Type 1 Diabetes MellitusCHILDNCT02137031
Continuous Glucose Monitoring and Metabolic Control in Children With Type 1 Diabetes
A study testing Mini Link REAL-Time Transmitter in people with Type 1 Diabetes Mellitus, run by University of Toronto at 2 sites in Canada.
Trial summary
The primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Mini Link REAL-Time Transmitter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2012to Apr 2014
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children aged 6-18 years
- T1D for greater than one year;
- Willing to perform at least three self-monitoring blood glucose tests per day;
- Has been using continuous subcutaneous insulin infusion for more than one month
- English speaking
Who cannot join
- Presence of celiac disease (can cause malabsorption of nutrients affecting metabolic control)
- Use of corticosteroids that have systemic effects and affect glucose levels
- Currently using continuous glucose monitoring
- Cognitively unable to self-manage, based on parent's and/or care provider's opinion
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Charles H. Best Centre
Whitby, Ontario, L1M 1Z5
About this study
Official title: Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management
The primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine participants' satisfaction with allocated treatment.
With increased and immediate information related to current and future (trend) glucose information provided by the continuous glucose monitor, children can then act upon this knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c levels.
Research on the effectiveness of continuous glucose monitoring on metabolic control in children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore, a pilot clinical trial will be designed to provide preliminary indicators of the feasibility and acceptability of continuous glucose monitoring on metabolic control and address the following objectives.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Mini Link REAL-Time Transmitter
- 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.
Mini Link REAL-Time TransmitterDevice
Children used the Mini Link REAL-Time Transmitter to measure glucose continuously for a minimum of three days per week for three months.
| Study group | Role | What they receive |
|---|---|---|
| Mini Link REAL-Time Transmitter | Experimental | Not described Receives: Device: Mini Link REAL-Time Transmitter |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Metabolic control as measured by standard HbA1c
Measured: 3 months
Secondary outcomes (4)
Fear of Hypoglycemia
Fear of Hypoglycemia as measured by Children's Hypoglycemia Index
Measured: 3 months
Frequency of Hypoglycemia
The number of hypoglycemic episodes experienced per person over three months
Measured: 3 months
Frequency of Hyperglycemia
Number of hyperglycemic episodes per person over the course of 3 months
Measured: 3 months
Frequency of Diabetic Ketoacidosis
Frequency of Diabetic Ketoacidosis episodes per person over the course of 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystie Robinson-Vincent, University of Toronto
- Investigators
- Krystie A Robinson-Vincent, PhD c, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137031
- Sponsor's protocol ID
- 27225
- Acronym
- CHILD
- Status last verified
- May 2014
- First submitted
- 7 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management
- ClinicalTrials.gov ID
- NCT02137031
- Acronym / sponsor ID
- CHILD / 27225
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 May 2014 (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 primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine participants' satisfaction with allocated treatment.
With increased and immediate information related to current and future (trend) glucose information provided by the continuous glucose monitor, children can then act upon this knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c levels.
Research on the effectiveness of continuous glucose monitoring on metabolic control in children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore, a pilot clinical trial will be designed to provide preliminary indicators of the feasibility and acceptability of continuous glucose monitoring on metabolic control and address the following objectives.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mini Link REAL-Time Transmitter | Experimental | Device: Mini Link REAL-Time Transmitter |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children aged 6-18 years
- T1D for greater than one year;
- Willing to perform at least three self-monitoring blood glucose tests per day;
- Has been using continuous subcutaneous insulin infusion for more than one month
- English speaking
Key exclusion criteria (4 listed)
- Presence of celiac disease (can cause malabsorption of nutrients affecting metabolic control)
- Use of corticosteroids that have systemic effects and affect glucose levels
- Currently using continuous glucose monitoring
- Cognitively unable to self-manage, based on parent's and/or care provider's opinion
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 |
|---|---|---|
| Mini Link REAL-Time TransmitterChildren used the Mini Link REAL-Time Transmitter to measure glucose continuously for a minimum of three days per week for three months. | Device | Mini Link REAL-Time Transmitter |
Primary outcome
HbA1c
Time frame: 3 months
Metabolic control as measured by standard HbA1c
4 secondary outcomes
Fear of Hypoglycemia
Time frame: 3 months
Frequency of Hypoglycemia
Time frame: 3 months
Frequency of Hyperglycemia
Time frame: 3 months
Frequency of Diabetic Ketoacidosis
Time frame: 3 months
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 13 May 2014.
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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.
Krystie A Robinson-Vincent, PhD c principal investigator
University of Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Link REAL-Time Transmitter in people with Type 1 Diabetes Mellitus, run by University of Toronto at 2 sites in Canada.
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 5 inclusion and 4 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 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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?
HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2014.