Diabetes teleMonitoring of Patients in Insulin Therapy

Type 2 Diabetes Treated With Insulin Clinical Trial

— DiaMonT  

Official title:

The Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT) Trial: Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981808
• Other study ID #: N-20200068
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: November 24, 2023

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: n/a
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes Treated With Insulin

Intervention

Device:
• Telemonitoring
Telemonitoring of CGM and insulin pen data

Locations

Country	Name	City	State
Denmark	Department of Endocrinology	Aalborg

Sponsors (5)

Lead Sponsor	Collaborator
Aalborg University Hospital	DexCom, Inc., Glooko, Novo Nordisk A/S, Steno Diabetes Center Sjaelland

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
Other	CGM percentage of time active	Percentage of time that the CGM is active	During the intervention
Other	Mean glucose	Mean glucose levels (mmol/l) measured by CGM	At baseline to three months after randomization
Other	Glycemic variability	Glycemic variability - percentage of cofficient of variation	At baseline to three months after randomization
Other	Time in hyperglycemia	Time in hyperglycemia (>13,9 mmol/L)	At baseline to three months after randomization
Other	Time in hypoglycemia	Time in hypoglycemia (<3,0 mmol/L)	At baseline to three months after randomization
Other	Episodes of hyperglycemia	Number of episodes of hyperglycemia (>13,9 mmol/L)	At baseline to three months after randomization
Other	Episodes of hypoglycemia	Number of episodes in hypoglycemia	At baseline to three months after randomization
Other	Use of the telemonitoring equipment	The frequency of use of the telemonitoring equipment	Through study completion, an average of 3 months
Other	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
Other	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
Other	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
Primary	CGM time in range	Change in CGM time in range (3,9-10,0 mmol/L)	At baseline to three months after randomization
Secondary	Concentration of HbA1c	Change in HbA1c	At baseline to three 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	Time below CGM range	Change in time below range (CGM)	At baseline to three months after randomization
Secondary	Time above CGM range	Change in time above range (CGM)	At baseline to three months after randomization