Insulin-Dependent Diabetes Mellitus 1NCT04131049

Comparison of Two Different Insulin Dose Calculation Algorithms in Type 1 Diabetes

A study testing High GI calculated by CC (CHGI), Low GI calculated by CC (CLGI) and High GI calculated by FII (FHGI) in people with Insulin-Dependent Diabetes Mellitus 1, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 14 to 18 years
Conditions the study is for: Insulin-Dependent Diabetes Mellitus 1
What is being tested?: High GI calculated by CC (CHGI), Low GI calculated by CC (CLGI) and High GI calculated by FII (FHGI)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 24 Jun 2019to 24 Jan 2020
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 14 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Aged between 14-18 years adolescents
Type 1 diabetes diagnosed for at least one year
Performing self-monitoring of blood glucose and doses of insulin at least four times daily
HbA1c ≤ 9.6% for the last three months
Negative fasting C-peptide (<0.1 nmol/L)
Total daily insulin use of ≥ 0.5 U/kg
World Health Organization BMI/age z-score of -1 to below 3

Who cannot join

Complications of diabetes or other medical conditions including celiac disease
Treatment with oral hypoglycaemic agents
Food allergies, intolerances, or eating disorder
Intestinal malabsorptions
Delayed gastric emptying
Viral or bacterial infection
Physical or mental disability
Clinical condition related to impaired digestive system such as cystic fibrosis

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erciyes University Faculty of Health Sciences
Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Carbohydrate Counting and Food Insulin Index Methods in the Determination of Insulin Doses for High- and Low-Glycemic Index Meals in Adolescents With Type 1 Diabetes

The aim of this study is to compare the impact of carbohydrate counting (CC) method which is standard insulin dose calculation algorithm and food insulin index (FII) method which is a new algorithm on postprandial glucose following a high fat and a high protein meal in adolescent with type 1 diabetes. A randomized, single-blind and crossover trial included 14 adolescents aged 14-18 years with type 1 diabetes. All participants were sent to their homes for 4 consecutive days with a different glycemic index breakfast. The insulin doses of the meals were calculated according to CC and FII methods. Test breakfasts with different GIs and insulin requirements calculated with different algorithms are as follows: High GI calculated by CC (CHGI), low GI calculated by CC (CLGI), high GI calculated by FII (FHGI) and low GI calculated by FII (FLGI).

Conditions: Insulin-Dependent Diabetes Mellitus 1
Being tested: High GI calculated by CC (CHGI), Low GI calculated by CC (CLGI), High GI calculated by FII (FHGI), Low GI calculated by FII (FLGI)
Keywords: Adolescent, Carbohydrate Counting, Food Insulin Index, Glycemic Index, Type 1 diabetes
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.

High GI calculated by CC (CHGI)Other
This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
Low GI calculated by CC (CLGI)Other
This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
High GI calculated by FII (FHGI)Other
This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
Low GI calculated by FII (FLGI)Other
This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.

Study groups in NCT04131049
Study group	Role	What they receive
Carbohydrate Counting	Experimental	The insulin doses of the breakfasts were calculated according to carbohydrate counting. Receives: Other: High GI calculated by CC (CHGI); Other: Low GI calculated by CC (CLGI)
Food Insulin Index	Experimental	The insulin doses of the breakfasts were calculated according to food insulin index. Receives: Other: High GI calculated by FII (FHGI); Other: Low GI calculated by FII (FLGI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Postprandial glucose response by glucometer
Postprandial glucose response was quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using blood glucose values at time points 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes.
Measured: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Postprandial glucose response by continous glucose monitoring
Postprandial glucose response was quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using blood glucose values at time points 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235 and 240 minutes.
Measured: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 201924 Jan 2020

First posted18 Oct 2019
Study start24 Jun 2019
Primary completion24 Nov 2019
Study completion24 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Insulin-Dependent Diabetes Mellitus 1Studies 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: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04131049
Sponsor's protocol ID: 8811
Status last verified: Feb 2021
First submitted: 16 Oct 2019
Last updated: 9 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Erdal B, Caferoglu Z, Hatipoglu N. The comparison of two mealtime insulin dosing algorithms for high and low glycaemic index meals in adolescents with type 1 diabetes. Diabet Med. 2021 Mar;38(3):e14444. doi: 10.1111/dme.14444. Epub 2020 Dec 20.
PubMed 33119135

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruitingObservational study
Epidemiology of Diabetes Interventions and Complications (EDIC)
Type 1 Diabetes Mellitus

All Insulin-Dependent Diabetes Mellitus 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Carbohydrate Counting and Food Insulin Index Methods in the Determination of Insulin Doses for High- and Low-Glycemic Index Meals in Adolescents With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04131049
Acronym / sponsor ID: 8811
Conditions: Insulin-Dependent Diabetes Mellitus 1
Keywords: Adolescent, Carbohydrate Counting, Food Insulin Index, Glycemic Index, Type 1 diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: 24 Jun 2019 (actual)
Primary completion: 24 Nov 2019 (actual)
Study completion: 24 Jan 2020 (actual)
First posted: 18 Oct 2019 (actual)
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.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Carbohydrate Counting	Experimental	Other: High GI calculated by CC (CHGI), Other: Low GI calculated by CC (CLGI)The insulin doses of the breakfasts were calculated according to carbohydrate counting.
Food Insulin Index	Experimental	Other: High GI calculated by FII (FHGI), Other: Low GI calculated by FII (FLGI)The insulin doses of the breakfasts were calculated according to food insulin index.

Who may qualify

Ages: 14 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

Aged between 14-18 years adolescents
Type 1 diabetes diagnosed for at least one year
Performing self-monitoring of blood glucose and doses of insulin at least four times daily
HbA1c ≤ 9.6% for the last three months
Negative fasting C-peptide (<0.1 nmol/L)

Key exclusion criteria (8 listed)

Complications of diabetes or other medical conditions including celiac disease
Treatment with oral hypoglycaemic agents
Food allergies, intolerances, or eating disorder
Intestinal malabsorptions
Delayed gastric emptying

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
High GI calculated by CC (CHGI)This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.	Other	Carbohydrate Counting
Low GI calculated by CC (CLGI)This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.	Other	Carbohydrate Counting
High GI calculated by FII (FHGI)This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.	Other	Food Insulin Index
Low GI calculated by FII (FLGI)This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.	Other	Food Insulin Index

Primary outcome

Postprandial glucose response by glucometer
Time frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Postprandial glucose response was quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using blood glucose values at time points 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes.
Postprandial glucose response by continous glucose monitoring
Time frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Postprandial glucose response was quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using blood glucose values at time points 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235 and 240 minutes.

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 9 Feb 2021.
Derived from this study: PubMed 33119135Erdal B, Caferoglu Z, Hatipoglu N. The comparison of two mealtime insulin dosing algorithms for high and low glycaemic index meals in adolescents with type 1 diabetes. Diabet Med. 2021 Mar;38(3):e14444. doi: 10.1111/dme.14444. Epub 2020 Dec 20.

Related trials for Insulin-Dependent Diabetes Mellitus 1

RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingPhase 4
INfluenza VaccInation To Mitigate typE 1 Diabetes
Diabetes Mellitus, Type 1
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruitingObservational study
Epidemiology of Diabetes Interventions and Complications (EDIC)
Type 1 Diabetes Mellitus

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 8 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 9 Feb 2021. 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 Turkey (Türkiye). 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?

Postprandial glucose response by glucometer (time frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)). 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?

On the ClinicalTrials.gov record for NCT04131049, which also lists 1 linked publication.

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 9 Feb 2021.