Diabetes Mellitus, Insulin-DependentNCT00357890
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
A study testing Insulin pump therapy and Multiple daily injections using insulin glargine + rapid acting analog in people with Diabetes Mellitus, Insulin-Dependent, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- Insulin pump therapy and Multiple daily injections using insulin glargine + rapid acting analog
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patient between the age of 12 and 17 years inclusive at time of entry into study (i.e., after their 12th but before their 18th birthday)
- Type 1 diabetes mellitus for no more than 10 days
- pubertal (Tanner stage 2 or above)
- The patient and parents or guardians should be able to do simple math calculations (necessary for pump management)
- Parent or legal guardian must give signed informed consent
Who cannot join
- No other chronic medical conditions (well-controlled thyroid disease is OK, and mild asthma is OK if the patient is not on chronic inhaled or oral daily corticosteroids)
- Exceptional psychological stress, more than expected for circumstances of having the new diagnosis of diabetes
- Inability or unwillingness to comply with requirements of the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
Official title: A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents With Newly-diagnosed Type 1 Diabetes on Insulin Resistance, Beta-cell Function and the Honeymoon Period.
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).
Read the detailed description
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups. More importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes.
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Being tested
- Insulin pump therapy, Multiple daily injections using insulin glargine + rapid acting analog
- Keywords
- type 1 diabetes, diabetes, new onset, CSII, insulin sensitivity, beta cell function, beta cell preservation
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin pump therapyDevice
Also called Continuous subcutaneous insulin infusion (CSII)
CSII initiated within 1 month of diagnosis
Multiple daily injections using insulin glargine + rapid acting analogDrug
Also called MDI using glargine plus a rapid acting analog
MDI as control
| Study group | Role | What they receive |
|---|---|---|
| Pump therapy (CSII) | Experimental | Use of pump therapy Receives: Device: Insulin pump therapy |
| Multiple daily injections (MDI) | Active comparator | Use of MDI (basal bolus therapy with glargine) Receives: Drug: Multiple daily injections using insulin glargine + rapid acting analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.
Measured: 24 months
Beta Cell Function
Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing
Measured: 24 months
Secondary outcomes (2)
Hemoglobin A1c
Hemoglobin A1c (HbA1c) (%)
Measured: 24 months
Percent Body Fat
Percent body fat based on DEXA scan (%BF)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Insulin-DependentStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry A. Fox, MD, Nemours Children's Clinic
- Investigators
- Larry A Fox, MD, Principal investigator, Nemours Chidlren's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357890
- Sponsor's protocol ID
- 16-03890-002
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2006
- Last updated
- 7 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents With Newly-diagnosed Type 1 Diabetes on Insulin Resistance, Beta-cell Function and the Honeymoon Period.
- ClinicalTrials.gov ID
- NCT00357890
- Acronym / sponsor ID
- 16-03890-002
- Conditions
- Diabetes Mellitus, Insulin-Dependent
- Keywords
- type 1 diabetes, diabetes, new onset, CSII, insulin sensitivity, beta cell function, beta cell preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Jul 2006 (estimated)
- Results
- Posted 7 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).
Detailed description
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups. More importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pump therapy (CSII) | Experimental | Device: Insulin pump therapyUse of pump therapy |
| Multiple daily injections (MDI) | Active comparator | Drug: Multiple daily injections using insulin glargine + rapid acting analogUse of MDI (basal bolus therapy with glargine) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female patient between the age of 12 and 17 years inclusive at time of entry into study (i.e., after their 12th but before their 18th birthday)
- Type 1 diabetes mellitus for no more than 10 days
- pubertal (Tanner stage 2 or above)
- The patient and parents or guardians should be able to do simple math calculations (necessary for pump management)
- Parent or legal guardian must give signed informed consent
Key exclusion criteria (3 listed)
- No other chronic medical conditions (well-controlled thyroid disease is OK, and mild asthma is OK if the patient is not on chronic inhaled or oral daily corticosteroids)
- Exceptional psychological stress, more than expected for circumstances of having the new diagnosis of diabetes
- Inability or unwillingness to comply with requirements of the protocol
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 |
|---|---|---|
| Insulin pump therapyAlso: Continuous subcutaneous insulin infusion (CSII)CSII initiated within 1 month of diagnosis | Device | Pump therapy (CSII) |
| Multiple daily injections using insulin glargine + rapid acting analogAlso: MDI using glargine plus a rapid acting analogMDI as control | Drug | Multiple daily injections (MDI) |
Primary outcome
Insulin Sensitivity
Time frame: 24 months
Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.
Beta Cell Function
Time frame: 24 months
Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing
2 secondary outcomes
Hemoglobin A1c
Time frame: 24 months
Percent Body Fat
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Larry A Fox, MD principal investigator
Nemours Chidlren's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin pump therapy and Multiple daily injections using insulin glargine + rapid acting analog in people with Diabetes Mellitus, Insulin-Dependent, run by Nemours Children's Clinic at 1 site in United States.
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 3 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 7 Jul 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Sensitivity (time frame: 24 months). The study lists 2 primary outcomes in all. 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 7 Jul 2023.