Diabetes Self-management With Continuous Glucose Monitoring

Not yet recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06453434
• Lead Sponsor: Nordsjaellands Hospital

Brief 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

Detailed 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)

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-05
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Start: 2024-07-01
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diabetes Distress	At baseline and after 14 days.	Type 1 Diabetes Distress Scale (T1-DDS-28)) Score. Likert scale. Score from 1 to 5. Higher scores indicate higher grade of diabetes distress.

Secondary Outcome Measures

Name	Time	Method
Time below range level 1 (TBR1)	14 days	The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL)
TBR2 night	14 days	TBR \<3.0 from 0000h to 0559h, level 2 night
TBR2 day	14 days	TBR \<3.0 from 0600h to 2359h, level 2 day
TAR1 night	14 days	TAR1 10.1-13.9 from 0000h to 0559h, level 1 night
Standard deviation of mean glucose (SD)	14 days	Standard deviation of mean glucose (SD) (mmol/L and mg/dL)
Time in tight range (TIR)	14 days	The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL)
Time below range level 2 (TBR2)	14 days	The percentage of time the sensor glucose is \<3.0 mmol/L (\<54 mg/dL)
TAR1 day	14 days	TAR1 10.1-13.9 from 0600h to 2359h, level 1 day
TAR2 night	14 days	TAR2 \>13.9 from 0000h to 0559h, level 1 night
Time above range level 2 (TAR2)	14 days	The percentage of time the sensor glucose is 13.9 mmol/L (\>250 mg/dL)
TAR2 day	14 days	TAR2 \>13.9 from 0600h to 2359h, level 1 day
Coefficient of variation (CV)	14 days	Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose)
Mean sensor glucose	14 days	Mean sensor glucose (mmol/L and mg/dL)
Time in range (TIR)	14 days	Time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL)
TBR1 night	14 days	TBR 3.0-3.9 from 0000h to 0559h, level 1 night
TBR1 day	14 days	TBR 3.0-3.9 from 0600h to 2359h, level 1 day
Time above range level 1 (TAR1)	14 days	The percentage of time the sensor glucose is 10.1-13.9 mmol/L (181-250 mg/dL)

Trial Locations

Locations (2)

Steno Diabetes Center Copenhagen; 🇩🇰 Herlev, Region Hovedstaden, Denmark

Copenhagen University Hospital, North Zealand - Hilleroed; 🇩🇰 Hillerød, Region Hovedstaden, Denmark