Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections
Long-term Effects of Continuous Glucose Monitoring in Patients With Type 1 Diabetes Treated With Multiple Daily Insulin Injections - Extension of CGMMDI Trial
1 other identifier
interventional
100
1 country
15
Brief Summary
A keystone in preventing diabetic complications in patients with type 1 diabetes is good glycaemic control. Frequent self-measurements of blood glucose (SMBG) levels have been an essential part of insulin dosing before meals. However, in recent years continuous glucose monitoring (CGM) has become a treatment option to inform the patient when glucose levels may be too high or low. In some countries, including Sweden, CGM is reimbursed only when combined with continuous subcutaneous insulin infusions (CSII) in patients with very poor glycaemic control or a history of repeated severe hypoglycaemia in adults with type 1 diabetes. This is based on existing clinical trial data showing a beneficial effect on HbA1c when CGM is combined with CSII. However, despite the fact that the majority of adults with type 1 diabetes are treated with multiple daily insulin injections (MDI), studies on the effect of CGM in patients with type 1 diabetes treated with MDI are sparse. Therefore, the investigators initiated the CGMMDI trial, an ongoing, cross-over clinical trial including 161 MDI patients receiving CGM over 6 months, followed by conventional therapy over six months, with a four-month wash-out period in-between treatment. Evaluations include glycaemic control, hypoglycaemia, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety. From a research or regulatory standpoint, long-term data on treatment effects are expected to a greater extent today than in previous years, due to various reasons, e.g., to evaluate any sustained beneficial effects over time, or long-term patient safety. Accordingly, follow-up of treatment in an extension phase after randomized diabetes trials have become more common over time, especially where many novel glucose-lowering treatments are concerned. Therefore, the aim of the current study is to evaluate long-term effects of CGM in patients with type 1 diabetes treated with MDI. Patients who consent in an extension phase over 1 year of the CGMMDI trial will receive CGM, and evaluations will be performed on sustained glycaemic control effects, hypoglycaemia, glycaemic variability, quality of life, fear of hypoglycaemia, treatment satisfaction, physical activity, and safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Typical duration for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedNovember 8, 2017
November 1, 2016
2 years
May 26, 2015
November 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c in venous sample
For all variables, measurement at the end of this extension of a cross-over study will be compared to the measurement before long-term CGM was initiated.
52 weeks or 78 weeks
Secondary Outcomes (15)
Mean glucose level measured by CGM during two weeks.
52 weeks/78 weeks
Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.
52 weeks/78 weeks
Standard deviation of glucose levels measured by CGM during two weeks.
52 weeks/78 weeks
Treatment satisfaction: DTSQs scores
52 weeks/78 weeks
Well being: WHO 5 scores
52 weeks/78 weeks
- +10 more secondary outcomes
Study Arms (1)
Long-term CGM
EXPERIMENTALContinuous glucose monitoring with DexCom G4 platina or later generations during 12 months following participation in the CGMMDI trial
Interventions
Continuous glucose monitoring with DexCom G4 platina or later generations
Eligibility Criteria
You may qualify if:
- Completion of the CGMMDI trial.
- Written informed consent.
You may not qualify if:
- Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months
- Required continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during CGM-use because it disturbs the interpretation of blood glucose levels estimated by the Dexcom. However, other pain killers can be used throughout the study duration.
- History of allergic reaction to any of the CGM materials or adhesives in contact with the skin, or to chlorhexidine or alcoholic anti-septic solution.
- Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- Other investigator-determined criteria making patients unsuitable for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vastra Gotaland Regionlead
- DexCom, Inc.collaborator
Study Sites (15)
Alingsås Hospital
Alingsås, Sweden
Angered Hospital
Angered, Sweden
Ängelholm Hospital
Ängelholm, Sweden
Öbackakliniken
Härnösand, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Central Hospital Kristianstad
Kristianstad, Sweden
Halland Hospital Kungsbacka
Kungsbacka, Sweden
Skåne University Hospital Malmö
Malmo, Sweden
Hospital in Motala
Motala, Sweden
Vrinnevi Hospital
Norrköping, Sweden
University Hospital Örebro
Örebro, Sweden
Södersjukhuset
Stockholm, Sweden
Hospital Trelleborg
Trelleborg, Sweden
NU Hospital Group
Uddevalla, Sweden
Academic Hospital Uppsala
Uppsala, Sweden
Related Publications (1)
Lind M, Olafsdottir AF, Hirsch IB, Bolinder J, Dahlqvist S, Pivodic A, Hellman J, Wijkman M, Schwarcz E, Albrektsson H, Heise T, Polonsky W. Sustained Intensive Treatment and Long-term Effects on HbA1c Reduction (SILVER Study) by CGM in People With Type 1 Diabetes Treated With MDI. Diabetes Care. 2021 Jan;44(1):141-149. doi: 10.2337/dc20-1468. Epub 2020 Nov 15.
PMID: 33199470DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Lind, MD, PhD
NU Hospital Group and University of Gothenburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 8, 2015
Study Start
June 1, 2015
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
November 8, 2017
Record last verified: 2016-11