NCT04981808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

August 18, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2.3 years

First QC Date

June 8, 2021

Last Update Submit

January 30, 2024

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

DiabetesInsulinTelemedicineTelehealthTelemonitoringCGMAdherence

Outcome Measures

Primary Outcomes (1)

  • CGM time in range

    Change in CGM time in range (3,9-10,0 mmol/L)

    At baseline to three months after randomization

Secondary Outcomes (4)

  • Concentration of HbA1c

    At baseline to three months after randomization

  • Total daily units of insulin

    At baseline to three months after randomization

  • Time below CGM range

    At baseline to three months after randomization

  • Time above CGM range

    At baseline to three months after randomization

Other Outcomes (12)

  • Number of CGM days worn

    During the intervention

  • CGM percentage of time active

    During the intervention

  • Mean glucose

    At baseline to three months after randomization

  • +9 more other outcomes

Study Arms (2)

Telemonitoring

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

TelemonitoringDEVICE

Telemonitoring of CGM and insulin pen data

Telemonitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology

Aalborg, 9000, Denmark

Location

Related Publications (1)

  • Hangaard S, Kronborg T, Hejlesen O, Aradottir TB, Kaas A, Bengtsson H, Vestergaard P, Jensen MH. The Diabetes teleMonitoring of patients in insulin Therapy (DiaMonT) trial: study protocol for a randomized controlled trial. Trials. 2022 Dec 7;23(1):985. doi: 10.1186/s13063-022-06921-6.

    PMID: 36476605DERIVED

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor

Study Record Dates

First Submitted

June 8, 2021

First Posted

July 29, 2021

Study Start

August 18, 2021

Primary Completion

November 24, 2023

Study Completion

November 24, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)