Type 1 Diabetes MellitusINCONTROLNCT01787903
The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA
A study testing Real-time continuous glucose monitor in people with Type 1 Diabetes Mellitus and Hypoglycemia Unawareness, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Hypoglycemia Unawareness
- What is being tested?
- Real-time continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1DM, diagnosed according to ADA criteria regardless duration
- Use of multiple daily injections of insulin (with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion
- Any HbA1c
- Age between 18 and 70 years old (inclusive)
- IHA according to the questionnaire by Gold et al.
- Performing at least 3 SMBG/day or 21 SMBG/week
Who cannot join
- Type 2 diabetes mellitus
- History of (recent) major renal, liver, or (ischemic) heart disease (including cardiac conduction disorders)
- Current untreated proliferative diabetic retinopathy
- Current (treatment for) malignancy
- Current use of non-selective beta-blockers
- Current psychiatric disorders, including schizophrenia, bipolar disorder, anorexia nervosa or bulimia nervosa
Show all 13Show fewer
- Substance abuse or alcohol abuse (men >21 units/week, women >14 units/week)
- Current pregnancy or intention to conceive
- Current use of RT-CGM other than for short term (i.e. diagnostic use or use shorter than 3 consecutive months)
- Hearing or vision impairment hindering perceiving of glucose display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion of the investigator
- Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding of the purpose and instructions of the study
- Participation in another clinical study
- Known or suspected allergy to trial product or related products
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081
About this study
Official title: The Effects of Real-time Continuous Glucose Monitoring on Glycemia and Quality of Life in Patients With Type 1 Diabetes Mellitus and Impaired Hypoglycemia Awareness
The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness.
Read the detailed description
The investigators hypothesize that the use of RT-CGM, relative to a control intervention using masked CGM, will result in improvement of various measures of glycemia and indicators of quality of life, reduce the occurrence of hypoglycemia and hyperglycemia and restore hypoglycemia awareness in T1DM patients with IHA. We will test this hypothesis by addressing the following research questions:
What is the effect of 16 weeks of RT-CGM use, versus 16 weeks of CGM use, in patients with T1DM and IHA on
- (primary objective:) time spent in euglycemia
- (secondary objectives:)
- (diabetes-specific) markers of QoL, covering diabetes-related emotional distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5)
- other glycemia variables, including HbA1c and time spent in hypo- and - hyperglycemia ranges
- the incidence and duration of hypoglycemic episodes
- changes in hypoglycemia awareness score according to Gold et al.,
- (tertiary objectives:)
- measures of glucose variability
- the autonomic nervous system balance
- the duration of wear of the RT-CGM device
- patients' therapy adjustments during the interventions
- hypoglycemia awareness scores according to Clarke et al.
- satisfaction with use of CGM
- the number of contact moments not planned according to the study schedule
- absence of work of patient (and spouse)
- the global estimated costs of use of health care
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia Unawareness
- Being tested
- Real-time continuous glucose monitor
- Keywords
- Type 1 diabetes mellitus, Hypoglycemia unawareness, Real-time continuous glucose monitoring, Glucose control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time continuous glucose monitorDevice
Also called MiniMed Paradigm® Veo™-system, iPro™2 Continuous Glucose Monitor
Active Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)
| Study group | Role | What they receive |
|---|---|---|
| Real-time continuous glucose monitor | Active comparator | 16 weeks use of a real-time continuous glucose monitor Receives: Device: Real-time continuous glucose monitor |
| Continuous glucose monitor | Placebo comparator | 16 weeks use of a (blinded, retrospective) continuous glucose monitor Receives: Device: Real-time continuous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in the euglycemic range
The mean difference in time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), expressed as hours/day between the two 16-week intervention periods, i.e. RT-CGM versus masked CGM in patients with T1DM and IHA.
Measured: 45 weeks
Secondary outcomes (4)
Quality of life
(diabetes-specific) markers of QoL, covering diabetes-related emotional distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5)
Measured: 45 weeks
Glycemia variables
Other glycemia variables, including HbA1c and time spent in hypo- and hyperglycemia ranges
Measured: 45 weeks
Hypoglycemic episodes
The incidence and duration of hypoglycemic episodes
Measured: 45 weeks
Changes in hypoglycemia awareness score
Changes in hypoglycemia awareness score according to Gold et al.
Measured: 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Erik Serne, Amsterdam UMC, location VUmc
- Investigators
- Erik H Serné, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787903
- Sponsor's protocol ID
- DC2012INCONTROL01
- Acronym
- INCONTROL
- Status last verified
- Jul 2017
- First submitted
- 6 Feb 2013
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
van Beers CA, DeVries JH, Kleijer SJ, Smits MM, Geelhoed-Duijvestijn PH, Kramer MH, Diamant M, Snoek FJ, Serne EH. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016 Nov;4(11):893-902. doi: 10.1016/S2213-8587(16)30193-0. Epub 2016 Sep 15.
