Diabetes Self-management With Continuous Glucose Monitoring

ConditionType 1 Diabetes

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-85

SponsorNordsjaellands Hospital

About this trial

The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics.

Participants will:

* Visit the clinic twice with a 14-day interval * Fill out a survey before the first and at the last visit * Use CGM as usual and use smart insulin pens and an activity tracker * Register food intake * Answer two-three questions twice a day in REDCap

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 85 years.

Diagnosed with T1D over one year ago.

Actively using FreeStyle Libre 2 (>80% sensor activity).

Used FreeStyle Libre 2 for over three months.

Disqualifiers

History of allergic reactions to materials or adhesives used in CGM devices.

Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.

Current use of steroids unless part of a chronic therapy plan.

Daily consumption of vitamin C ≥ 500 mg.

Trial population

Adults with type 1 diabetes (n=500) on multiple daily insulin injections already using FreeStyle Libre 2.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

Diabetes Distress

Type 1 Diabetes Distress Scale (T1-DDS-28)) Score. Likert scale. Score from 1 to 5. Higher scores indicate higher grade of diabetes distress.

Time frame

At baseline and after 14 days.

Secondary outcomes

Time in range (TIR)

Time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL)

Time frame

14 days

Time in tight range (TIR)

The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL)

Time frame

14 days

Time below range level 1 (TBR1)

The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL)

Time frame

14 days

Time below range level 2 (TBR2)

The percentage of time the sensor glucose is \<3.0 mmol/L (\<54 mg/dL)

Time frame

14 days

Other outcomes

Frequency of daily CGM readings

How many times the participants open the LibreView app to assess their CGM data during the day

Time frame

14 days

Diurnal variation of daily CGM readings

Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), in the evening (18.00-23.59) and in the night (00.00-05.59)

Time frame

14 days

Active sensor

Percentage of sensor data obtained

Time frame

14 days

Frequency of daily between-meal insulin corrections

How many times the participants take between-meal insulin corrections daily

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nordsjaellands Hospital

Lead sponsor

Steno Diabetes Center Copenhagen

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: