Long Term CGM Treatment in Patients With Type 1 Diabetes Treated With Insulin Injections

Diabetes Mellitus Type 1 Clinical Trial

Official title:

Long-term Effects of Continuous Glucose Monitoring in Patients With Type 1 Diabetes Treated With Multiple Daily Insulin Injections - Extension of CGMMDI Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465411
• Other study ID #: CGMMDI Extension
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: November 7, 2017
• Start date: June 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: November 2016
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completion of the CGMMDI trial.

• Written informed consent.

Exclusion Criteria:

• Pregnancy, planned pregnancy for the study duration or pregnancy during the last six months

• Severe cognitive dysfunction or other disease, which is adjudicated by a physician as not suitable for inclusion.

• 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Dexcom G4 or later generation
Continuous glucose monitoring with DexCom G4 platina or later generations

Locations

Country	Name	City	State
Sweden	Alingsås Hospital	Alingsås
Sweden	Ängelholm Hospital	Ängelholm
Sweden	Angered Hospital	Angered
Sweden	Öbackakliniken	Härnösand
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Central Hospital Kristianstad	Kristianstad
Sweden	Halland Hospital Kungsbacka	Kungsbacka
Sweden	Skåne University Hospital Malmö	Malmö
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

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	DexCom, Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean glucose level measured by CGM during two weeks.		52 weeks/78 weeks
Secondary	Mean Amplitude of Glycemic Excursions (MAGE) measured by CGM during two weeks.		52 weeks/78 weeks
Secondary	Standard deviation of glucose levels measured by CGM during two weeks.		52 weeks/78 weeks
Secondary	Treatment satisfaction: DTSQs scores	Diabetes Treatment Satisfaction Questionnaire (Status)	52 weeks/78 weeks
Secondary	Well being: WHO 5 scores	Questionnaire	52 weeks/78 weeks
Secondary	Hypoglycemia fear: SWE-HFS scores	Swedish Hypoglycaemia Fear Scale Questionnaire	52 weeks/78 weeks
Secondary	Problem areas: SWE-PAID-20 scores	Swedish Problem Areas In Diabetes Questionnaire	52 weeks/78 weeks
Secondary	Physical activity: IPAQ score	International Physical Activity Questionnaire	52 weeks/78 weeks
Secondary	Treatment experience of CGM score	Questionnaire developed for this trial	52 weeks/78 weeks
Secondary	Proportion of time with low glucose levels measured by CGM during two weeks.	Below 3.0 mmol/l and below 4.0 mmol/l, respectively.	52 weeks/78 weeks
Secondary	Proportion of time with high glucose levels measured by CGM during two weeks.	Above 10.0 mmol/l and above 13.9 mmol/l, respectively.	52 weeks/78 weeks
Secondary	Proportion of time with euglycaemic levels measured by CGM during two weeks.	5.5-10.0 mmol/l and 3.9-10.0 mmol/l, respectively.	52 weeks/78 weeks
Secondary	Proportion of patients lowering their HbA1c by 5 mmol/mol (0.5% in DCCT) or more.		52 weeks/78 weeks
Secondary	Proportion of patients lowering their HbA1c 10 mmol/mol (1% in DCCT) or more		52 weeks/78 weeks
Secondary	Number of self-reported severe hypoglycaemic events per year	Defined as unconsciousness due to hypoglycaemia or need for assistance from another person to resolve hypoglycaemia.	52 weeks/78 weeks