Type 2 Diabetes Treated With Insulin
Conditions
Keywords
Diabetes, Insulin, Telemedicine, Telehealth, Telemonitoring, CGM, Adherence
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.
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.
Interventions
DEVICETelemonitoring
Telemonitoring of CGM and insulin pen data
Sponsors
Steno Diabetes Center Sjaelland
Novo Nordisk A/S
Glooko
DexCom, Inc.
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGM time in range | At baseline to three months after randomization | Change in CGM time in range (3,9-10,0 mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of HbA1c | At baseline to three months after randomization | Change in HbA1c |
| Total daily units of insulin | At baseline to three months after randomization | Change in total daily dose of insulin (units) |
| Time below CGM range | At baseline to three months after randomization | Change in time below range (CGM) |
| Time above CGM range | At baseline to three months after randomization | Change in time above range (CGM) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean glucose | At baseline to three months after randomization | Mean glucose levels (mmol/l) measured by CGM |
| Glycemic variability | At baseline to three months after randomization | Glycemic variability - percentage of cofficient of variation |
| Time in hyperglycemia | At baseline to three months after randomization | Time in hyperglycemia (\>13,9 mmol/L) |
| Episodes of hypoglycemia | At baseline to three months after randomization | Number of episodes in hypoglycemia |
| Telemonitoring usability | 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 |
| Diabetes-related quality of life | From baseline to three months after randomization | Diabetes-related quality of life measured by the DIDP Questionnaire. Ranges from very negative to very positive |
| Health-related quality of life | From baseline to three months after randomization | Health-related quality of life measured by the Short Form 12 (SF-12). Options are not numeric |
| Use of the telemonitoring equipment | Through study completion, an average of 3 months | The frequency of use of the telemonitoring equipment |
| Time in hypoglycemia | At baseline to three months after randomization | Time in hypoglycemia (\<3,0 mmol/L) |
| Episodes of hyperglycemia | At baseline to three months after randomization | Number of episodes of hyperglycemia (\>13,9 mmol/L) |
| Number of CGM days worn | During the intervention | Number of days that the subjects wear the CGM |
| CGM percentage of time active | During the intervention | Percentage of time that the CGM is active |
Countries
Denmark
Outcome results
None listed