Diabetes Self-management With Continuous Glucose Monitoring

Type 1 Diabetes Clinical Trial

— DIASELF  

Official title:

The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453434
• Other study ID #: U1111-1306-6133
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Nordsjaellands Hospital
• Contact: Mette J Nitschke, PhD Student
• Phone: +45 41 24 72 16
• Email: mette.juul.nitschke[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

A two-centre observational study conducted in Denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using FreeStyle Libre 2. Upon recruitment, participants will complete a survey of 11 validated questionnaires, including T1-DDS-28. For 14 days, participants will continue regular CGM use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor physical activity and sleep. Participants will register food intake in the LibreLink app and respond to queries on quality of life twice daily through REDCap. At the end of the study, participants will complete the T1-DDS-28 and Health Literacy Questionnaire. Our primary objectives is to investigate the association between diabetes distress (assessed by Type 1 Diabetes Distress Scale (T1-DDS-28)) and: 1. frequency of reading CGM data, 2. frequency of low glucose alarms, 3. frequency of high glucose alarms, 4. frequency of daily between-meal insulin corrections, 5. frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin, 6. frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates, and 7. sociodemographic and psychosocial characteristics of CGM users. Our secondary objective is to investigate the association between glycaemic metrics and the variables described above. Glycaemic metrics will be reported as CGM-metrics, including time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL), per international consensus (ATTD, 2022)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 85 years.

2. Diagnosed with T1D over one year ago.

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

4. Used FreeStyle Libre 2 for over three months.

5. Uses multiple daily insulin injections.

6. Capable of providing written informed consent.

7. Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.

Exclusion Criteria:

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

2. 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.

