A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care
Primary Purpose
Type1diabetes
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
systematic intensive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Type1diabetes
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
- Clinical diagnosis of Type 1 diabetes
- Adult patients over 18 years of age
- HbA1c ≥ 58 mmol/mol
- Currently using CGM or FGM
- To have a possibility to download and share FGM/CGM data
Exclusion Criteria:
- Type 2 diabetes
- Diabetes duration <1 year
- Long-term Systemic glucocorticoid treatment during the last 3 months
- Planned or changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
- Current or planned pregnancy or breastfeeding during the next 12 months
- Planned move during the next 12 months making it not possible to participate in study activities
- Other reason determined by the investigator not being appropriate for participation
Sites / Locations
- NU-Hosptial Group
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Normal diabetes care
Systematic intensive therapy
Arm Description
Continue with their normal diabetes care. Come in for control visits
Intensive Internet and telephone contact for 4 months and Control visits
Outcomes
Primary Outcome Measures
Change in HbA1c
Change in HbA1c from baseline to week 18 and week 52
Secondary Outcome Measures
Change in Time in Range and Time in Target
Change in Time in Range (4-10mmol/l) and Time in Target (4-8mmol/l) from Baseline to week 18 and week 52
Mean glucose levels
Change in mean glucose levels from baseline to 18 and 52 weeks
Glycaemic variability
Change in glycaemic variability from baseline to 18 and 52 weeks using Standard deviation, Coefficient of variation and MAGE
Hypoglycaemia
Change in time in hypoglycaemia from baseline to 18 and 52 weeks
Hyperglycaemia
Change in time in hyperglycaemia from baseline to 18 and 52 weeks
Hypoglycaemic confidence
Change in Hypoglycaemic confidence score from baseline to 18 and 52 weeks. The hypoglycemic confidence scale is a 4pt Lickert scale with 9 questions
DDS
Change in DDS score from baseline to 18 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions
DTSQ
Change in DTSQs score from baseline to 18, and 52 weeks and DTSQc at 18 and 52 weeks. the DTSQ is a 7 pt Lickert scale with 8 questions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03474393
Brief Title
A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care
Official Title
A Randomised Trial of Evaluating a Systematic Intensive Therapy Using Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) in Clinical Diabetes Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved HbA1c for persons with type 1 diabetes which are already treated with CGM or FGM, and if the effect continuous for 1-2 years after the intervention stops. Time in Hypoglycaemia, treatment satisfaction, Diabetes distress and hypoglycaemia fear will even be analysed.
A randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hbA1c ≥ 58mmol/mol and treated with CGM or FGM.
The control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
The intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. They will receive help with analysing data and advice on how to improve their glucose values. They will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for HbA1c and to fill in questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal diabetes care
Arm Type
No Intervention
Arm Description
Continue with their normal diabetes care. Come in for control visits
Arm Title
Systematic intensive therapy
Arm Type
Experimental
Arm Description
Intensive Internet and telephone contact for 4 months and Control visits
Intervention Type
Other
Intervention Name(s)
systematic intensive therapy
Intervention Description
intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change in HbA1c from baseline to week 18 and week 52
Time Frame
from baseline to 52 weeks
Secondary Outcome Measure Information:
Title
Change in Time in Range and Time in Target
Description
Change in Time in Range (4-10mmol/l) and Time in Target (4-8mmol/l) from Baseline to week 18 and week 52
Time Frame
from baseline to 52 weeks
Title
Mean glucose levels
Description
Change in mean glucose levels from baseline to 18 and 52 weeks
Time Frame
from baseline to 52 weeks
Title
Glycaemic variability
Description
Change in glycaemic variability from baseline to 18 and 52 weeks using Standard deviation, Coefficient of variation and MAGE
Time Frame
from baseline to 52 weeks
Title
Hypoglycaemia
Description
Change in time in hypoglycaemia from baseline to 18 and 52 weeks
Time Frame
from baseline to 52 weeks
Title
Hyperglycaemia
Description
Change in time in hyperglycaemia from baseline to 18 and 52 weeks
Time Frame
from baseline to 52 weeks
Title
Hypoglycaemic confidence
Description
Change in Hypoglycaemic confidence score from baseline to 18 and 52 weeks. The hypoglycemic confidence scale is a 4pt Lickert scale with 9 questions
Time Frame
from baseline to 52 weeks
Title
DDS
Description
Change in DDS score from baseline to 18 and 52 weeks. DDS is a 6 pt Lickert scale with 28 questions
Time Frame
from baseline to 52 weeks
Title
DTSQ
Description
Change in DTSQs score from baseline to 18, and 52 weeks and DTSQc at 18 and 52 weeks. the DTSQ is a 7 pt Lickert scale with 8 questions.
Time Frame
from baseline to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management)
Clinical diagnosis of Type 1 diabetes
Adult patients over 18 years of age
HbA1c ≥ 58 mmol/mol
Currently using CGM or FGM
To have a possibility to download and share FGM/CGM data
Exclusion Criteria:
Type 2 diabetes
Diabetes duration <1 year
Long-term Systemic glucocorticoid treatment during the last 3 months
Planned or changed treatment the last 3 months regarding MDI vs. Insulin pump or added or stopped CGM or FGM therapy
Current or planned pregnancy or breastfeeding during the next 12 months
Planned move during the next 12 months making it not possible to participate in study activities
Other reason determined by the investigator not being appropriate for participation
Facility Information:
Facility Name
NU-Hosptial Group
City
Uddevalla
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Evaluation of Systematic Intensive Therapy Using CGM/FGM in Clinical Diabetes Care
We'll reach out to this number within 24 hrs