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

Type 2 Diabetes Treated With Insulin Clinical Trial

— DiaTRUST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185296
• Other study ID #: DiaTRUST
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Aalborg University Hospital
• Contact: Camilla Thomsen
• Phone: 004530646241
• Email: chnt[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes Treated With Insulin

Intervention

Device:
• Intelligent telemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data supported by data-driven decision support.
• Telemonitoring
Telemonitoring using CGM, insulin pen data, and Fitbit data

Locations

Country	Name	City	State
Denmark	Department of Endocrinology	Aalborg	North Jutland

Sponsors (3)

Lead Sponsor	Collaborator
Aalborg University Hospital	DexCom, Inc., Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of CGM days worn	Number of days that the subjects wear the CGM	During the intervention and active comparator
Other	CGM percentage of time active	Percentage of time that the CGM is active	During the intervention and active comparator
Other	Mean glucose	Mean glucose levels (mmol/l) measured by CGM	At baseline to three months after randomization
Other	Mean glucose	Mean glucose levels (mmol/l) measured by CGM	At baseline to six months after randomization
Other	Glycemic variability	Glycemic variability - percentage of coefficient of variation	At baseline to three months after randomization
Other	Glycemic variability	Glycemic variability - percentage of coefficient of variation	At baseline to six months after randomization
Other	Use of the telemonitoring equipment	The frequency of use of the telemonitoring equipment	Through study completion, an average of 6 months
Other	Glucose management indicator	Change in estimated A1c (%) derived from CGM	At baseline to three months after randomization
Other	Glucose management indicator	Change in estimated A1c (%) derived from CGM	At baseline to six months after randomization
Other	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
Other	Dietary habits	Change in diet habits collected by predefined questions. Options are not numeric.	At baseline to six months after randomization
Other	Exercise habits	Change in exercise habits collected by predefined questions. Options are not numeric.	At baseline to six months after randomization
Other	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
Other	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
Other	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
Primary	CGM time in range	Change in CGM time in range (3,9-10,0 mmol/L)	At baseline to six months after randomization
Secondary	Concentration of HbA1c	Change in HbA1c	At baseline to three months after randomization
Secondary	Concentration of HbA1c	Change in HbA1c	At baseline to six months after randomization
Secondary	CGM time in range	Change in CGM time in range (3,9-10,0 mmol/L)	At baseline to three months after randomization
Secondary	Time in level 1 hypoglycemia	Change in CGM time below range (3.0-3.8 mmol/L)	At baseline to three months after randomization
Secondary	Time in level 1 hypoglycemia	Change in CGM time below range (3.0-3.8 mmol/L)	At baseline to six months after randomization
Secondary	Time in level 2 hypoglycemia	Change in CGM time below range (<3.0 mmol/L)	At baseline to three months after randomization
Secondary	Time in level 2 hypoglycemia	Change in CGM time below range (<3.0 mmol/L)	At baseline to six months after randomization
Secondary	Time in level 1 hyperglycemia	Change in CGM time above range (10.1-13.9 mmol/L)	At baseline to three months after randomization
Secondary	Time in level 1 hyperglycemia	Change in CGM time above range (10.1-13.9 mmol/L)	At baseline to six months after randomization
Secondary	Time in level 2 hyperglycemia	Change in CGM time above range (>13.9 mmol/L)	At baseline to three months after randomization
Secondary	Time in level 2 hyperglycemia	Change in CGM time above range (>13.9 mmol/L)	At baseline to six months after randomization
Secondary	Total daily units of insulin	Change in total daily dose of insulin (units)	At baseline to three months after randomization
Secondary	Total daily units of insulin	Change in total daily dose of insulin (units)	At baseline to six months after randomization
Secondary	Number of hypoglycemic episodes	Change in number of hypoglycemic episodes	At baseline to three months after randomization
Secondary	Number of hypoglycemic episodes	Change in number of hypoglycemic episodes	At baseline to six months after randomization
Secondary	Number of hyperglycemic episodes	Change in number of hyperglycemic episodes	At baseline to three months after randomization
Secondary	Number of hyperglycemic episodes	Change in number of hyperglycemic episodes	At baseline to six months after randomization
Secondary	Body weight	Change in body weight	At baseline to three months after randomization
Secondary	Body weight	Change in body weight	At baseline to six months after randomization
Secondary	Time-to-target	time until individualized treatment targets are reached	At baseline to six months after randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Satisfaction with telemonitoring solution	Satisfaction with telemonitoring solution measured by Digital Health Solution Satisfaction questionnaire (DHSS)	at the six month assessment
Secondary	Change in treatment satisfaction	Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)	From baseline to six months after randomization
Secondary	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