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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: Intelligent telemonitoring; Device: Telemonitoring

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.

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camilla Thomsen; Phone Number: 004530646241; Email: chnt@hst.aau.dk
• Study Contact Backup: Name: Thomas Larsen; Phone Number: 004525617380; Email: tkl@hst.aau.dk

Study Locations

• Denmark
  • North Jutland
    • Aalborg, North Jutland, Denmark, 9000
      • Department of Endocrinology
      • Contact: Katrine Vogensen; Phone Number: 004524794472; Email: k.vogensen@rn.dk
      • Principal Investigator: Peter Vestergaard, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Intelligent telemonitoring; Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
Active Comparator: 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)	Device: Telemonitoring; Telemonitoring using CGM, insulin pen data, and Fitbit data
No Intervention: 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.

What is the study measuring?

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
CGM time in range	Change in CGM time in range (3,9-10,0 mmol/L)	At baseline to three months after randomization
Concentration of HbA1c	Change in HbA1c	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
Concentration of HbA1c	Change in HbA1c	At baseline to six 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 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
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
Health-related quality of life	Health-related quality of life measured by the European Quality of Life Five Dimension Questionnaire (EQ-5D). 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 six months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose	Mean glucose levels (mmol/l) measured by CGM	At baseline to three months after randomization
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 six months after randomization
Glycemic variability	Glycemic variability - percentage of coefficient of variation	At baseline to three months after randomization
Glycemic variability	Glycemic variability - percentage of coefficient of variation	At baseline to six months after randomization
Use of the telemonitoring equipment	The frequency of use of the telemonitoring equipment	Through study completion, an average of 6 months
Glucose management indicator	Change in estimated A1c (%) derived from CGM	At baseline to three months after randomization
Glucose management indicator	Change in estimated A1c (%) derived from CGM	At baseline to six months after randomization
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
Dietary habits	Change in diet habits collected by predefined questions. Options are not numeric.	At baseline to six months after randomization
Exercise habits	Change in exercise habits collected by predefined questions. Options are not numeric.	At baseline to six 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 6 months
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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Novo Nordisk A/S; DexCom, Inc.
• Investigators: Principal Investigator: Peter Vestergaard, MD, PhD, Steno Diabetes Center North Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Adherence; Telemedicine; Telemonitoring; Telehealth; CGM; Algorithms; Wearable devices; Decision support
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: DiaTRUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No