Diabetes MellitusktpumpNCT00574405
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
A study testing MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) and CSII (Animas Corporation insulin pump, model IR 1200) in people with Diabetes Mellitus, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) and CSII (Animas Corporation insulin pump, model IR 1200)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Mar 2011
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Medical history and clinical presentation consistent with the diagnosis of Type 1 DM.
- Age: 8-18 years
Who cannot join
- Clinical presentation consistent with Type 2 DM.
- History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions.
- Concurrent pregnancy.
- Participation in other research protocols or use of other investigational agents within 30 days of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital/Research Institute
Little Rock, Arkansas, 72202
About this study
Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.
- Conditions
- Diabetes Mellitus
- Being tested
- MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]), CSII (Animas Corporation insulin pump, model IR 1200)
- Keywords
- Insulin pump, Beta cell
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])Drug
Also called Novolog® or Humalog®
MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
CSII (Animas Corporation insulin pump, model IR 1200)Device
Also called Animas Corporation insulin pump, model IR 1200
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®). Receives: Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) |
| 2 | Experimental | CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200. Receives: Device: CSII (Animas Corporation insulin pump, model IR 1200) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
Measured: 12 months
Secondary outcomes (4)
Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.
Measured: 12 months
Changes in Daily Insulin Requirements Over Time
Measured: 12 months
Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.
Measured: 12 months
Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startApr 2005
- Primary completionMar 2010
- Study completionMar 2011
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 MellitusStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn M Thrailkill, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574405
- Sponsor's protocol ID
- 29256
- Other IDs
- CUMG - 090104KT
- Acronym
- ktpump
- Status last verified
- Sep 2017
- First submitted
- 12 Dec 2007
- Last updated
- 13 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
- ClinicalTrials.gov ID
- NCT00574405
- Acronym / sponsor ID
- ktpump / 29256
- Conditions
- Diabetes Mellitus
- Keywords
- Insulin pump, Beta cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Posted 9 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®). |
| 2 | Experimental | Device: CSII (Animas Corporation insulin pump, model IR 1200)CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Medical history and clinical presentation consistent with the diagnosis of Type 1 DM.
- Age: 8-18 years
Key exclusion criteria (4 listed)
- Clinical presentation consistent with Type 2 DM.
- History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions.
- Concurrent pregnancy.
- Participation in other research protocols or use of other investigational agents within 30 days of enrollment.
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 |
|---|---|---|
| MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])Also: Novolog® or Humalog®MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration. | Drug | 1 |
| CSII (Animas Corporation insulin pump, model IR 1200)Also: Animas Corporation insulin pump, model IR 1200CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200. | Device | 2 |
Primary outcome
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI.
Time frame: 12 months
4 secondary outcomes
Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment.
Time frame: 12 months
Changes in Daily Insulin Requirements Over Time
Time frame: 12 months
Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.
Time frame: 12 months
Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- 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.
Kathryn M Thrailkill, MD principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) and CSII (Animas Corporation insulin pump, model IR 1200) in people with Diabetes Mellitus, run by Arkansas Children's Hospital Research Institute 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 2 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 Sep 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 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 9 Aug 2011). 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?
Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. (time frame: 12 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 Sep 2017.