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

4. Daily consumption of vitamin C = 500 mg.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev	Region Hovedstaden
Denmark	Copenhagen University Hospital, North Zealand - Hilleroed	Hillerød	Region Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of daily CGM readings	How many times the participants open the LibreView app to assess their CGM data during the day	14 days
Other	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)	14 days
Other	Active sensor	Percentage of sensor data obtained	14 days
Other	Frequency of daily between-meal insulin corrections	How many times the participants take between-meal insulin corrections daily	14 days
Other	Frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin,	For each hypoglycaemic event (defined as a glucose level = 10 mmol/L (180 mg/dL)) a cause of the event will be interpreted based on 4-hours data and classified as either preceded by 1) premeal-insulin, 2) insulin correction of hyperglycemia or 3) physical activity	14 days
Other	Frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates	For each hyperglycaemic event (defined as glucose level = 10 mmol/L (180 mg/dL) = 15 consecutive minutes) a cause of the event will be interpreted based on 4-hours data and classified as either preceded by 1) carbohydrate intake without premeal insulin, 2) carbohydrate intake with premeal insulin, or 3) correction of hypoglycaemia with carbohydrate	14 days
Other	High glucose alarm threshold	Mean/median alarm threshold level at baseline	At baseline
Other	Low glucose alarm threshold	Mean/median alarm threshold level at baseline	At baseline
Other	Frequency of high glucose alarms	Number of high glucose alarms during the study	14 days
Other	Frequency of low glucose alarms	Number of low glucose alarms during the study	14 days
Other	Low alarms enabled	Percentage of time low alarms are activated	14 days
Other	High alarms enabled	Percentage of time high alarms are activated	14 days
Other	Diurnal variation of high alarms	Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), evening (18.00-23.59) and night (00.00-05.59)	14 days
Other	Diurnal variation of low alarms	Numbers in the morning (06.00-11.59), afternoon (12.00-17.59), evening (18.00-23.59) and night (00.00-05.59)	14 days
Other	Smart pen engagement	Number of days with data uploads during the study period	14 days
Other	Total daily dose (TDD) of insulin	Mean of the study period. Recorded by smartpens.	14 days
Other	Total daily dose (TDD) of basal insulin	Mean of the study period. Recorded by smartpens.	14 days
Other	Total daily dose (TDD) of insulin delivered as premeal boluses	Mean of the study period. Recorded by smartpens.	14 days
Other	Total daily dose (TDD) of insulin delivered as correctional boluses	Mean of the study period. Recorded by smartpens.	14 days
Other	Percentage of TDD of insulin delivered as correctional boluses out of TDD of insulin	Percentage	14 days
Other	Missing basal insulin dose	= 40 hours between basal insulin injections	14 days
Other	Missing meal boluses	No bolus injection within 15 minutes before and 60 minutes after the start of a meal. Meals identified using a food diary/CGM signal by using the GRID algorithm.	14 days
Other	Diurnal variation of correctional boluses	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), respectively	14 days
Other	Step count per day	From activity sensor	14 days
Other	Moderate and vigorous physical activity (MVPA)	From activity sensor. Time spent on moderate and vigorous physical activity (MVPA)	14 days
Other	Low-intensity physical activity (LPA)	From activity sensor. Time spent on low-intensity physical activity (LPA) time	14 days
Other	Total physical activity (TPA) level	From activity sensor. TPA measured in counts per minute	14 days
Other	Sleep	From activity sensor. Sleep hours per night	14 days
Other	Food intake	Database which contains food intake data (amount of food in carbohydrates) retrieved from the diary app (LibreLink).	14 days
Other	Food intake	Database which contains food intake data (timing of food intake) retrieved from the diary app (LibreLink).	14 days
Other	Clarke score	Patient-reported outcome regarding awareness of hypoglycemia.	At baseline
Other	Gold score	Patient-reported outcome regarding awareness of hypoglycemia.	At baseline
Other	Hilleroed method	Patient-reported outcome regarding awareness of hypoglycemia.	At baseline
Other	Glucose Monitoring Satisfaction Survey (GMSS)	Patient-reported outcome regarding CGM satisfaction	At baseline
Other	Perceived Competence in Diabetes (PCD)	Patient-reported outcome regarding diabetes self-management	At baseline
Other	Diabetes Treatment Satisfaction Questionnaire status (DTSQs)	Patient-reported outcome regarding diabetes treatment satisfaction	At baseline
Other	Hypoglycaemia Fear Survey-II Short Form (HFS-SF)	Patient-reported outcome regarding fear of hypoglycemia	At baseline
Other	The Danish Health Literacy Questionnaire (HLQ)	Patient-reported outcome regarding health literacy	At baseline
Other	Based on Saltin-Grimby Physical Activity Level Scale (SGPALS)	Patient-reported outcome regarding physical activity	At baseline
Other	Well-Being Index (WHO-5)	Patient-reported outcome regarding psychological well-being	At baseline
Other	Pittsburgh Sleep Quality Index (PSQI)	Patient-reported outcome regarding sleep quality	At baseline
Other	Type D scale (DS-14)	Patient-reported outcome regarding type D personality trait	At baseline
Other	VAS-A	Patient-reported outcome regarding anxiety	Each morning and each evening during the study period
Other	EQ-VAS	Patient-reported outcome regarding overall health	Each morning during the study period
Primary	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.	At baseline and after 14 days.
Secondary	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)	14 days
Secondary	Time in tight range (TIR)	The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL)	14 days
Secondary	Time below range level 1 (TBR1)	The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL)	14 days
Secondary	Time below range level 2 (TBR2)	The percentage of time the sensor glucose is <3.0 mmol/L (<54 mg/dL)	14 days
Secondary	TBR1 night	TBR 3.0-3.9 from 0000h to 0559h, level 1 night	14 days
Secondary	TBR1 day	TBR 3.0-3.9 from 0600h to 2359h, level 1 day	14 days
Secondary	TBR2 night	TBR <3.0 from 0000h to 0559h, level 2 night	14 days
Secondary	TBR2 day	TBR <3.0 from 0600h to 2359h, level 2 day	14 days
Secondary	Time above range level 1 (TAR1)	The percentage of time the sensor glucose is 10.1-13.9 mmol/L (181-250 mg/dL)	14 days
Secondary	Time above range level 2 (TAR2)	The percentage of time the sensor glucose is 13.9 mmol/L (>250 mg/dL)	14 days
Secondary	TAR1 night	TAR1 10.1-13.9 from 0000h to 0559h, level 1 night	14 days
Secondary	TAR1 day	TAR1 10.1-13.9 from 0600h to 2359h, level 1 day	14 days
Secondary	TAR2 night	TAR2 >13.9 from 0000h to 0559h, level 1 night	14 days
Secondary	TAR2 day	TAR2 >13.9 from 0600h to 2359h, level 1 day	14 days
Secondary	Coefficient of variation (CV)	Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose)	14 days
Secondary	Mean sensor glucose	Mean sensor glucose (mmol/L and mg/dL)	14 days
Secondary	Standard deviation of mean glucose (SD)	Standard deviation of mean glucose (SD) (mmol/L and mg/dL)	14 days