Type 1 Diabetes MellitusDIDNCT00482443
Assessing the Effectiveness of Diabetes Interactive Diary (DID) in Diabetes Management
A study testing A software programme in mobile telephone and Standard Education Programme. in people with Type 1 Diabetes Mellitus, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial summary
For people with Type 1 Diabetes, blood glucose control is achieved by matching insulin doses directly to the amount of carbohydrate consumed. We are looking at new ways to help our patients with type 1 diabetes manage their diabetes control more effectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- A software programme in mobile telephone and Standard Education Programme.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to Apr 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or over
- Not habitually using carbohydrate counting and insulin dose adjustment
- Testing their blood sugar levels at least 3 times a day
- Using multiple daily injections of short-acting and long-acting insulin analogues
- With HbA1c between 7.5% and 10%
- Familiar with the use of mobile phones and possess a personal SIM card.
Who cannot join
- Mental conditions, depression or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Eating disorders
- Pregnancy
- Any clinically significant major organ system disease or infective diseases
- Any disease or condition or abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study procedures
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
About this study
Official title: A Multinational, Randomised Study of the Efficacy of the Diabetes Interactive Diary (DID), a Carbohydrates/Insulin Bolus Calculator and a Telemedicine System Based on the Communication Between Physician or Dietitian and Patient by SMS
For people with Type 1 Diabetes, blood glucose control is achieved by matching insulin doses directly to the amount of carbohydrate consumed. We are looking at new ways to help our patients with type 1 diabetes manage their diabetes control more effectively. We are testing if "Diabetes Interactive Diary" (DID), a novel programme designed to be used on a mobile phone, can represent an important tool in carbohydrate counting while avoiding the use of complex calculations and in depth knowledge about the carbohydrate content of their food.
Read the detailed description
This is randomized control trial aimed to evaluate the effectiveness of a DID compare to the standard education approach in order to help the patients with Type 1 diabetes to estimate the carbohydrate in their food and adjust insulin doses. It involves individuals with Type 1 diabetes who are not habitually using carbohydrate counting. They should be testing their blood sugar levels at least 3 times a day, using multiple daily injections of short-acting and long-acting insulin analogues, with HbA1c between 7.5% and 10% and are familiar with the use of mobile phones and possess a personal SIM card.
Patients will be randomized to the standard education programme run for 4 full days over a 4 week period or to the DID programme run as three 2-hour sessions over a two-week period.
The DID is a novel software programme installed on the patient's mobile telephone. It facilitates the communication between the dietitian and the patient by using SMS text messages, so that the dietitian can monitor glycaemic control and suggest adjustments if necessary. It can be described as a little computer, where the patient can record their blood glucose value, the amount of insulin injected and the amount of carbohydrate consumed.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- A software programme in mobile telephone, Standard Education Programme.
- 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.
A software programme in mobile telephoneOther
Use of Mobile phone technology in maintaining Diabetes Interactive Diary.
Standard Education Programme.Other
Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | To assess the efficacy of a Diabetes Interactive Diary in Diabetes Management. Receives: Other: A software programme in mobile telephone |
| 2 | Active comparator | Control Arm. Patients will receive standard education programme. Receives: Other: Standard Education Programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in HbA1c between the patient in the DID group and in the standard education group.
Measured: 6 month
Secondary outcomes (1)
The differences between the two groups in terms of, lipid profile, blood pressure, the number of hypoglycaemic episodes, daily blood sugar fluctuation, total insulin dose, weight changes and patients' satisfaction with the treatment.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionApr 2008
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Investigators
- David Kerr, Doctor, Principal investigator, Royal Bournemouth HospitalAnita Bowes, Dietitian, Principal investigator, Royal Bournemouth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482443
- Sponsor's protocol ID
- DID
- Acronym
- DID
- Status last verified
- Jul 2008
- First submitted
- 4 Jun 2007
- Last updated
- 10 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Randomised Study of the Efficacy of the Diabetes Interactive Diary (DID), a Carbohydrates/Insulin Bolus Calculator and a Telemedicine System Based on the Communication Between Physician or Dietitian and Patient by SMS
- ClinicalTrials.gov ID
- NCT00482443
- Acronym / sponsor ID
- DID / DID
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Jun 2007 (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.
For people with Type 1 Diabetes, blood glucose control is achieved by matching insulin doses directly to the amount of carbohydrate consumed. We are looking at new ways to help our patients with type 1 diabetes manage their diabetes control more effectively. We are testing if "Diabetes Interactive Diary" (DID), a novel programme designed to be used on a mobile phone, can represent an important tool in carbohydrate counting while avoiding the use of complex calculations and in depth knowledge about the carbohydrate content of their food.
Detailed description
This is randomized control trial aimed to evaluate the effectiveness of a DID compare to the standard education approach in order to help the patients with Type 1 diabetes to estimate the carbohydrate in their food and adjust insulin doses. It involves individuals with Type 1 diabetes who are not habitually using carbohydrate counting. They should be testing their blood sugar levels at least 3 times a day, using multiple daily injections of short-acting and long-acting insulin analogues, with HbA1c between 7.5% and 10% and are familiar with the use of mobile phones and possess a personal SIM card.
Patients will be randomized to the standard education programme run for 4 full days over a 4 week period or to the DID programme run as three 2-hour sessions over a two-week period.
The DID is a novel software programme installed on the patient's mobile telephone. It facilitates the communication between the dietitian and the patient by using SMS text messages, so that the dietitian can monitor glycaemic control and suggest adjustments if necessary. It can be described as a little computer, where the patient can record their blood glucose value, the amount of insulin injected and the amount of carbohydrate consumed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: A software programme in mobile telephoneTo assess the efficacy of a Diabetes Interactive Diary in Diabetes Management. |
| 2 | Active comparator | Other: Standard Education Programme.Control Arm. Patients will receive standard education programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 or over
- Not habitually using carbohydrate counting and insulin dose adjustment
- Testing their blood sugar levels at least 3 times a day
- Using multiple daily injections of short-acting and long-acting insulin analogues
- With HbA1c between 7.5% and 10%
Key exclusion criteria (6 listed)
- Mental conditions, depression or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Eating disorders
- Pregnancy
- Any clinically significant major organ system disease or infective diseases
- Any disease or condition or abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
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 |
|---|---|---|
| A software programme in mobile telephoneUse of Mobile phone technology in maintaining Diabetes Interactive Diary. | Other | 1 |
| Standard Education Programme.Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition. | Other | 2 |
Primary outcome
The difference in HbA1c between the patient in the DID group and in the standard education group.
Time frame: 6 month
1 secondary outcome
The differences between the two groups in terms of, lipid profile, blood pressure, the number of hypoglycaemic episodes, daily blood sugar fluctuation, total insulin dose, weight changes and patients' satisfaction with the treatment.
Time frame: 6 month
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 10 Jul 2008.
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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.
David Kerr, Doctor principal investigator
Royal Bournemouth Hospital
Anita Bowes, Dietitian principal investigator
Royal Bournemouth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A software programme in mobile telephone and Standard Education Programme. in people with Type 1 Diabetes Mellitus, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
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 6 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 10 Jul 2008. 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 Kingdom. 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?
The difference in HbA1c between the patient in the DID group and in the standard education group. (time frame: 6 month). 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 10 Jul 2008.