Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT)

The Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT) 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 a telemonitoring group (intervention) and a usual care group (control). The telemonitoring group will use various devices at home. Hospital staff will monitor their data for a period of three months.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: Telemonitoring

Detailed Description

The DiaMonT trial is an open-label randomized controlled trial with a trial period of three months conducted. The trial will be conducted in two sites in Denmark: Steno Diabetes Center North Jutland and Steno Diabetes Center Zealand. Patients with T2D on insulin therapy will be randomized (1:1) to a telemonitoring group (intervention) or a usual care group (control). The telemonitoring group 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. The usual care group will use a blinded CGM the first and last 20 days of the 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 (Actual): 331
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stine Hangaard, PhD; Phone Number: 22444242; Email: svh@hst.aau.dk
• Study Contact Backup: Name: Morten Jensen, PhD; Phone Number: 22226964; Email: mhj@hst.aau.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Department of Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 years
• T2D diagnosis for ≥ 12 months
• Residence in Region North Denmark or Region Zealand
• In treatment with insulin
• Being able to use a smartphone along with the other devices to be used in the trial
• Able to understand and read Danish.

Exclusion Criteria:

• Pregnancy or breastfeeding,
• Major surgery planned during the trial period
• Participation in other trials
• Terms that, in the opinion of the investigator or subinvestigators, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemonitoring; The subjects will be telemonitored. All subject will use a CGM, a fit bit, and a smart pen during the entire trial period. Staff at the endocinology clinics will monitor the data and contact the subjects continuously throughout the trial (depending on the individual needs of each subject)	Device: Telemonitoring; Telemonitoring of CGM and insulin pen data
No Intervention: Usual Care; The subjects will wear a blinded CGM the first and final 20 days of the trial. The subjects will use a blinded smart pen throughout the trial period. Hence, the subjects are unable to see their measured data during the trial, and they 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 three 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
Total daily units of insulin	Change in total daily dose of insulin (units)	At baseline to three months after randomization
Time below CGM range	Change in time below range (CGM)	At baseline to three months after randomization
Time above CGM range	Change in time above range (CGM)	At baseline to three months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of CGM days worn	Number of days that the subjects wear the CGM	During the intervention
CGM percentage of time active	Percentage of time that the CGM is active	During the intervention
Mean glucose	Mean glucose levels (mmol/l) measured by CGM	At baseline to three months after randomization
Glycemic variability	Glycemic variability - percentage of cofficient of variation	At baseline to three months after randomization
Time in hyperglycemia	Time in hyperglycemia (>13,9 mmol/L)	At baseline to three months after randomization
Time in hypoglycemia	Time in hypoglycemia (<3,0 mmol/L)	At baseline to three months after randomization
Episodes of hyperglycemia	Number of episodes of hyperglycemia (>13,9 mmol/L)	At baseline to three months after randomization
Episodes of hypoglycemia	Number of episodes in hypoglycemia	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 3 months
Telemonitoring usability	Telemonitoring satisfaction and usability measured by the Telemonitoring Usability Questionnaire (TUQ). Minimum value =1, maximum value =7. A higher score = a better outcome	Immediately after the intervention
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 Short Form 12 (SF-12). Options are not numeric	From baseline to three months after randomization

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Novo Nordisk A/S; DexCom, Inc.; Steno Diabetes Center Sjaelland; Glooko

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): November 24, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Adherence; Telemedicine; Telemonitoring; Telehealth; CGM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: N-20200068

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