units of insulin | Change in total daily dose of insulin (units) | At baseline to three months after randomization | 
| Total daily units of insulin | Change in total daily dose of insulin (units) | At baseline to six months after randomization | 
| Number of hypoglycemic episodes | Change in number of hypoglycemic episodes | At baseline to three months after randomization | 
| Number of hypoglycemic episodes | Change in number of hypoglycemic episodes | At baseline to six months after randomization | 
| Number of hyperglycemic episodes | Change in number of hyperglycemic episodes | At baseline to three months after randomization | 
| Number of hyperglycemic episodes | Change in number of hyperglycemic episodes | At baseline to six months after randomization | 
| Body weight | Change in body weight | At baseline to three months after randomization | 
| Body weight | Change in body weight | At baseline to six months after randomization | 
| Time-to-target | time until individualized treatment targets are reached | At baseline to six 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 six 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 six 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 six months after randomization | 
| Health-related quality of life | Health-related quality of life measured by the Short Form 12 (SF-12). Options are not numeric | From baseline to six months after randomization | 
| Change in patient adherence | Patient adherence measured by the Morisky Medication Adherence Scale (MMAS-8). Options are not numeric | From baseline to three months after randomization | 
| Change in patient adherence | Patient adherence measured by the Morisky Medication Adherence Scale (MMAS-8). Options are not numeric | From baseline to six months after randomization | 
| Satisfaction with telemonitoring solution | Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS) | at the six month assessment | 
| Change in treatment satisfaction | Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) | From baseline to six 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 six months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin, Telemedicine, Telehealth, Telemonitoring, CGM, Wearable devices, Adherence, Decision support, Algorithms