PubMed 27641781van Beers CA, Kleijer SJ, Serne EH, Geelhoed-Duijvestijn PH, Snoek FJ, Kramer MH, Diamant M. Design and rationale of the IN CONTROL trial: the effects of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired awareness of hypoglycemia. BMC Endocr Disord. 2015 Aug 21;15:42. doi: 10.1186/s12902-015-0040-3.
PubMed 26292721
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Real-time Continuous Glucose Monitoring on Glycemia and Quality of Life in Patients With Type 1 Diabetes Mellitus and Impaired Hypoglycemia Awareness
- ClinicalTrials.gov ID
- NCT01787903
- Acronym / sponsor ID
- INCONTROL / DC2012INCONTROL01
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia Unawareness
- Keywords
- Type 1 diabetes mellitus, Hypoglycemia unawareness, Real-time continuous glucose monitoring, Glucose control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Feb 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness.
Detailed description
The investigators hypothesize that the use of RT-CGM, relative to a control intervention using masked CGM, will result in improvement of various measures of glycemia and indicators of quality of life, reduce the occurrence of hypoglycemia and hyperglycemia and restore hypoglycemia awareness in T1DM patients with IHA. We will test this hypothesis by addressing the following research questions:
What is the effect of 16 weeks of RT-CGM use, versus 16 weeks of CGM use, in patients with T1DM and IHA on
- (primary objective:) time spent in euglycemia
- (secondary objectives:)
- (diabetes-specific) markers of QoL, covering diabetes-related emotional distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5)
- other glycemia variables, including HbA1c and time spent in hypo- and - hyperglycemia ranges
- the incidence and duration of hypoglycemic episodes
- changes in hypoglycemia awareness score according to Gold et al.,
- (tertiary objectives:)
- measures of glucose variability
- the autonomic nervous system balance
- the duration of wear of the RT-CGM device
- patients' therapy adjustments during the interventions
- hypoglycemia awareness scores according to Clarke et al.
- satisfaction with use of CGM
- the number of contact moments not planned according to the study schedule
- absence of work of patient (and spouse)
- the global estimated costs of use of health care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time continuous glucose monitor | Active comparator | Device: Real-time continuous glucose monitor16 weeks use of a real-time continuous glucose monitor |
| Continuous glucose monitor | Placebo comparator | Device: Real-time continuous glucose monitor16 weeks use of a (blinded, retrospective) continuous glucose monitor |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- T1DM, diagnosed according to ADA criteria regardless duration
- Use of multiple daily injections of insulin (with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion
- Any HbA1c
- Age between 18 and 70 years old (inclusive)
- IHA according to the questionnaire by Gold et al.
Key exclusion criteria (13 listed)
- Type 2 diabetes mellitus
- History of (recent) major renal, liver, or (ischemic) heart disease (including cardiac conduction disorders)
- Current untreated proliferative diabetic retinopathy
- Current (treatment for) malignancy
- Current use of non-selective beta-blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time continuous glucose monitorAlso: MiniMed Paradigm® Veo™-system, iPro™2 Continuous Glucose MonitorActive Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked) | Device | Continuous glucose monitor, Real-time continuous glucose monitor |
Primary outcome
Time spent in the euglycemic range
Time frame: 45 weeks
The mean difference in time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), expressed as hours/day between the two 16-week intervention periods, i.e. RT-CGM versus masked CGM in patients with T1DM and IHA.
4 secondary outcomes
Quality of life
Time frame: 45 weeks
Glycemia variables
Time frame: 45 weeks
Hypoglycemic episodes
Time frame: 45 weeks
Changes in hypoglycemia awareness score
Time frame: 45 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Derived from this study: PubMed 27641781van Beers CA, DeVries JH, Kleijer SJ, Smits MM, Geelhoed-Duijvestijn PH, Kramer MH, Diamant M, Snoek FJ, Serne EH. Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial. Lancet Diabetes Endocrinol. 2016 Nov;4(11):893-902. doi: 10.1016/S2213-8587(16)30193-0. Epub 2016 Sep 15.
- Derived from this study: PubMed 26292721van Beers CA, Kleijer SJ, Serne EH, Geelhoed-Duijvestijn PH, Snoek FJ, Kramer MH, Diamant M. Design and rationale of the IN CONTROL trial: the effects of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired awareness of hypoglycemia. BMC Endocr Disord. 2015 Aug 21;15:42. doi: 10.1186/s12902-015-0040-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik H Serné, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time continuous glucose monitor in people with Type 1 Diabetes Mellitus and Hypoglycemia Unawareness, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in the euglycemic range (time frame: 45 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787903, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.