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Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT)

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ClinicalTrials.gov Identifier: NCT04981808
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : February 16, 2022
Sponsor:
Collaborators:
Steno Diabetes Center Sjaelland
Novo Nordisk A/S
Glooko
DexCom, Inc.
Information provided by (Responsible Party):
Peter Vestergaard, Aalborg University Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Treated With Insulin Device: Telemonitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Diabetes teleMonitoring of Patients in Insulin Therapy (DiaMonT) Trial: Study Protocol for a Randomized Controlled Trial
Actual Study Start Date : August 18, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

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.



Primary Outcome Measures :
  1. CGM time in range [ Time Frame: At baseline to three months after randomization ]
    Change in CGM time in range (3,9-10,0 mmol/L)


Secondary Outcome Measures :
  1. Concentration of HbA1c [ Time Frame: At baseline to three months after randomization ]
    Change in HbA1c

  2. Total daily units of insulin [ Time Frame: At baseline to three months after randomization ]
    Change in total daily dose of insulin (units)

  3. Time below CGM range [ Time Frame: At baseline to three months after randomization ]
    Change in time below range (CGM)

  4. Time above CGM range [ Time Frame: At baseline to three months after randomization ]
    Change in time above range (CGM)


Other Outcome Measures:
  1. Number of CGM days worn [ Time Frame: During the intervention ]
    Number of days that the subjects wear the CGM

  2. CGM percentage of time active [ Time Frame: During the intervention ]
    Percentage of time that the CGM is active

  3. Mean glucose [ Time Frame: At baseline to three months after randomization ]
    Mean glucose levels (mmol/l) measured by CGM

  4. Glycemic variability [ Time Frame: At baseline to three months after randomization ]
    Glycemic variability - percentage of cofficient of variation

  5. Time in hyperglycemia [ Time Frame: At baseline to three months after randomization ]
    Time in hyperglycemia (>13,9 mmol/L)

  6. Time in hypoglycemia [ Time Frame: At baseline to three months after randomization ]
    Time in hypoglycemia (<3,0 mmol/L)

  7. Episodes of hyperglycemia [ Time Frame: At baseline to three months after randomization ]
    Number of episodes of hyperglycemia (>13,9 mmol/L)

  8. Episodes of hypoglycemia [ Time Frame: At baseline to three months after randomization ]
    Number of episodes in hypoglycemia

  9. Use of the telemonitoring equipment [ Time Frame: Through study completion, an average of 3 months ]
    The frequency of use of the telemonitoring equipment

  10. Telemonitoring usability [ Time Frame: Immediately after the intervention ]
    Telemonitoring satisfaction and usability measured by the Telemonitoring Usability Questionnaire (TUQ). Minimum value =1, maximum value =7. A higher score = a better outcome

  11. Diabetes-related quality of life [ Time Frame: From baseline to three months after randomization ]
    Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from "very negative" to "very positive"

  12. Health-related quality of life [ Time Frame: From baseline to three months after randomization ]
    Health-related quality of life measured by the Short Form 12 (SF-12). Options are not numeric



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981808


Contacts
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Contact: Stine Hangaard, PhD 22444242 svh@hst.aau.dk
Contact: Morten Jensen, PhD 22226964 mhj@hst.aau.dk

Locations
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Denmark
Department of Endocrinology Recruiting
Aalborg, Denmark, 9000
Contact: Katrine Vogensen    24794472    k.vogensen@rn.dk   
Principal Investigator: Peter Vestergaard, PhD         
Sponsors and Collaborators
Aalborg University Hospital
Steno Diabetes Center Sjaelland
Novo Nordisk A/S
Glooko
DexCom, Inc.
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Responsible Party: Peter Vestergaard, MD, professor, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04981808    
Other Study ID Numbers: N-20200068
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Vestergaard, Aalborg University Hospital:
Diabetes
Insulin
Telemedicine
Telehealth
Telemonitoring
CGM
Adherence
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases