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

Official title

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

Overview

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

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

Primary outcome measures

• CGM time in range [Time frame: At baseline to three months after randomization]

Secondary outcome measures (12)

• Concentration of HbA1c [Time frame: At baseline to three months after randomization]
• CGM time in level 1 hypoglycemia (3.0-3.8 mmol/L) [Time frame: At baseline to three months after randomization]
• CGM time in level 2 hypoglycemia (<3.0 mmol/L) [Time frame: At baseline to three months after randomization]
• CGM time in level 1 hyperglycemia (10.1-13.9 mmol/L) [Time frame: At baseline to three months after randomization]
• CGM time in level 2 hyperglycemia (>13.9 mmol/L) [Time frame: At baseline to three months after randomization]
• Total daily units of insulin [Time frame: At baseline to three months after randomization]
• Number of hypoglycemic episodes [Time frame: At baseline to three months after randomization]
• Number of hyperglycemic episodes [Time frame: At baseline to three months after randomization]
• Body weight [Time frame: At baseline to three months after randomization]
• Use of the telemonitoring equipment [Time frame: Through study completion, an average of three months]
• Time-to-target [Time frame: At baseline to three months after randomization]
• Time efficiency [Time frame: At baseline to three months after randomization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Department of Endocrinology — Aalborg

Publications

• 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. PMID 39511648

Identifiers

NCT: NCT06185296 · DiaTRUST

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