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| Name | Class |
|---|---|
| Steno Diabetes Center Sjaelland | OTHER_GOV |
| Novo Nordisk A/S | INDUSTRY |
| Glooko | INDUSTRY |
| DexCom, Inc. |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Device | Telemonitoring of CGM and insulin pen data |
|
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36476605 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| INDUSTRY |
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| 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 |
| 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 |
| D006946 | Hyperinsulinism |